Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-29 @ 11:34 AM
Study NCT ID:
NCT05768750
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Home-based Rehabilitation in ARSACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C536787', 'term': 'Spastic ataxia Charlevoix-Saguenay type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012046', 'term': 'Rehabilitation'}], 'ancestors': [{'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants will participate in 2 phases : control phase (12-week usual care) followed by an intervention phase (12-week home-based rehabilitation program).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-03-03', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sitting balance', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome'}, {'measure': 'Change in balance', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance'}, {'measure': 'Change in walking speed', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Change in the walking speed, measured with the time to walk 10 meters at self-selected and maximum speed'}], 'secondaryOutcomes': [{'measure': 'Change in the balance confidence', 'timeFrame': 'Baseline, week 12, week 24', '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 the number of falls', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Number of self-reported falls in the last month'}, {'measure': 'Change in the lower limb coordination', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Number of touched targets in a 30 second period with each foot, measured with the Lower Extremity MOtor COordination Test (LEMOCOT)'}, {'measure': 'Change in the number of sit-to-stand performed in 30 seconds', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Number of complete sit-to-stand performed in 30 seconds without the help of arms'}, {'measure': 'Change in the time required to ascent 10 stairs', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Time required to ascent 10 stairs, measured with the 10 Stairs Ascent'}, {'measure': 'Change in the time required to descent 10 stairs', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Time required to descent 10 stairs, measured with the 10 Stairs Descent'}, {'measure': 'Change in the life space', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Measured with the Life Space Assessment (LSA), score range 0-120, a higher score indicates higher level of mobility in the next five areas: outside the bedroom, outside the house, in the neighborhood, outside of the neighborhood but in town, and outside town during the past four weeks'}, {'measure': 'Change in the upper limb coordination', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Number of finger touched targets in a 20 second period of each side, measured with the Standardized Finger-Nose Test (SFNT)'}, {'measure': 'Change in social participation', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'The performance in activities of daily living, measured with the Assessment of Life Habits (LIFE-H), score range 0-9'}, {'measure': 'Change in the Scale for the assessement and rating of ataxia (SARA)', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Measured with the Scale for the assessment and rating of ataxia (SARA), score range 0-40, higher score indicates higher ataxia severity'}, {'measure': 'Measure of the usability of the program and hardware', 'timeFrame': 'Week 24', 'description': 'Measured with the French System Usability Scale (F-SUS), original score range 0-40 converted to 0-100, a SUS score above a 68 would be considered above average and anything below 68 is below average'}, {'measure': 'Change in sleep components', 'timeFrame': 'Week 12, week 24', 'description': 'The sleep components are measured with an actigraphy watch'}, {'measure': 'Change in mobility components', 'timeFrame': 'Week 12, week 24', 'description': 'The changes in mobility components are measured with an actigraphy watch'}, {'measure': 'Change in the adductor hip muscle group spasticity', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Change in the adductor hip muscle group spasticity, measured with the Modified Ashworth Scale'}, {'measure': 'Change in the knee extensor muscle group spasticity', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Change in the knee extensor muscle group spasticity, measured with the Modified Ashworth Scale'}, {'measure': 'Change in the knee flexor muscle group spasticity', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Change in the knee flexor muscle group spasticity, measured with the Modified Ashworth Scale'}, {'measure': 'Change in the plantar flexor muscle group spasticity', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Change in the plantar flexor muscle group spasticity, measured with the Modified Ashworth Scale'}, {'measure': 'Sum of lower limb muscle spasticity', 'timeFrame': 'Baseline, week 12, week 24', 'description': 'Sum of the spasticity results obtained for the adductor hip, knee extensor, knee flexor and plantar flexor muscle groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ARSACS'], 'conditions': ['Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay']}, 'descriptionModule': {'briefSummary': '48 participants (24 women and 24 men) with autosomal recessive spastic ataxia of Charlevoix-Saguenay (ARSACS) will participate in 2 phases : control phase (12-week usual care) and intervention phase (12-week home-based rehabilitation program). The participants will be evaluated at baseline, week 12 (end of control phase) and week 24 (end of intervention phase) to quantify the effects of an individualized home-based rehabilitation program. Participants will also participate on a focus group at the end of the program to evaluate the acceptability of the program and the perceived changes.', 'detailedDescription': "Co-creation phase:\n\nPreceding the intervention, a co-creation phase involving healthcare professionals (3), patient-partners (2), and ARSACS researchers (3) will be conducted to develop the exercises for the rehabilitation program and the evaluation scale to determine the level of difficulty of each exercise assigned to participants.\n\nIntervention phase:\n\nRandom sampling stratified by gender and level of indoor mobility (unassisted walking, assisted walking, wheelchair) from the Neuromuscular Clinic's registry of 48 participants (24 women and 24 men) will be conducted.\n\n* Control phase: All participants will be asked to maintain their usual activities for 12 weeks.\n* Intervention phase: All participants recruited to the project will complete the home-based rehabilitation program assigned to them for 12 weeks, unsupervised, 20 minutes 3 times a week. Follow-up calls by a physiotherapist will be conducted at weeks 2, 4, 6, 8, 10 and 12."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ARSACS diagnosis must be confirmed by genetic analysis;\n* Women and men, aged between 18 and 50 years old;\n* Be able to perform the sit-to-stand transfer;\n* Consent of the neurologist must be given to participate in this study;\n* Must reside in the Saguenay-Lac-St-Jean region;\n* Subjects must be able to give their consent freely and voluntarily.\n\nExclusion Criteria:\n\n* Patients who already meet physical activity (PA) recommendations (150 min of moderate to high intensity PA/week) or already participate in a rehabilitation program are excluded;\n* Remain in a care facility;\n* Do not speak English or French;\n* Have another diagnosis causing physical limitations;\n* Are pregnant.'}, 'identificationModule': {'nctId': 'NCT05768750', 'acronym': 'PACE-ARSCS', 'briefTitle': 'A Home-based Rehabilitation in ARSACS', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'A Home-based Rehabilitation Program to Counter the Motor Impairments and Activity Limitations Experienced by People With Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay', 'orgStudyIdInfo': {'id': '2021-047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control followed by intervention phase', 'description': 'All participants will participate in 2 phases : control phase (12-week usual care) followed by an intervention phase (12-week home-based rehabilitation program).\n\nThe rehabilitation program consists of three domains of exercises divided by levels of difficulty: sitting balance (16 levels), standing balance (21 levels) and sit-to-stand transfer (12 levels), including 67 exercises. Each individualized home-based rehabilitation program will include 3 to 6 exercises, for a total duration of 15 to 20 minutes.', 'interventionNames': ['Other: Rehabilitation']}], 'interventions': [{'name': 'Rehabilitation', 'type': 'OTHER', 'description': 'X', 'armGroupLabels': ['Control followed by intervention phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G7X 7X2', 'city': 'Saguenay', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Elise Duchesne, Ph.D.', 'role': 'CONTACT', 'email': 'elise1_duchesne@uqac.ca', 'phone': '418-545-5011', 'phoneExt': '6148'}, {'name': 'Elise Duchesne, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Groupe de recherche interdisciplinaire sur les maladies neuromusculaires', 'geoPoint': {'lat': 48.41675, 'lon': -71.06573}}], 'centralContacts': [{'name': 'Elise Duchesne, Ph.D', 'role': 'CONTACT', 'email': 'elise1_duchesne@uqac.ca', 'phone': '418-545-5011', 'phoneExt': '6148'}], 'overallOfficials': [{'name': 'Elise Duchesne, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université du Québec à Chicoutimi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Cynthia Gagnon', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}