Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 8:26 PM
Study NCT ID:
NCT05479656
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536787', 'term': 'Spastic ataxia Charlevoix-Saguenay type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Scale for the assessement and rating of ataxia (SARA)', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Measured with the Scale for the assessement and rating of ataxia (SARA), score range 0-40, higher score indicates higer ataxia severity'}], 'secondaryOutcomes': [{'measure': 'Change in walking speed', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Change in the walking speed, measured with the time to walk 10 meters at comfortable and maximum speed'}, {'measure': 'Change in the number of sit-to-stand performed in 30 seconds', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Number of complete sit-to-stand performed in 30 seconds without the help of arms'}, {'measure': 'Change in the balance confidence', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Measured with the modified Activities-specific Balance Confidence (ABC) Scale, score range 0-100, 0 indicates no confidence and 100 is full confidence.'}, {'measure': 'Change in balance', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance.'}, {'measure': 'Change in sitting balance', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome.'}, {'measure': 'Change in the level of independence to perform daily living activities', 'timeFrame': 'Baseline, week 4, week 8', 'description': 'Measured with the Barthel Index, score range 0-100, a higher score indicates a higher level of independence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay']}, 'descriptionModule': {'briefSummary': 'This exploratory study used a pre-post test design. The supervised rehabilitation program was performed three times a week for 8 weeks (two sessions at a rehabilitation gym and one pool session). Outcome measures included Ottawa sitting scale, 30-Second Chair Stand test, Berg Balance Scale, 10-Meter Walk Test, 6-minute Walk Test, modified Activities-specific Balance Confidence Scale and SARA scale. 10 participants will complete the training program. They will be evaluated at baseline, at week 4 (miway) and after the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Genetically confirmed ARSACS diagnosis; walker (indoor walking abilities with or without walking aids); ability to walk 10 meters; ability to provide informed consent\n\nExclusion Criteria:\n\n* Having other medical diagnosis causing physical limitations'}, 'identificationModule': {'nctId': 'NCT05479656', 'briefTitle': 'A Rehabilitation Program to Increase Balance and Mobility in Ataxia of Charlevoix-Saguenay', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'A Better Trunk and Lower Limb Control for a Better Mobility: Assessment of a Re-entrainment Program in Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay', 'orgStudyIdInfo': {'id': '2019-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training program', 'description': '8-week rehabilitation program aimed at increasing trunk and lower limb motor control on balance and walking abilities, and accomplishment of activities of daily living.', 'interventionNames': ['Other: Training program']}], 'interventions': [{'name': 'Training program', 'type': 'OTHER', 'description': '8-week rehabilitation program aimed at increasing trunk and lower limb motor control on balance and walking abilities, and accomplishment of activities of daily living.', 'armGroupLabels': ['Training program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G7X 7X2', 'city': 'Saguenay', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Groupe de recherche interdisciplinaire sur les maladies neuromusculaires', 'geoPoint': {'lat': 48.41675, 'lon': -71.06573}}], 'overallOfficials': [{'name': 'Cynthia Gagnon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sherbrooke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Élise Duchesne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Muscular Dystrophy Canada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Élise Duchesne', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}