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

Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic CP

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.

Study Overview

• Status: Unknown
• Conditions: Cerebral Palsy; Hand Function
• Intervention / Treatment: Other: CIMT+HABIT

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisting Hand Assessment	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	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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alyn Pediatric & Adolescent Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): March 1, 2010

Study Registration Dates

• First Submitted: February 28, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (ESTIMATE): March 2, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: cerebral palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 920090440