A Trial Comparing Two Methods of CIMT in the Hemiplegic Child (HCPCIMT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pauline Christmas, University of Birmingham
ClinicalTrials.gov Identifier:
NCT01770678
First received: June 19, 2012
Last updated: January 17, 2013
Last verified: June 2012
  Purpose

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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Condition Intervention Phase
Cerebral Palsy
Other: Constraint Induced Movement Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Compare Two Methods of Constraint Induced Movement Therapy to Improve Functional Ability in the Affected Upper Limb in Pre-school Children With Hemiplegic Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • The Assisting Hand Assessment [ Time Frame: 10 weeks after the intervention begins ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of Upper Extremity Skills Test [ Time Frame: 10 weeks and 24 weeks after the intervention begins ] [ Designated as safety issue: No ]
    Quality of Upper Extremity Skills Test


Enrollment: 62
Study Start Date: August 2010
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Constraint induced movement therapy (prolonged restraint)
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
A combination of prolonged restraint of the unaffected upper limb and massed practice of the affected upper limb.
Active Comparator: Constraint induced movement therapy(manual restraint)
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
A combination of prolonged restraint of the unaffected upper limb and massed practice of the affected upper limb.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Months to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Pauline Christmas, Consultant Physiotherapist, University of Birmingham
ClinicalTrials.gov Identifier: NCT01770678     History of Changes
Other Study ID Numbers: Sophieis17
Study First Received: June 19, 2012
Last Updated: January 17, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Birmingham:
Children
Cerebral Palsy
Randomised
Constraint Induced Movement Therapy

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014