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

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ClinicalTrials.gov Identifier: NCT01078766
Recruitment Status : Unknown
Verified June 2015 by Alyn Pediatric & Adolecent Rehabilitation Center.
Recruitment status was:  Enrolling by invitation
First Posted : March 2, 2010
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Alyn Pediatric & Adolecent Rehabilitation Center

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Hand Function Other: CIMT+HABIT Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Constraint-induced Movement Therapy and Hand Arm Bimanual Training in Children With Hemiplegic CP
Study Start Date : August 2009
Actual Primary Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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,



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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.

Responsible Party: Alyn Pediatric & Adolecent Rehabilitation Center
ClinicalTrials.gov Identifier: NCT01078766     History of Changes
Other Study ID Numbers: 920090440
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: June 2015

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

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases