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

Not Applicable

• Conditions: Hand Function; Cerebral Palsy
• Interventions: Other: CIMT+HABIT

• Registration Number: NCT01078766
• Lead Sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-02-28
• Primary Completion: 2010-03
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Status Verified: 2015-06
• Last Update Submitted: 2016-04-07
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CIMT+HABIT	CIMT+HABIT	Form of "summer camp", for six hours per day for 10 consecutive work days.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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