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COMBiT- A randomised trial of combined constraint induced movement therapy and bimanual training in hemiplegia

COMBiT- randomised trial comparing combined constraint induced movement therapy and bimanual upper limb training to standard care consisting of an individualised therapy program for children with hemiplegia.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000181707
Acronym
COMBiT
Enrollment
50
Registered
2013-02-15
Start date
2011-09-01
Completion date
2014-09-05
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research project will compare a new intensive upper limb rehabilitation approach (COMBiT- combined constraint induced movement therapy and bimanual therapy) with standard care individual occupational therapy for children with congenital hemiplegia.

Interventions

COMBiT is an intensive group based day program combining two theoretically different interventions: constraint induced movement therapy (CIMT) and bimanual upper limb training (BIM). CIMT upper limb training involves restraining the unimpaired limb using an individually tailored 'glove'combined with intense practice of tasks with the impaired limb during attendance at day camp. CIMT is performed first for 6 hours/day for 5 days=30 hours. This is followed by BIM which is based on motor learning a

COMBiT is an intensive group based day program combining two theoretically different interventions: constraint induced movement therapy (CIMT) and bimanual upper limb training (BIM). CIMT upper limb training involves restraining the unimpaired limb using an individually tailored 'glove'combined with intense practice of tasks with the impaired limb during attendance at day camp. CIMT is performed first for 6 hours/day for 5 days=30 hours. This is followed by BIM which is based on motor learning and requires individualised 2 handed activities. This will be performed in the second week 6 hours/day for 5 day=30 hours. COMBiT will use a circus based theme for the day camp. The CIMT and BIM interventions will be conducted in a group based format faciliated by experienced occupational therapists and circus trainers.

Sponsors

National Health and Medical Research Council
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
5 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

Participants will have reduced upper limb (UL) function due to predominant spasticity rather than dystonia, and sufficient cognitive capacity to follow instructions and participate in the UL intervention. The study will include school aged children and youth: 1. Confirmed diagnosis of congential hemiplegia 2. Aged 5-16 years 3. Reduced upper limb function due to predominant spasticity rather than dystonia 4. Sufficient cooperation and cognitive understanding to particiapte in the therapy activities.

Exclusion criteria

Participants will be excluded if they have: 1. Fixed contracture or severe muscle spasticity in the designated muscle groups 2. Previously undergone surgery in the UL 3. Received BoNT-A injections within 6 weeks prior to baseline assessments.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 23, 2026