None listed
Conditions
Brief summary
Impaired arm and hand function is a common and often devastating problem for stroke survivors. Regaining lost movement in the arm/hand is more difficult to achieve than walking, with only 5% of people with hemiplegia regaining functional use of their hand. This devastating outcome could potentially be addressed, however we do not yet know how to best increase movement in the arm and hand after stroke for patients with spasticity. There is a lack of randomized controlled trials of botulinum toxin A (BoNT-A) with a group who does not receive therapy in some dose, and so whether gains were achieved through BoNT-A or a combination of the BoNT-A and therapy cannot be determined from the studies to date.The research project is testing whether intense therapy given after botulinum toxin injections into the arm is more helpful than just the injections alone.
Interventions
An evidence-based therapy program is provided for 12 weeks immediately following botulinum toxin-A injection. The program commences with:
(1) Up to 3 serial casts applied to place the wrist in maximum extension for 2 weeks. Cast is applied the first working day following botulinum toxin-A injection; followed by
(2) 10 weeks of movement training, aimed at decreasing weakness (electrical stimulation and progressive resistance exercises) and improving movement (task-specific practice). Participant
An evidence-based therapy program is provided for 12 weeks immediately following botulinum toxin-A injection. The program commences with: (1) Up to 3 serial casts applied to place the wrist in maximum extension for 2 weeks. Cast is applied the first working day following botulinum toxin-A injection; followed by (2) 10 weeks of movement training, aimed at decreasing weakness (electrical stimulation and progressive resistance exercises) and improving movement (task-specific practice). Participants are encouraged to practice for 1 hour per day, 7 days a week during the 10 weeks (ie, approximately 70 hours in total inclusive of clinic based sessions). Participants are supported by a mix of clinic-based sessions, home visits, and phone calls. Clinic-based sessions will be conducted by a trained physical or occupational therapist (duration 1 hour, frequency decreasing (3 x per week initially, but decreasing to 1 x week by week 7)). Participants will receive a booklet outlining their movement training and a training log to record the number of minutes of practice daily.
Sponsors
La Trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Scheduled to receive a botulinum toxin-A injection to a muscle(s) that crosses the wrist - Agreed to receive BoNT-A injections as part of their usual care - Date of stroke three or more months prior. - Not currently receiving upper limb rehabilitation - Absence of significant cognitive impairment (as assessed by a score of less than five adjusted errors on the Short Portable Mental Status Questionnaire).
Exclusion criteria
- Unable to attend clinic at least 1/wk. - Other significant upper limb impairment eg. Fracture or frozen shoulder within 6 months, severe arthritis, amputation. - Presence of any and all contraindications to botulinum toxin-A injections. - Botulinum toxin-A injections and/or serial casts in the past 6 months.
Outcome results
None listed