A Home-based Rehabilitation in ARSACS

Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay Clinical Trial

— PACE-ARSCS  

Official title:

A Home-based Rehabilitation Program to Counter the Motor Impairments and Activity Limitations Experienced by People With Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768750
• Other study ID #: 2021-047
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Université de Sherbrooke
• Contact: Elise Duchesne, Ph.D
• Phone: 418-545-5011
• Email: elise1_duchesne[@]uqac.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Co-creation phase:

Preceding 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.

Intervention phase:

Random 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.

• Control phase: All participants will be asked to maintain their usual activities for 12 weeks.

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• ARSACS diagnosis must be confirmed by genetic analysis;

• Women and men, aged between 18 and 50 years old;

• Be able to perform the sit-to-stand transfer;

• Consent of the neurologist must be given to participate in this study;

• Must reside in the Saguenay-Lac-St-Jean region;

• Subjects must be able to give their consent freely and voluntarily.

Exclusion Criteria:

• 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;

• Remain in a care facility;

• Do not speak English or French;

• Have another diagnosis causing physical limitations;

• Are pregnant.

Related Conditions & MeSH terms

• Ataxia
• Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay
• Muscle Spasticity
• Spinocerebellar Ataxias

Intervention

Other:
• Rehabilitation
X

Locations

Country	Name	City	State
Canada	Groupe de recherche interdisciplinaire sur les maladies neuromusculaires	Saguenay	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sitting balance	Measured with the Ottawa sitting scale, score range 0-40, a higher score indicates a better outcome	Baseline, week 12, week 24
Primary	Change in balance	Measured with the Berg Balance Scale, score range 0-56, a higher score indicates better balance	Baseline, week 12, week 24
Primary	Change in walking speed	Change in the walking speed, measured with the time to walk 10 meters at self-selected and maximum speed	Baseline, week 12, week 24
Secondary	Change in the balance confidence	Measured with the modified Activities-specific Balance Confidence (ABC) Scale, score range 0-100, 0 indicates no confidence and 100 is full confidence	Baseline, week 12, week 24
Secondary	Change in the number of falls	Number of self-reported falls in the last month	Baseline, week 12, week 24
Secondary	Change in the lower limb coordination	Number of touched targets in a 30 second period with each foot, measured with the Lower Extremity MOtor COordination Test (LEMOCOT)	Baseline, week 12, week 24
Secondary	Change in the number of sit-to-stand performed in 30 seconds	Number of complete sit-to-stand performed in 30 seconds without the help of arms	Baseline, week 12, week 24
Secondary	Change in the time required to ascent 10 stairs	Time required to ascent 10 stairs, measured with the 10 Stairs Ascent	Baseline, week 12, week 24
Secondary	Change in the time required to descent 10 stairs	Time required to descent 10 stairs, measured with the 10 Stairs Descent	Baseline, week 12, week 24
Secondary	Change in the life space	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	Baseline, week 12, week 24
Secondary	Change in the upper limb coordination	Number of finger touched targets in a 20 second period of each side, measured with the Standardized Finger-Nose Test (SFNT)	Baseline, week 12, week 24
Secondary	Change in social participation	The performance in activities of daily living, measured with the Assessment of Life Habits (LIFE-H), score range 0-9	Baseline, week 12, week 24
Secondary	Change in the Scale for the assessement and rating of ataxia (SARA)	Measured with the Scale for the assessment and rating of ataxia (SARA), score range 0-40, higher score indicates higher ataxia severity	Baseline, week 12, week 24
Secondary	Measure of the usability of the program and hardware	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	Week 24
Secondary	Change in sleep components	The sleep components are measured with an actigraphy watch	Week 12, week 24
Secondary	Change in mobility components	The changes in mobility components are measured with an actigraphy watch	Week 12, week 24
Secondary	Change in the adductor hip muscle group spasticity	Change in the adductor hip muscle group spasticity, measured with the Modified Ashworth Scale	Baseline, week 12, week 24
Secondary	Change in the knee extensor muscle group spasticity	Change in the knee extensor muscle group spasticity, measured with the Modified Ashworth Scale	Baseline, week 12, week 24
Secondary	Change in the knee flexor muscle group spasticity	Change in the knee flexor muscle group spasticity, measured with the Modified Ashworth Scale	Baseline, week 12, week 24
Secondary	Change in the plantar flexor muscle group spasticity	Change in the plantar flexor muscle group spasticity, measured with the Modified Ashworth Scale	Baseline, week 12, week 24
Secondary	Sum of lower limb muscle spasticity	Sum of the spasticity results obtained for the adductor hip, knee extensor, knee flexor and plantar flexor muscle groups	Baseline, week 12, week 24