A randomised clinical trial to determine the relative benefits of botulinum toxin injections, ankle foot orthosis or a combination of both on knee hyperextension during walking in people with chronic stroke.

There are 3 proposed interventions: Botulinum toxin alone, botulinum toxin with ankle foot orthosis, and ankle foot orthosis with normal saline. Botulinum toxin A (BoNT-A) is a neuromuscular blocking agent. When injected it produces a localised partial but reversible chemical denervation of the muscle, resulting in localised muscle paralysis. This effect is temporary. The ankle foot orthosis (AFO) to be used is a rigid moulded splint that goes around the ankle and comes up the front of the shin and over the top of the knee cap. The splint is used to control the foot position and cause pressure at the knee to realign it. There is reinforcement at the ankle to strengthen the splint. Participants will be randomised to one of three intervention groups (5 people in each group.) All participants will attend a clinic within Southern Health and receive a single dose intra-muscular injection of either 200U BoNT-A or normal saline (100 ml of 9% sodium chloride) - 10 people will receive BoNT-A and 5 people will receive normal saline. The injections will be given by a medical specialist experienced in the use of intra-muscular BoNT-A. The 10 persons receiving an AFO will attend an orthotist for casting and fitting of the AFO (2-3 x visits required) prior to injection. They will commence wearing the AFO the day following the injection. The participants will be instructed to gradually wear in the AFO. It is usual to start with wearing the splint for one or two hours on the first day. Each consecutive day one hour or wear is added (first day of wear for 2 hours, second day of wear for 3 hours, third day of wear for 4 hours etc.) After two weeks the AFO should be able to be worn full time. Participants will be instructed to continue wearing the splint daily until all assessments have been completed (at least 12 weeks). Following injection all participants will receive 6 weeks of twice weekly gait re-education conducted by physiotherapists experienced in the management of stroke.