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A Trial Comparing Two Methods of CIMT in the Hemiplegic Child

NCT01770678 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-01-18

No results posted yet for this study

Summary

Cerebral palsy remains a major cause of lifelong disability affecting approximately 2 per 1,000 children. Of those about 30% have hemiplegic cerebral palsy (HPC),a unilateral impairment, which can often lead to major difficulties with manual dexterity and upper limb,functional ability and independence. Therapists employ a number of strategies in upper limb rehabilitation however they are poorly understood and their efficacy has been questioned. Constraint induced movement therapy (CIMT)has been found to be an effective intervention with HCP however its use in the preschool child within a national health service (NHS) setting has not been evaluated. The investigators aim is to compare CIMT using prolonged restraint with CIMT using brief manual restraint which may be standard practice and acts as the control. This age group has been targeted as there may be greatest neural plasticity (change)and minimal disruption to compulsory education. The investigators intend to recruit 60 patients from treatment databases of participating trusts. Patients will be randomised following baseline assessments which will include 2 upper limb assessments(The Assisting Hand Assessment and the Quality of Upper Extremity Skills Test) and a quality of life questionnaire (PedsQL Generic Core Scales and the Cerebral Palsy Module) for parents. The intervention period will be for 6 weeks offered intermittently (2week blocks) over 10 weeks. Parents /guardians and possibly preschool workers will be expected to carry out a therapy guided programme. The amount of intervention and compliance will be recorded by parents/guardians and therapists. Assessments will be repeated at 10 weeks and 24 weeks from the beginning of the trial. The results of the trial will contribute to the evidence on the effectiveness of CIMT in the preschool child with HCP, and will also provide evidence on the implementation of CIMT delivery within the current NHS therapy services.

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Conditions

  • Cerebral Palsy

Interventions

OTHER

Constraint Induced Movement Therapy

A combination of prolonged restraint of the unaffected upper limb and massed practice of the affected upper limb.

Sponsors & Collaborators

  • University of Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770678 on ClinicalTrials.gov