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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Alyn Pediatric & Adolecent Rehabilitation Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Alyn Pediatric & Adolecent Rehabilitation Center
ClinicalTrials.gov Identifier:
NCT01078766
First received: February 28, 2010
Last updated: July 9, 2012
Last verified: August 2009
History of Changes
  Purpose

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 Intervention
Cerebral Palsy
Hand Function
 Other: CIMT+HABIT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic CP

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alyn Pediatric & Adolecent Rehabilitation Center:

Primary Outcome Measures:
  • Assisting Hand Assessment [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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:
  • Jebsen-Taylor Test of Hand Function [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • The Pediatric Evaluation of Disability Inventory (PEDI) [ Time Frame: 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 ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: 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 ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: August 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

  Eligibility

Ages Eligible for Study:   6 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alyn Pediatric & Adolecent Rehabilitation Center
ClinicalTrials.gov Identifier: NCT01078766     History of Changes
Other Study ID Numbers: 920090440
Study First Received: February 28, 2010
Last Updated: July 9, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Alyn Pediatric & Adolecent Rehabilitation Center:
cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013