None listed
Conditions
Brief summary
This randomsied comparison trial will test the efficiacy of a novel rehabilitation (constraint induced movement therapy) whcih involves placing a glove on the unimpaired hand and intensively training the Hemiplegic hand and comparing this approach to more conventional bimanaul training in children with congenital hemiplegia.
Interventions
Constraint Induced movement therapy involves use of tailor made glove like splint worn on the unimpaired (dominant writting hand) and intensive activity based practice activities encouraging active use and manipulation with the other impaired (hemiplegic hand). Participants in the CIMT group will wear a tailor made glove on their unimpaired limb while attending the day camp, which will only be removed for toileting. The training occurs for 6 hours per day over 10 days for a total dose of 60 hour
Constraint Induced movement therapy involves use of tailor made glove like splint worn on the unimpaired (dominant writting hand) and intensive activity based practice activities encouraging active use and manipulation with the other impaired (hemiplegic hand). Participants in the CIMT group will wear a tailor made glove on their unimpaired limb while attending the day camp, which will only be removed for toileting. The training occurs for 6 hours per day over 10 days for a total dose of 60 hours, with one trainer per two participants, in a comunity recreation facility.
Sponsors
National Health and Medical Research Insitute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria The study will include children and youth: 1. With a confirmed diagnosis of congenital hemiplegia. 2. Aged 5 to 16 years. 3. With predominant spasticity rather than dystonia interfering with upper limb function according to the classification of motor type by Sanger et al[31] with Modified Ashworth Scale grade >1 but <3.[32] 4. Ability to achieve minimal active grasp with the impaired hand. 5. Sufficient co-operation and cognitive understanding to participate in the group activities. For a subset of children performing the Advanced Brain Imaging and Transcranial Magnetic Stimulation (TMS) studies further inclusion criteria are:- 1. Sufficient co-operation to perform Advanced Brain Imaging studies for 45 minutes. 2. No exclusions for 3 tesla Magnetic Resonance Imaging (3T MRI) including no metal implants, no shunts, no uncontrolled epilepsy as the later would be a confound. 3. For TMS there must be no current or previous history of epilepsy.
Exclusion criteria
1. Severe muscle spasticity and/or contracture on the Modified Ashworth Scale(MAS > grade 3, i.e. muscle contracture or rigidity) which would require spasticity management or serial casting. 2. Previous orthopaedic surgery in the upper limb. 3. Serial casting or Botulinum Toxin A (BoNT-A) injections in the upper limb within 6 months prior to study entry.
Outcome results
None listed