Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT06156969
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2023-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PBONATO@mgh.harvard.edu', 'phone': '617-952-6319', 'title': 'Paolo Bonato, PhD', 'organization': 'Spaulding Rehabilitation Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to study completion, on average 7 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes.", 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'Surface electromyographic (EMG) data collected from 16 muscles of the lower limbs during overground gait will be analyzed using the non-negative matrix factorization technique to quantify the patterns of co-activation of muscles. Cosine similarity values will be estimated for the EMG recordings collected pre- and post-intervention. Cosine similarity values will range between 0 and 1, where 1 means that the patterns of co-activation are identical to normative whereas 0 means that they are completely different (as they do not overlap). The percentage of muscle synergies displaying an increase in cosine similarity will be reported.', 'unitOfMeasure': 'percentage of muscle synergies', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in the similarity of muscle synergies recorded from children with CP pre vs post-intervention using normative muscle synergies as a reference'}, {'type': 'SECONDARY', 'title': 'Change in Gross Motor Function Measure (GMFM) Dimension D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '8.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'The GMFM Dimension D consists of a battery of thirteen motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension D of the scale is focused on standing function. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 39. Higher values represent better function. The change from baseline to post-intervention is calculated by taking the difference between the value gathered post-intervention and the value gathered pre-intervention.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in the Gross Motor Function Measure (GMFM) Dimension D score pre- vs post-intervention'}, {'type': 'SECONDARY', 'title': 'Change in Gross Motor Function Measure (GMFM) Dimension E', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '9.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'The GMFM Dimension E consists of a battery of twenty-four motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension E of the scale is focused on walking function. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 72. Higher values represent a better function. The change from baseline to post-intervention is calculated by taking the difference between the value gathered post-intervention and the value gathered pre-intervention.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in Gross Motor Function Measure (GMFM) Dimension E pre- vs post-intervention'}, {'type': 'SECONDARY', 'title': 'Percent Change in 10-Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '28.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'Study staff will use a stopwatch to measure the time needed by study participants to cover a distance of 10 meters.', 'unitOfMeasure': 'percentage of baseline value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in walking speed relative to baseline (i.e., pre-training)'}, {'type': 'SECONDARY', 'title': 'Percent Change in 6-Minutes Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'classes': [{'categories': [{'measurements': [{'value': '23.5', 'spread': '37.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'Study staff will measure the distance walked by study participants during an interval of 6 min.', 'unitOfMeasure': 'percentage of baseline walking distance', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in endurance as increase in walking distance relative to baseline (i.e., pre-training)'}, {'type': 'SECONDARY', 'title': 'Percent Change in Edinburgh Visual Gait Scores (EVGS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'spread': '12.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'The EVGS score is a standardized measure of gait quality derived using criteria based on visual observation of gait patterns in children with cerebral palsy. The EVGS includes 17 gait parameters and uses a three-point ordinal scale for each parameter, corresponding to normal, moderate, and severe deviation, respectively. The total score range is from 0 to 34 points, where 0 corresponds to normal gait and greater than 0 indicates gait abnormality.', 'unitOfMeasure': 'percentage of baseline value', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Changes in quality of gait as captured by the Edinburgh Visual Gait Scores (EVGS) relative to baseline (i.e., pre-training) value'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Robot-assisted Gait Training', 'description': "Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.\n\nRobot-Assisted Gait Training: Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '3.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', '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': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', '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': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gross Motor Function Classification System (GMFCS)', 'classes': [{'categories': [{'title': 'Level I', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Level II', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Level III', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Level IV', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Gross Motor Function Classification System (GMFCS is a five-level clinical classification system, from the least to the most severe, that describes the gross motor function of children and youth with cerebral palsy based on self-initiated movement abilities and the need for assistive devices such as walkers or wheelchairs. Level I: Walks without limitations; Level II: Walks with limitations; Level III: Walks using a hand-held mobility device; Level IV: Self-mobility with limitations; may use powered mobility; and Level V: Transported in manual wheelchair.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-03', 'size': 445281, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-26T15:38', 'hasProtocol': True}, {'date': '2019-05-03', 'size': 101222, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-06T15:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-17', 'studyFirstSubmitDate': '2023-11-27', 'resultsFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2023-11-27', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-17', 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'Surface electromyographic (EMG) data collected from 16 muscles of the lower limbs during overground gait will be analyzed using the non-negative matrix factorization technique to quantify the patterns of co-activation of muscles. Cosine similarity values will be estimated for the EMG recordings collected pre- and post-intervention. Cosine similarity values will range between 0 and 1, where 1 means that the patterns of co-activation are identical to normative whereas 0 means that they are completely different (as they do not overlap). The percentage of muscle synergies displaying an increase in cosine similarity will be reported.'}], 'secondaryOutcomes': [{'measure': 'Change in Gross Motor Function Measure (GMFM) Dimension D', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'The GMFM Dimension D consists of a battery of thirteen motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension D of the scale is focused on standing function. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 39. Higher values represent better function. The change from baseline to post-intervention is calculated by taking the difference between the value gathered post-intervention and the value gathered pre-intervention.'}, {'measure': 'Change in Gross Motor Function Measure (GMFM) Dimension E', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'The GMFM Dimension E consists of a battery of twenty-four motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension E of the scale is focused on walking function. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 72. Higher values represent a better function. The change from baseline to post-intervention is calculated by taking the difference between the value gathered post-intervention and the value gathered pre-intervention.'}, {'measure': 'Percent Change in 10-Meter Walk Test', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'Study staff will use a stopwatch to measure the time needed by study participants to cover a distance of 10 meters.'}, {'measure': 'Percent Change in 6-Minutes Walk Test', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'Study staff will measure the distance walked by study participants during an interval of 6 min.'}, {'measure': 'Percent Change in Edinburgh Visual Gait Scores (EVGS)', 'timeFrame': 'Data collected at baseline and at completion of the 7-week intervention', 'description': 'The EVGS score is a standardized measure of gait quality derived using criteria based on visual observation of gait patterns in children with cerebral palsy. The EVGS includes 17 gait parameters and uses a three-point ordinal scale for each parameter, corresponding to normal, moderate, and severe deviation, respectively. The total score range is from 0 to 34 points, where 0 corresponds to normal gait and greater than 0 indicates gait abnormality.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'Robotics', 'Gait rehabilitation'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This is a single-arm longitudinal study for children with cerebral palsy with gait impairments that involves robot-assisted gait training (RGT) and includes pre and post-data collection visits. The study aims to evaluate changes in muscle synergies in children with Cerebral Palsy (CP) in response to RGT. Additionally, the study aims to investigate the relationship between muscle synergies and the clinical outcomes of RGT.', 'detailedDescription': 'Participants will be assessed 2 times - before and after training with the robot. All the testing and training sessions will be carried out at Spaulding Rehabilitation Hospital and will include:\n\nClinical tests:\n\n* A test to evaluate gross motor function\n* A test to assess walking speed\n* A test to assess endurance\n\nMuscle activity tests:\n\n* A test to derive detailed measures of how well participant walk using a camera-based motion capture system.\n* Special sensors (called electromyographic - EMG - sensors) will be used to determine when and how muscles are recruited to generate movements.\n\nTraining with the Robot:\n\nStudy participants will undergo 18 sessions of robot-assisted gait training for 18 time The training sessions will be carried out by trained study staff. The robot will assist study participants to walk. Each training session will last about 1 hour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of spastic cerebral palsy\n* 6 to 18 years of age\n* Gross Motor Function (GMFCS) Level I, II, III or IV\n* Femoral length \\< size of robotic exoskeleton used for gait training (femur length between 210-350mm)\n* Ability to communicate pain or discomfort\n\nExclusion Criteria:\n\n* Recent use of Lokomat within the last 3 months\n* Contraindication to robotic-assisted gait training such us thromboembolic disease, progressive neurologic disorder, cardiovascular or pulmonary contraindications, aggressive behaviors, severe cognitive deficits, bone instabilities, fractures, osteoporosis)\n* Skin ulcers in trunk or lower limbs\n* Hip, knee, ankle arthrodesis'}, 'identificationModule': {'nctId': 'NCT06156969', 'briefTitle': 'Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy', 'orgStudyIdInfo': {'id': '2015P001482'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robot-assisted gait training', 'description': 'Robot-Assisted Gait Training using the LokomatPro device. Total of 18 training sessions, over a period of approximately 6-7 weeks. Sessions will last approximately 60 minutes.', 'interventionNames': ['Device: Robot-Assisted Gait Training']}], 'interventions': [{'name': 'Robot-Assisted Gait Training', 'type': 'DEVICE', 'description': "Training will be performed using the LokomatPro. The Lokomat consists of a driven (motorized) gait orthosis (DGO) and an advanced body weight support system, combined with a treadmill. It uses computer-controlled motors which are integrated in the gait orthosis at each hip and knee joint. The exoskeleton is secured to a person's lower limbs using straps.\n\nTraining protocol: Each training session will include 30 minutes of gait training. Training will take over a period of about 6-7 weeks. Sessions will last approximately 60 minutes.", 'armGroupLabels': ['Robot-assisted gait training']}]}, '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'}}}}