Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic Cerebral Palsy (CP)

Sponsor
Alyn Pediatric & Adolescent Rehabilitation Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01078766
Collaborator
(none)
9
1

Study Details

Study Description

Brief Summary

The combination of the constraint-induced movement therapy (CIMT) method as a complement to hand arm bimanual training (HABIT) will improve the frequency and quality of cooperative hand use and function in children with hemiplegic CP.

Condition or Disease Intervention/Treatment Phase
  • Other: CIMT+HABIT
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic CP
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Mar 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: CIMT+HABIT

Form of "summer camp", for six hours per day for 10 consecutive work days.

Other: CIMT+HABIT
The daily schedule included one hour of constraining the functional arm with intensive activation of the hemi-paretic arm and then 5 hours of various structured, intensive bimanual functional activities,

Outcome Measures

Primary Outcome Measures

  1. Assisting Hand Assessment [twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program]

    Rasch built, it measures how effectively a child with unilateral disability typically makes use of their affected (assisting) hand during bimanual performance. It is conducted by a semi-structured play session requiring bimanual handling that is video-recorded. Scoring is performed by a analyzing the video on 22 predefined items using a 4-point criterion-referenced rating scale

Secondary Outcome Measures

  1. Jebsen-Taylor Test of Hand Function [twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program]

  2. The Pediatric Evaluation of Disability Inventory (PEDI) [twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program]

  3. Muscle strength [twice before the intervention: one month and two days before as control period, and three times after the intervention: within the last two days, two months and six months after the end of the intervention program]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • active wrist extension/dorsiflexion of at least 20;

  • MACS 1-3;

  • GMFCS 1-2;

  • enrolled in regular or remedial level education with ability to understand instructions and participate without parent presence.

Exclusion criteria:
  • seizures;

  • severely increased muscle tone; or hemi arm to good;

  • orthopedic surgery on the upper extremity;

  • botulin toxin injections within the past half year to the upper extremity;

  • inability to understand instructions or cognitive/behavior/concentration.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Alyn Pediatric & Adolescent Rehabilitation Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alyn Pediatric & Adolescent Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01078766
Other Study ID Numbers:
  • 920090440
First Posted:
Mar 2, 2010
Last Update Posted:
Apr 8, 2016
Last Verified:
Jun 1, 2015
Keywords provided by Alyn Pediatric & Adolescent Rehabilitation Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2016