Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:54 PM
Study NCT ID:
NCT07460804
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2025-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FOA on Sit to Stand in Individuals Post Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-19', 'size': 295249, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2026-03-04T10:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants will not be aware of their condition allocation compared to the other condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized cross-over study. Participants will be randomized into the internal or external focus of attention condition and one week later they will complete the opposite protocol.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Center of pressure under their feet', 'timeFrame': 'Baseline', 'description': 'HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.'}, {'measure': 'Center of pressure under their feet', 'timeFrame': 'Acquisition (one 1 hour training)', 'description': 'HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.'}, {'measure': 'Center of pressure under their feet', 'timeFrame': 'Immediate Post (5 minutes after acquisition training)', 'description': 'HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.'}, {'measure': 'Center of pressure under their feet', 'timeFrame': 'Long term (one hour after acquisition/training)', 'description': 'HR Pressure mat - Symmetry under the feet will be measured using a 61.26 X 58.72 cm pedobarograph with a 48.8 X 44.7 cm active sensing area during the sit to stand transition. The mat has 3.9 sensors/cm2 with a 185 Hz scanning rate. The mat will be calibrated prior to the start of the study.'}, {'measure': 'Trunk alignment', 'timeFrame': 'Baseline', 'description': 'IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.'}, {'measure': 'Trunk alignment', 'timeFrame': 'Acquisition (one 1 hour training)', 'description': 'IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.'}, {'measure': 'Trunk alignment', 'timeFrame': 'Immediate Post (5 minutes after acquisition training)', 'description': 'IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.'}, {'measure': 'Trunk alignment', 'timeFrame': 'Long term (one hour after training)', 'description': 'IMU sensors -One Delsys inertial measurement units (IMUs) will be placed on the T1 spinous process to capture vertical trunk alignment throughout sit to stand.'}, {'measure': 'Post Manipulation Questionnaire', 'timeFrame': 'Long term (after all measures completed 1 hour after training)', 'description': 'To establish whether participants were thinking about what they were instructed, all individuals were given a post manipulation questionnaire after the 1-hour post training retention testing for each condition. Participants were asked to rate how much they were thinking about "a target that is outside of your body," "how you move your body (e.g. shoulders, hips, trunk)," and about "something else." They responded on a Likert scale with 5 representing very much so and 1 to represent not at all.'}], 'secondaryOutcomes': [{'measure': '% of Gait Cycle in Stance on Affected LE', 'timeFrame': 'Baseline', 'description': "GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time."}, {'measure': '% of Gait Cycle in Stance on Affected LE', 'timeFrame': 'Immediate Post (5 minutes after acquisition training)', 'description': "GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time."}, {'measure': '% of Gait Cycle in Stance on Affected LE', 'timeFrame': 'Long term (one hour after acquisition/training)', 'description': "GaitRite - A 20'X 4' GAITRite will be used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat will be set at 120 Hz sampling rate. All other parameters are fixed. GAITRite software will be used to collect percent of time spent in affected lower extremity stance compared to total stance time."}, {'measure': 'Step Length of Unaffected LE During Gait', 'timeFrame': 'Baseline', 'description': "GaitRite - A 20'X 4' GAITRite was used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat was set at 120 Hz sampling rate. All other parameters were fixed. GAITRite software was used to collect unaffected step length (cm) averaged over 4 passes over the GAITRite mat."}, {'measure': 'Step Length of Unaffected LE During Gait', 'timeFrame': 'Immediate Post (5 minutes after acquisition)', 'description': "GaitRite - A 20'X 4' GAITRite was used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat was set at 120 Hz sampling rate. All other parameters were fixed. GAITRite software was used to collect unaffected step length (cm) averaged over 4 passes over the GAITRite mat."}, {'measure': 'Step Length of Unaffected LE During Gait', 'timeFrame': 'Long term (1 hour after acquisition)', 'description': "GaitRite - A 20'X 4' GAITRite was used to gather gait speed and analyze spatial temporal aspects of gait. The GAITRite mat is an electronic walkway which uses pressure activated sensors to map out foot placement during gait using a quadrilateral blocking system. The walkway is made up of sensor pads, each of which has 2,304 sensors arranged in 48X48 grids. The measurements are provided using x,y coordinates and algorithms in the computer system use this information to group sensors into footprints. The mat has a spatial resolution of 1.27 cm and a spatial resolution accuracy of 1.27 cm. The mat was set at 120 Hz sampling rate. All other parameters were fixed. GAITRite software was used to collect unaffected step length (cm) averaged over 4 passes over the GAITRite mat."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Motor learning', 'Focus of attention', 'Sit to stand'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '9749681', 'type': 'BACKGROUND', 'citation': 'Cheng PT, Liaw MY, Wong MK, Tang FT, Lee MY, Lin PS. The sit-to-stand movement in stroke patients and its correlation with falling. Arch Phys Med Rehabil. 1998 Sep;79(9):1043-6. doi: 10.1016/s0003-9993(98)90168-x.'}, {'pmid': '34843301', 'type': 'BACKGROUND', 'citation': 'Chua LK, Jimenez-Diaz J, Lewthwaite R, Kim T, Wulf G. Superiority of external attentional focus for motor performance and learning: Systematic reviews and meta-analyses. Psychol Bull. 2021 Jun;147(6):618-645. doi: 10.1037/bul0000335.'}, {'type': 'BACKGROUND', 'citation': 'Kakebeeke, T., Knols, R., & de Bruin, E. (2013). Should rehabilitation specialists use external focus instructions when motor learning is fostered? A systematic review. Sports, 1(2), 37-54. https://doi.org/10.3390/sports1020037'}, {'pmid': '30168348', 'type': 'BACKGROUND', 'citation': 'Kal E, Houdijk H, van der Kamp J, Verhoef M, Prosee R, Groet E, Winters M, van Bennekom C, Scherder E. Are the effects of internal focus instructions different from external focus instructions given during balance training in stroke patients? A double-blind randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):207-221. doi: 10.1177/0269215518795243. Epub 2018 Aug 31.'}, {'type': 'BACKGROUND', 'citation': 'Wulf, G. (2013). Attentional focus and motor learning: A review of 15 years. International Review of Sport and Exercise Psychology, 6(1), 77-104. https://doi.org/10.1080/1750984X.2012.723728'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to fill some gaps in the literature by examining the effects of focus of attention on motor learning and motor performance of sit to stand in individuals post chronic stroke. This study will investigate whether an internal or external focus of attention can lead to improved use of the affected lower extremity during the sit to stand transition, while maintaining an upright trunk position. More specifically, the study has two purposes. The first is to determine whether an external or internal focus of attention would lead to better motor learning of sit to stand. This is measured by retention testing and transfer of the task to changes in affected lower extremity weight bearing during gait. The second purpose of this study is to investigate whether an internal or external focus of attention affects the performance of sit to stands during training.', 'detailedDescription': 'Participant demographics and clinical information will be collected, including age, gender, weight, height, location of stroke, how long ago the stroke occurred, and fall history. All participants will consent to participation in this study. The Star Cancellation Test, NIH Stroke Scale (NIHSS), and Montreal Cognitive Assessment (MOCA) will be used to determine eligibility. Fugl Meyer Motor Scale for the lower extremity, excluding reflexes, will also be completed to help describe the sample. Blood pressure, heart rate, and oxygen saturation, via a pulse oximeter, will be taken and a gait belt will be placed on the participant prior to the start of baseline measures. Temporospatial gait parameters will be collected using the GAITRite mat at baseline, 5 minutes after training, and 1 hour after training. Temporospatial gait parameters will be averaged across four passes over the GAITRite mat at each measurement session. Participants will be instructed to \'walk past the end of the mat at your normal comfortable pace\'.\n\nParticipants will then be seated on a hi-lo table with their feet on the HR pressure mat for baseline assessment of sit to stand. Initial mat height will be determined by raising or lowering the mat table until the femur is parallel to the floor. In order to determine this, a level will be lined up from the greater trochanter to the lateral femoral condyle, while the fibula, from fibular head to lateral malleolus, is perpendicular to the floor. This initial mat position will be the height used during each reassessment at baseline, 5 minutes after training, and 1 hour post training. This height will also be used to decide the mat positions needed during training. After the initial mat height is achieved and recorded, an IMU marker will be placed on the superior third of the sternum directly inferior to the sternal notch.\n\nAfter the mat table height is set, participants will be asked to stand up and sit down to determine comfortable foot placement in relation to their knees. The toe of the affected lower extremity will be lined up with the toe of the unaffected side once they have achieved a comfortable foot placement. Tape marks will be placed in front of the toes and on the lateral edges of both feet as well as around the buttocks to allow for a standardized starting position for all assessment timepoints. For all data collection during baseline, 5 minutes post, and 1 hour post training, participants will be instructed to "please stand up three times at your normal speed without your arms if possible". The average force under the affected foot and the average overall force beneath both feet during the sit to stand transition will be captured by the HR pressure mat. The maximal lateral trunk position will be captured throughout this transition by the IMU marker. If individuals need to use their upper extremities this should be recorded.\n\nAfter baseline data collection, participants will be randomized into either the internal or external focus condition. Initial condition allocation will be determined by a random number generator (https://www.random.org), blocks of 6 with a 1:1 ratio. Condition assignment will be sealed in envelopes numbered for each participant by an independent researcher, who will otherwise not be involved in this research study. Condition allocation envelops will be opened directly prior to acquisition trials so baseline assessors will be blinded to group assignment of participants. Participants will be blinded to initial group assignment throughout the entirety of the sessions.\n\nTraining Prior to training, a demonstration of the task will be provided to the participants. Those in the external focus condition will be told, "as you stand up and as you sit down try to bring the targets together like this". Those in the internal focus condition will be told, "as you stand up and as you sit down bring your right/left (R/L) shoulder and R/L hip as far to the R/L as possible." Participants will be asked to perform one repetition with the question "can you show me?". The demonstration is only provided before the first set but these same instructions will be given prior to the start of each successive set during training.\n\nDuring training trials, individuals will perform four sets of ten sit to stand repetitions. During the external focus condition, foam circles will be taped to the participant\'s lateral shoulder and lateral hip. In order to define this distance, participant girth will be measured in a seated position, by measuring the distance between bilateral outer thighs, using greater trochanters as landmarks. When the individual is standing in midline targets will be placed half of this girth measurement plus 10 centimeters away from the lateral tip of their acromion and another target placed the same distance away from their greater trochanter.\n\nDuring training, participants will perform four sets of sit to stand transitions with the mat at progressively lower seat heights to increasingly challenge the participants, with instruction and feedback consistent with their condition allocation. The four sets will occur in the following sequences: 130 percent of the initial mat height determined at baseline assessment, 120 percent, 110 percent and 100 percent. Each set will end after the tenth repetition or when the participant reports a RPE rating of \\>15/20. If participants are unable to complete 10 repetitions, the number completed will be recorded for each trial. Two minute rest breaks will occur between each set or until the participant reports a rate of perceived exertion (RPE) of \\<12/20 on the Borg RPE scale. During training, one verbal correction will be given during each set after the 2nd, 4th, and 7th trials, based on patient performance and condition allocation. The feedback provided will be recorded.\n\nImmediately after the training, participants will take a 5 minute break followed by the post-5 minute retention test in which instrumented sit to stand and gait will be administered. Following the retention test, individuals will complete a general health questionnaire. Approximately one hour after the training ends, 1-hour retention testing will be administered consisting of 3 instrumented sit to stands and gait over the GAITRite. After the immediate long term data collection, the participants will complete the post manipulation questionnaire to determine what the participants were focusing on during training.\n\nAn investigator will guard the participant throughout the entirety of the protocol.\n\nOne week later participants will return and complete the same protocol in the opposite attentional condition to which they were initially randomized. Each session should last 120 to 180 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stroke \\>6 months\n* Mild to moderate stroke (NIHSS scores 0-15)\n\nExclusion Criteria:\n\n* Unable to perform sit to stand from a standard height 20" chair without physical assistance\n* Unable to walk 20 feet with or without an assistive device at a contact guard to independent level\n* Individuals with severe cognitive impairment (\\<10/30 on the Montreal Cognitive assessment)\n* Contraversive pushing (\\> 1 on the Scale for Contraversive Pushing)\n* Neglect as evidenced by \\<44/54 on the star cancellation test\n* Any orthopedic conditions that impact their ability to transition from sit to stand will be excluded from the study.\n* Any other neurologic conditions that impact their ability to transition from sit to stand will be excluded from the study.\n* Minors, prisoners, pregnant women will also be excluded.\n* Non English speaking individuals due to lack of interpretation resources.'}, 'identificationModule': {'nctId': 'NCT07460804', 'acronym': 'FOA Chronic', 'briefTitle': 'FOA on Sit to Stand in Individuals Post Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Western Carolina University'}, 'officialTitle': 'Focus of Attention Effect on Sit to Stand Symmetry in Individuals Post Chronic Stroke: A Randomized Cross-over Trial', 'orgStudyIdInfo': {'id': '1799541'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Internal focus of attention group', 'description': 'Participants were given instructions that make them think about their body\'s movements.\n\nPrior to training, a demonstration of the task was provided to the participants with emphasis to weight shift towards the affected side. For the internal focus condition, participants were told, "as you stand up and as you sit down bring your right/left (R/L) shoulder and R/L hip as far to the R/L as possible." Participants were asked to perform one repetition with the question "can you show me?" The demonstration was only provided before the first set, but the same verbal instructions were given prior to the start of each successive set during training. During training, individuals performed four sets of 10 sit to stand repetitions, yielding a total of 40 repetitions.', 'interventionNames': ['Other: Focus of Attention']}, {'type': 'EXPERIMENTAL', 'label': 'External focus of attention group', 'description': 'Participants were given instructions that make them think about an outside target/outcome.\n\nPrior to training, a demonstration of the task was provided to the participants with emphasis to weight shift towards the affected side. For the internal focus condition, participants were told, "as you stand up and as you sit down try to bring the targets together like this." Participants were asked to perform one repetition with the question "can you show me?" The demonstration was only provided before the first set, but the same verbal instructions were given prior to the start of each successive set during training. During training, individuals performed four sets of 10 sit to stand repetitions, yielding a total of 40 repetitions.', 'interventionNames': ['Other: Focus of Attention']}], 'interventions': [{'name': 'Focus of Attention', 'type': 'OTHER', 'description': 'Focus of attention instruction and feedback. Focus of attention refers to what people are thinking about during motor tasks. An external focus refers to thinking about an outside outcome or target. An internal focus of attention refers to thinking about how someone is moving their body.\n\nDuring training, participants performed four sets of sit to stand transitions with the mat at progressively lower seat heights to increasingly challenge the participants, with instruction and feedback consistent with their condition allocation. The four sets occurred in the following sequences: 130% of the initial mat height determined at baseline assessment 120%, 110%, and 100%. Each set ended after the tenth repetition or when the participant reported an RPE rating of \\>16/20. During training, one verbal correction was given during each set after the second, fourth, and seventh repetition.', 'armGroupLabels': ['External focus of attention group', 'Internal focus of attention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28723', 'city': 'Cullowhee', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley R Watamura, DPT, PhD', 'role': 'CONTACT', 'email': 'awhyatt@email.wcu.edu', 'phone': '7176829710'}, {'name': 'Dave Hudson, PhD', 'role': 'CONTACT', 'email': 'dhudson@email.wcu.edu', 'phone': '8282272191'}, {'name': 'Ashley R Watamura, DPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Western Carolina University', 'geoPoint': {'lat': 35.31371, 'lon': -83.17653}}], 'centralContacts': [{'name': 'Ashley Watamura, PT, DPT, PhD', 'role': 'CONTACT', 'email': 'awhyatt@email.wcu.edu', 'phone': '717-682-9710'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Carolina University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ashley Watamura', 'investigatorAffiliation': 'Western Carolina University'}}}}