None listed
Conditions
Brief summary
The primary objective of the project is to determine the effectiveness of a treatment program combining serial casting with Botulinum Toxin for the management of contractures in adults with acquired brain injury. An assessor blinded, randomised controlled study with a cross-over design will be conducted. Ankle joint is selected as a model to assess the effectiveness of the intervention. Participants will be adults with acquired brain injury admitted to the Brain Injury Rehabilitation Unit of Royal Rehab for sub-acute rehabilitation. Between-group comparisons will be made to determine the effectiveness of the intervention program. The participants in the control group will be placed on a wait list for the same treatment program. Pre-and post-intervention comparisons will also be made within the control group. Follow-up assessments for both the experimental group and control group will be conducted 8 weeks post interventions, at discharge and if possible 1 year after discharge to assess the long-term effects of the interventions.
Interventions
The intervention group receives intervention treatment in addition to usual care. Botulinum toxin will be injected into calf muscles which may include soleus, gastronemius, flexor hallucis longer and flexor digitorium longus. Botulinum toxin injection may also be injected into tibialis posterior where necessary. The injections will be administered by a sole person (the Director of the Brain Injury Unit) with electrical stimulation or sonographic guidance. The dose of botulinum toxin will vary de
The intervention group receives intervention treatment in addition to usual care. Botulinum toxin will be injected into calf muscles which may include soleus, gastronemius, flexor hallucis longer and flexor digitorium longus. Botulinum toxin injection may also be injected into tibialis posterior where necessary. The injections will be administered by a sole person (the Director of the Brain Injury Unit) with electrical stimulation or sonographic guidance. The dose of botulinum toxin will vary depending on number of muscles needing injections but will be within the recommended maximum dose of 400ml. Serial casting will be commenced within a few days. Cast will be applied to the ankle by physiotherapists. The duration of casting and number of cast applied may vary based on the participants’ responses to casting. After completion of casting, a customised ankle splint will be used immediately. The splint will be worn 24 hours a day for the initial 2 weeks during which the splint will only be removed for hygiene reasons and therapy. Thereafter ongoing monitoring will be conducted and the splinting time will be maintained or reduced depending on the progress of the participants. The splint will be applied by physiotherapists, nursing staff or physiotherapy assistants as directed by the treating physiotherapists. The participants’ tolerance to splinting and skin condition will be closely monitored. This treatment program simulates the current clinical practice of a Brain Injury Unit in Sydney. Participants in the control group will be placed on a wait list for 6 weeks during which they receive no botulinum toxin, splinting and passive stretch-based interventions for the ankle. Thereafter, they receive the same treatment as the intervention group. Diaries will be used to record all interventions and adverse events.
Sponsors
Royal Rehab
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 85 Years
Healthy volunteers
No
Inclusion criteria
-diagnosed with acquired brain injury and admitted for sub-acute rehabilitation -presents with an ankle contracture of a severe degree -able to receive botulinum toxin injections and serial casting -unlikely to be discharged in 12 weeks, and -provide consent to participate in the study (the participants or the person legally responsible for them (This person can be legal guardian/next of kin or carer as determined by law)
Exclusion criteria
-unstable medical conditions or recent ankle fractures -within 3 months after receiving botulinum toxin -severe ankle varus or knee/hip flexion contractures (which affects the reliability of measuring ankle dorsiflexion)
Outcome results
None listed