None listed
Conditions
Brief summary
Friedreich Ataxia is a degenerative disease impacting on the ability to mobilise and reducing independence in daily activities. This study aims to determine if outpatient rehabilitation improves or maintains functional ability and quality of life, as compared to a wait-list control. People attending a specialist multidisciplinary Friedreich ataxia clinic and who would benefit from rehabilitation, will be invited by the clinic to participate in this study. Consent will be gained at the Kingston Centre Participants appropriate for outpatient rehabilitation will be randomised into an intervention group or a control group, using a computer program. Intervention will be ‘accelerated’ standard-care, rehabilitation including physiotherapy, aquatic physiotherapy and exercises, and the wait-list period of the program will generate the control group. The duration of rehabilitation will be 6 weeks, and rehabilitation will be provided three times per week. A home exercise program will provided for participants in both groups to complete for six weeks following the rehabilitation program. Outcome measures will examine quality of life, disease progression, performance of daily life activities, mobility and spasticity. These measures will be taken at baseline, pre and post-rehabilitation, and six weeks following rehabilitation.
Interventions
An individualised rehabilitation program, consisting of a minimum of 2 hours and 15 minutes of therapy (physiotherapy, exercise physiology and/or allied health assistant supervised exercise therapy and aquatic physiotherapy), 3 times per week as per usual clinical care. In order to provide an individualised rehabilitation program, the treating physiotherapist will conduct a thorough assessment of the participant’s function and impairments. The treating physiotherapist will get access to outome
An individualised rehabilitation program, consisting of a minimum of 2 hours and 15 minutes of therapy (physiotherapy, exercise physiology and/or allied health assistant supervised exercise therapy and aquatic physiotherapy), 3 times per week as per usual clinical care. In order to provide an individualised rehabilitation program, the treating physiotherapist will conduct a thorough assessment of the participant’s function and impairments. The treating physiotherapist will get access to outome measures, including the Goal Attainment Scale from the first blinded-assessment in order to individualise the rehabilitation program to the participant’s specific goals. rehabilitation will be broken down into domains in order to address the specific impairments which may contribute to functional decline. Rehabilitation will be separated into seven ‘domains’: coordination and control exercises, functional mobility, strengthening, cardiovascular fitness and muscle endurance, core-stability, balance training, and stretching. Sessions may be one-on-one, in a group setting or a combination of both. In addition, a home exercise program (HEP) will be given to the participant, to be commenced immediately after the period of intervention, as per standard practice. The home exercise program will consist of any of/or a combination of aquatic exercises, home based exercises or a gym program. This content will be determined by participant and rehabilitation/treating physiotherapist. The HEP will be prescribed during the intervention
Sponsors
Sarah Milne
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Homozygosity for a GAA expansion in intron 1 of FXN 2. Aged 15 years and over 3. Able to give informed consent 4. Understand written and verbal English 5. Reduction in functional capacity and/or need for physical rehabilitation intervention 6. Able and willing to participate and attend a six-week outpatient rehabilitation program at the Kingston Centre 7. Have a FARS Functional Staging Score 2-5 (Symptoms present, recognized by patient, but still mild – Confined but can navigate a wheelchair and can perform some activities of daily living that do not require standing or walking)
Exclusion criteria
1. Compound heterozygotes for a GAA expansion in intron 1 and a point mutation/deletion in FXN 2. Aged under 15 years 3. Acute orthopaedic injury limiting ability to weight-bear 4. Pregnancy 5. Living rurally or interstate with no other means of accommodation 6. Those unable to access the outpatient program due to transport issues 7. Need for immediate physiotherapy intervention for safety reasons (i.e. unable to be waitlisted) 8. Those requiring greater than three days per week of intervention (i.e. need for serial casting, multiple falls at home, pain) as assessed by the Friedreich ataxia Clinic multidisciplinary team 9. Other illness that has acutely reduced functional capacity 10. Received botulinum injections or undergone major orthopaedic surgery in last 6 months
Outcome results
None listed