Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-30 @ 4:45 AM
Study NCT ID:
NCT05006261
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pbonato@mgh.harvard.edu', 'phone': '617-952-6319', 'title': 'Paolo Bonato, PhD', 'organization': 'Spaulding Rehabilitation Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 14, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back Pain', 'notes': 'Reports of back pain, including low back pain. Most cases were pre-existing with flares occurring during the study. Others reported non-study related activities as the cause. No relation to intervention, all cases mild.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Flu-like illness', 'notes': 'Reports of flu-like symptoms during study. All cases self-resolved with supportive care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Fall', 'notes': 'Reports of falls during non-study-related activities. No medical care required.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Headache', 'notes': 'Reports of headache during non-study-related activities.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Knee Pain', 'notes': 'Reports of knee pain in participants with pre-existing knee pain.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Delayed Onset Muscle Soreness', 'notes': 'Reports of muscle soreness primarily related to non-study-related activities.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Skin Irritation', 'notes': 'Reports of skin irritation related to use of wearable devices.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}, {'term': 'Dizziness', 'notes': 'Reports of dizziness during non-study-related activities.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMED CT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Protocol Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.81', 'spread': '37.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-intervention (approximately 12 weeks)', 'description': 'The percentage of Tai Chi home practice sessions completed by participants.', 'unitOfMeasure': 'percentage of session completed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All dataset was considered'}, {'type': 'PRIMARY', 'title': 'Retention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, approximately 12 weeks from the beginning of the study', 'description': 'The percentage of participants who complete the study.', 'unitOfMeasure': 'percentage of subject retained', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'System Usability Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.18', 'spread': '13.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-intervention (approximately 12 weeks)', 'description': 'The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-intervention (approximately 12 weeks)', 'description': "Qualitative interview about ease of use of the Tele-Tai Chi platform. The outcome will be the percentage of participants who provide positive feedback regarding the platform's ease of use.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All dataset analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Activities-specific Balance Confidence (ABC) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '33.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Activities-specific Balance Confidence (ABC): 16-item self-report measure in which participants rate their balance confidence to perform motor activities. The minimum score is 0. The maximum score is 100. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete and extreme outliers were eliminated. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'title': 'Ability to Participate in Social Roles/Activities', 'categories': [{'measurements': [{'value': '-0.31', 'spread': '2.31', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/Fear', 'categories': [{'measurements': [{'value': '0.10', 'spread': '1.68', 'groupId': 'OG000'}]}]}, {'title': 'Depression and Sadness', 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '-0.78', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Pain Interference', 'categories': [{'measurements': [{'value': '-0.42', 'spread': '1.49', 'groupId': 'OG000'}]}]}, {'title': 'Physical Function', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Sleep Disturbance', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '2.08', 'groupId': 'OG000'}]}]}, {'title': 'Pain Intensity', 'categories': [{'measurements': [{'value': '-0.26', 'spread': '1.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'The PROMIS 29 instrument is a 29-item questionnaire assessing each of the following domains: anxiety, depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, and ability to participate in social roles and activities. The minimum score is 4 per domain, except for pain intensity for which the minimum score is 0. The maximum score per domain is 20, except for pain intensity for which the maximum score is 10. For the physical function and the ability to participate in social roles and activities domains a high score is indicative of positive outcome. For the anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity a low score is indicative of positive outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Physical Activity Scale for the Elderly (PASE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.73', 'spread': '71.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Physical Activity Scale for the Elderly (PASE): self-reported level of physical activity in individuals aged 65 years or older during the previous 7 days. The score accounts for the type of activities performed and the time of performance of each activity. The minimum score is 0. The scale has theoretical maximum value of 864, if subjects spent 24 hours per day over 7 days engaged in vigorous activities. However, as this is not possible, a maximum value of 400 is typically considered as that would correspond to being engage in vigorous activities for 8 hours per day + more moderate activities for 4.5 hours per day.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Trail Making Test A/B Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'title': 'Part A', 'categories': [{'measurements': [{'value': '-0.24', 'spread': '7.81', 'groupId': 'OG000'}]}]}, {'title': 'Part B', 'categories': [{'measurements': [{'value': '-3.37', 'spread': '35.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Trail Making Test (TMT): Test to assess executive cognitive function. It has two parts: TMT A (number sequence only) considers visual search, and TMT B (alternating numbers and letters) evaluates executive control. The participant is asked to draw a line between 24 circles randomly arranged on a page that have to be linked in consecutive order. The TMT is scored by how long it takes to complete the test.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis. For the analysis of Part A only 24 patients were considered.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Self-Efficacy Exercise (SEE) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.6', 'spread': '19.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Exercise Self-efficacy Questionnaire (SEE): 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults. The minimum score is 0. The maximum score is 90. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Tai Chi Proficiency Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.42', 'spread': '2.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline at Post-Intervention (approximately 12 weeks)', 'description': 'Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the six Tai Chi movements performed by participants. The minimum score is 6. The maximum score is 30 per Tai Chi exercise. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. The change in Tai Chi proficiency score ranges from -24 to +24. A change equal to 0 represents no change in proficiency.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Timed-Up-and-Go', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'spread': '1.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Timed-Up-and-Go: Test to determine fall risk. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Timed-Up-and-Go Dual Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '1.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Dual task Timed-Up-and-Go test: The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair while counting backwards by three.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Single Leg Stance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'title': 'Left Leg', 'categories': [{'measurements': [{'value': '1.75', 'spread': '7.67', 'groupId': 'OG000'}]}]}, {'title': 'Right Leg', 'categories': [{'measurements': [{'value': '0.73', 'spread': '10.04', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Balance on each leg (two trials): The participant is asked to stand on one leg for as long as they can up to a maximum of 30 seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Sit-to-Stand Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '1.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Sit-to-Stand Test: The participant is asked to stand up from a chair while keeping their arms crossed across their chest and repeat the task as many times as possible during a period of 30 seconds. A higher count of completed repetitions is considered indicative of improved performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset is incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'title': 'AP-Baseline', 'categories': [{'measurements': [{'value': '60.03', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'AP-Post Intervention', 'categories': [{'measurements': [{'value': '60.73', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'ML-Baseline', 'categories': [{'measurements': [{'value': '60.05', 'spread': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'ML-Post Intervention', 'categories': [{'measurements': [{'value': '60.48', 'spread': '0.92', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Balance on both legs with feet shoulder-width apart: The participant is asked to stand with feet shoulder-width apart for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for each condition for a total of 4 variables.', 'unitOfMeasure': 'millimeters per second squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis. The root mean square (RMS) value of the acceleration in the antero-posterior (AP) and medio-lateral (ML) directions at the waist sensor was calculated for middle 15 seconds of each experiment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Postural Sway and Balance on Both Legs With Feet Close to Each Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'title': 'AP - Baseline', 'categories': [{'measurements': [{'value': '60.14', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'AP - Post Intervention', 'categories': [{'measurements': [{'value': '60.57', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'ML - Baseline', 'categories': [{'measurements': [{'value': '59.93', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'ML - Post Intervention', 'categories': [{'measurements': [{'value': '60.35', 'spread': '0.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Balance on both legs with feet close to each other: The participant is asked to stand with feet as close as possible (without contact between the feet) for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for a total of 4 variables.', 'unitOfMeasure': 'millimeters per second squared', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analysis was limited only to subjects who completed in the intervention and completed both baseline and post-intervention assessments. The root mean square (RMS) value of the acceleration in the antero-posterior (AP) and medio-lateral (ML) directions at the waist sensor was calculated for middle 15 seconds of each experiment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Normalized-to-height Stride Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'title': 'Normalized Stride Length - Baseline (unitless)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': 'Normalized Stride Length - Post Intervention (unitless)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Study participants will undergo an instrumented gait evaluation. Stride length will be defined as the distance from ipsilateral foot contact to the next ipsilateral foot contact during gait. Normalized-to-height stride length will be derived by computing the stride length using the gait evaluation equipment and dividing such value by the height of the study participant.', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset is incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stride Time Variability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'title': 'Stride Time Variability - Baseline', 'categories': [{'measurements': [{'value': '10.32', 'spread': '8.79', 'groupId': 'OG000'}]}]}, {'title': 'Stride Time Variability - Discharge', 'categories': [{'measurements': [{'value': '12.27', 'spread': '14.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Study participants will undergo an instrumented gait evaluation. Stride time will be defined as the time interval between two consecutive foot contacts of the same limb. Stride time variability will be computed as the standard deviation of the stride time estimates derived using the gait evaluation equipment.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '1044', 'spread': '2526', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of intervention (approximately 12 weeks)', 'description': 'Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor.', 'unitOfMeasure': 'steps per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The dataset was incomplete. Participants with missing data were excluded from the analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Changes From Baseline in Mini-Balance Evaluation Systems Test (MiniBEST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '1.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and end of intervention (approximately 12 weeks)', 'description': 'MiniBEST Test: Test to assess dynamic balance. It is a 14-item test scored using a three-level ordinal scale. This test will be performed only in individuals who are willing to be tested in the laboratory (as opposed to via a remote visit). The minimum score is 0. The maximum score is 28. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data analysis was limited only to subjects who completed both baseline and post-intervention assessments in the laboratory.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention\n\nTele-Tai Chi: 12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '65', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-06', 'size': 511991, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-14T00:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-17', 'studyFirstSubmitDate': '2021-07-27', 'resultsFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2021-08-06', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-17', 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)', 'timeFrame': 'Post-intervention (approximately 12 weeks)', 'description': "Qualitative interview about ease of use of the Tele-Tai Chi platform. The outcome will be the percentage of participants who provide positive feedback regarding the platform's ease of use."}, {'measure': 'Changes From Baseline in Activities-specific Balance Confidence (ABC) Scores', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Activities-specific Balance Confidence (ABC): 16-item self-report measure in which participants rate their balance confidence to perform motor activities. The minimum score is 0. The maximum score is 100. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.'}, {'measure': 'Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'The PROMIS 29 instrument is a 29-item questionnaire assessing each of the following domains: anxiety, depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, and ability to participate in social roles and activities. The minimum score is 4 per domain, except for pain intensity for which the minimum score is 0. The maximum score per domain is 20, except for pain intensity for which the maximum score is 10. For the physical function and the ability to participate in social roles and activities domains a high score is indicative of positive outcome. For the anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity a low score is indicative of positive outcome.'}, {'measure': 'Changes From Baseline in Physical Activity Scale for the Elderly (PASE)', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Physical Activity Scale for the Elderly (PASE): self-reported level of physical activity in individuals aged 65 years or older during the previous 7 days. The score accounts for the type of activities performed and the time of performance of each activity. The minimum score is 0. The scale has theoretical maximum value of 864, if subjects spent 24 hours per day over 7 days engaged in vigorous activities. However, as this is not possible, a maximum value of 400 is typically considered as that would correspond to being engage in vigorous activities for 8 hours per day + more moderate activities for 4.5 hours per day.'}, {'measure': 'Changes From Baseline in Trail Making Test A/B Scores', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Trail Making Test (TMT): Test to assess executive cognitive function. It has two parts: TMT A (number sequence only) considers visual search, and TMT B (alternating numbers and letters) evaluates executive control. The participant is asked to draw a line between 24 circles randomly arranged on a page that have to be linked in consecutive order. The TMT is scored by how long it takes to complete the test.'}, {'measure': 'Changes From Baseline in Self-Efficacy Exercise (SEE) Questionnaire', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Exercise Self-efficacy Questionnaire (SEE): 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults. The minimum score is 0. The maximum score is 90. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.'}, {'measure': 'Changes From Baseline in Tai Chi Proficiency Scores', 'timeFrame': 'Change from Baseline at Post-Intervention (approximately 12 weeks)', 'description': 'Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the six Tai Chi movements performed by participants. The minimum score is 6. The maximum score is 30 per Tai Chi exercise. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. The change in Tai Chi proficiency score ranges from -24 to +24. A change equal to 0 represents no change in proficiency.'}, {'measure': 'Changes From Baseline in Timed-Up-and-Go', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Timed-Up-and-Go: Test to determine fall risk. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair.'}, {'measure': 'Changes From Baseline in Timed-Up-and-Go Dual Task', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Dual task Timed-Up-and-Go test: The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair while counting backwards by three.'}, {'measure': 'Changes From Baseline in Single Leg Stance', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Balance on each leg (two trials): The participant is asked to stand on one leg for as long as they can up to a maximum of 30 seconds.'}, {'measure': 'Changes From Baseline in Sit-to-Stand Performance', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Sit-to-Stand Test: The participant is asked to stand up from a chair while keeping their arms crossed across their chest and repeat the task as many times as possible during a period of 30 seconds. A higher count of completed repetitions is considered indicative of improved performance.'}, {'measure': 'Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Balance on both legs with feet shoulder-width apart: The participant is asked to stand with feet shoulder-width apart for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for each condition for a total of 4 variables.'}, {'measure': 'Postural Sway and Balance on Both Legs With Feet Close to Each Other', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Balance on both legs with feet close to each other: The participant is asked to stand with feet as close as possible (without contact between the feet) for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for a total of 4 variables.'}, {'measure': 'Normalized-to-height Stride Length', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Study participants will undergo an instrumented gait evaluation. Stride length will be defined as the distance from ipsilateral foot contact to the next ipsilateral foot contact during gait. Normalized-to-height stride length will be derived by computing the stride length using the gait evaluation equipment and dividing such value by the height of the study participant.'}, {'measure': 'Stride Time Variability', 'timeFrame': 'Baseline and post-intervention (approximately 12 weeks)', 'description': 'Study participants will undergo an instrumented gait evaluation. Stride time will be defined as the time interval between two consecutive foot contacts of the same limb. Stride time variability will be computed as the standard deviation of the stride time estimates derived using the gait evaluation equipment.'}, {'measure': 'Changes From Baseline in Activity Level', 'timeFrame': 'Baseline and end of intervention (approximately 12 weeks)', 'description': 'Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor.'}, {'measure': 'Changes From Baseline in Mini-Balance Evaluation Systems Test (MiniBEST)', 'timeFrame': 'Baseline and end of intervention (approximately 12 weeks)', 'description': 'MiniBEST Test: Test to assess dynamic balance. It is a 14-item test scored using a three-level ordinal scale. This test will be performed only in individuals who are willing to be tested in the laboratory (as opposed to via a remote visit). The minimum score is 0. The maximum score is 28. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.'}], 'primaryOutcomes': [{'measure': 'Protocol Adherence', 'timeFrame': 'Post-intervention (approximately 12 weeks)', 'description': 'The percentage of Tai Chi home practice sessions completed by participants.'}, {'measure': 'Retention', 'timeFrame': 'Through study completion, approximately 12 weeks from the beginning of the study', 'description': 'The percentage of participants who complete the study.'}, {'measure': 'System Usability Scale', 'timeFrame': 'Post-intervention (approximately 12 weeks)', 'description': 'The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy Aging']}, 'descriptionModule': {'briefSummary': 'This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.', 'detailedDescription': 'The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naïve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, and gait, and evaluate changes in TC proficiency.\n\nOver the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks).\n\nStudy volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 live sessions with TC instructors two or more times during the study period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women between 60 and 85 years old\n* TC naïve (i.e., never practiced TC)\n* Self-reported ability to walk continuously for 15 minutes without an assistive device\n* Working email address\n* Prior experience with and current access to a computer, smart phone or tablet device\n\nExclusion Criteria:\n\n* Chronic neuromuscular conditions (e.g. Parkinson's disease, multiple sclerosis, stroke)\n* Acute medical conditions requiring hospitalization within the past 6 months or that could interfere with the ability of prospective volunteers to safely participate in the study\n* Active cancer\n* Significant musculoskeletal conditions requiring chronic use of pain medication\n* Cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score \\< 18)"}, 'identificationModule': {'nctId': 'NCT05006261', 'briefTitle': 'A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II', 'orgStudyIdInfo': {'id': '2020P002974'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tele-Tai Chi', 'description': 'Tele-Tai Chi intervention', 'interventionNames': ['Device: Tele-Tai Chi']}], 'interventions': [{'name': 'Tele-Tai Chi', 'type': 'DEVICE', 'description': '12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.', 'armGroupLabels': ['Tele-Tai Chi']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Paolo Bonato, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Motion Analysis Laboratory', 'investigatorFullName': 'Paolo Bonato', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}