A Trial Comparing Two Methods of CIMT in the Hemiplegic Child

NCT01770678 | Completed Phase 2

• 1 other identifier: Sophieis17
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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. .

Conditions

Cerebral Palsy

Keywords

Children; Cerebral Palsy; Randomised; Constraint Induced Movement Therapy

Outcome Measures

Primary Outcomes (1)

• The Assisting Hand Assessment

  The Assisting Hand Assessment (AHA) (Krumlinde-Sundholm et al 2007) measures and describes the effectiveness with which a child with unilateral disability makes use of their affected hand in bimanual activity.It is a well evaluated measure appropriate for hand function in hemiplegia.

  10 weeks after the intervention begins

Secondary Outcomes (1)

• Quality of Upper Extremity Skills Test

  10 weeks and 24 weeks after the intervention begins

Study Arms (2)

Constraint induced movement therapy (prolonged restraint)

EXPERIMENTAL

Constraint induced movement therapy(prolonged restraint)consists of a combination of prolonged restraint of the unaffected upper limb and massed practice of the affected upper limb over a forty-two day period.

Other: Constraint Induced Movement Therapy

Constraint induced movement therapy(manual restraint)

ACTIVE COMPARATOR

Constraint induced movement therapy(manual restraint)consists of a combination of manual restraint of the unaffected upper limb and massed practice of the affected upper limb over a forty-two day period.

Other: Constraint Induced Movement Therapy

Interventions

Constraint Induced Movement Therapy OTHER

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

Constraint induced movement therapy (prolonged restraint); Constraint induced movement therapy(manual restraint)

Eligibility Criteria

• Age: 18 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of hemiplegic cerebral palsy
• Aged between 18 months and 4 years(9 months before compulsory education begins).

You may not qualify if:

• Diagnosis/ clinical evidence of bilateral upper limb involvement.
• Diagnosis/ clinical evidence of athetosis or dystonia.
• Any medical condition which would cause problems with the cast e.g. chronic eczema.
• An episode of \>2 weeks of prolonged CIMT using a cast /splint in the previous 6 months.

Sponsors & Collaborators

• University of Birmingham: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physiotherapist

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: January 18, 2013
• Study Start: August 1, 2010
• Primary Completion: April 1, 2012
• Last Updated: January 18, 2013

Record last verified: 2012-06