None listed
Conditions
Brief summary
The primary objective of the project is to determine the benefit of using multiple physical modalities for treating and preventing contracture in adults with traumatic brain injury. An assessor blinded, multi-centre, randomised controlled study will be conducted. In this study, the ankle is selected as a model to asess if a multi-modality programme (tilt table standing combined with ankle splinting and electrical stimulation) is more effective than usual care (tilt table standing alone). The participants are people with traumatic brain injury admitted to the brain injury rehabilitation units of the Royal Rehabilitation Centre Sydney, Liverpool Hospital and Westmead Hospital.
Interventions
Participants in the multi-modality group will receive a 6-week programme of 30 minutes of passive standing on a tilt table plus electrical stimulation to the ankle dorsiflexors while on the tilt table, and 12 hours of ankle splinting per day, 5 times per week. Electrical stimulation will be applied using the Neuro Trac Sports stimulation unit at a frequency of 50hz. The amplitude will be set at a level to produce maximum muscle contractions within the participants' tolerance. Electrical stimulat
Participants in the multi-modality group will receive a 6-week programme of 30 minutes of passive standing on a tilt table plus electrical stimulation to the ankle dorsiflexors while on the tilt table, and 12 hours of ankle splinting per day, 5 times per week. Electrical stimulation will be applied using the Neuro Trac Sports stimulation unit at a frequency of 50hz. The amplitude will be set at a level to produce maximum muscle contractions within the participants' tolerance. Electrical stimulation will not be used on participants who have contraindications (ie., rate controlled cardiac pacemaker and broken skin) or are unable to tolerate even the smallest amount of simulation. Commercially available splint (Formit) will be used to splint ankles. The ankles will be splinted in maximum tolerable dorsiflexion. The splints will generally be worn at night however this can be varied to minimise interference with hygiene and therapy. Different splints can be used if there are problems with the Formit and care sill be taken to ensure that they provide adequate stretch.
Sponsors
Royal Rehabilitation Centre Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Diagnosed with first traumatic brain injury -Unable to walk 17 metres without physical assistance or 50 metres with supervision, ie., a score of <5 on the walking item of the Functional Independence Measure -Have passive ankle dorsflexion range of motion <5 and >-15 degrees with the application of 12Nm of torque -Willing and able to participate in a splinting regimen and tilt table standing -Do not have unstable medical conditions or recent ankle fractures -Currently receiving in-patient rehabilitation at the three brain injury units in Sydney -Unlikely to be discharged in 6 weeks -Provide consent to participate in the study (the participants or the person responsible for them)
Exclusion criteria
-Passive ankle dorsiflexion range of motion >5 degrees -Severe ankle contracture with passive ankle dorsiflexion range of motion <-15 degrees -Unstable medical conditions or recent ankle fractures
Outcome results
None listed