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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01078766
• Other study ID #: 920090440
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 28, 2010
• Last updated: April 7, 2016
• Start date: August 2009

Study information

• Verified date: June 2015
• Source: Alyn Pediatric & Adolecent Rehabilitation Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 9
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 9 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hand Function

Intervention

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,

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alyn Pediatric & Adolecent Rehabilitation Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No