ACTRN12615000821594.

Trial name or title	Effectiveness of Combining Serial Casting and Botulinum Toxin for the Management of Ankle Contractures after Traumatic Brain Injury: a Randomised Controlled Study.
Methods	Randomised controlled trial (2 arms, with cross‐over). Setting: Brain Injury Unit, Sydney, Australia. Funding: Royal Rehab Foundation (charitable).
Participants	Total participants: 10 (anticipated). Age range: 18‐85 years. Inclusion criteria: diagnosed with first TBI; 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 provides consent to participate in the study (the participants or the person legally responsible for them). Exclusion criteria: unstable medical conditions or recent ankle fracture; within 3 months after receiving botulinum toxin; severe ankle varus or knee/hip flexion contractures (which affects the reliability of measuring ankle dorsiflexion). Location of spasticity: Calf muscles/ankle. Specific muscles that may be treated include soleus, gastrocnemius, flexor hallucis longer and flexor digitorium longus and tibialis posterior where necessary.
Interventions	Botulinum toxin and serial casting: ≥ 1 botulinum toxin injections into calf muscles (dose dependent on number of muscles needing injection, but not in excess of 400 mL). Serial casting with be commenced within a few days (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. Participants will receive usual care as well (see usual care). Usual care: placed on a wait list for 6 weeks during which they receive no botulinum toxin, splinting and passive stretch‐based interventions for the ankle. Usual care includes multidisciplinary rehabilitation provided by the unit as appropriate. This consisted of physiotherapy, occupational therapy, speech therapy, recreational therapy and psychological therapy. Physiotherapy included an individualised motor training programme which might involve lower limb exercises, practice of sit to stand, standing and walking. Also involves positioning of participants' feet in dorsiflexion while seated and lying.
Outcomes	Primary outcome: Passive dorsiflexion range at a standardised torque, measured within 3 days after completion of serial casting. Secondary outcomes: Spasticity of ankle plantarflexors (Tardieu Scale score and Modified Ashworth Scale score), measured within 3 days after completion of serial casting; FIM Walking score and 10‐m walk test, measured within 3 days after completion of serial casting; therapist questionnaire (perceived effectiveness, adverse events and treatment worth), designed specifically for study.
Starting date	1 July 2015 (date of first participant enrolment).
Contact information	Dr Joan Wai King Leung, Brain Injury Unit, Royal Rehab, Ryde, NSW. Email: joan.leung@royalrehab.com.au.
Notes	Anticipated end date (as per clinical trials entry last updated in 13 July 2016): 1 September 2018. Note that spasticity is not an inclusion criterion, but as per the other study by this investigator (Leung 2014), spasticity is being measured at baseline, and is an outcome. In future updates, the review author team will contact the lead investigator to determine how many of the participants had spasticity at baseline to therefore confirm it meets the inclusion criteria for the review.

FIM: Functional Independence Measure; TBI: traumatic brain injury.