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

NCT01078766 | Unknown

• 1 other identifier: 920090440
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy; Hand Function

Keywords

cerebral palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

CIMT+HABIT

EXPERIMENTAL

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

Other: CIMT+HABIT

Interventions

CIMT+HABIT OTHER

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,

CIMT+HABIT

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alyn Pediatric & Adolescent Rehabilitation Hospital: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2010
• First Posted: March 2, 2010
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Last Updated: April 8, 2016

Record last verified: 2015-06