Text Size

Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy

This study has been completed.
Sponsor:
Collaborators:
Chang Gung University
National Science Council, Taiwan
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01643239
First received: July 4, 2012
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mCIT) on the more affected upper extremity of children with cerebral palsy.


Condition Intervention
Cerebral Palsy
 Other: Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm
Other: Hospital-based mCIT
Other: Hospital-based TR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Effects of Forms of Modified Constraint-induced Therapy on Functional Performance of Upper Extremity in Children With Cerebral Palsy With Asymmetric Motor Impairments: A Follow up Study of Kinematic and Clinical Analyses

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Kinematic assessment [ Time Frame: up to six years ] [ Designated as safety issue: Yes ]
    An analysis program coded by LabVIEW (National Instruments, Inc., Austin, TX) language was used to process the kinematic data. The variables of reaction time (sec), normalized movement time (sec/mm), normalized total displacement (unit), joint ranges recruitment (normalized shoulder flexion angle, normalized elbow flexion; degree/mm) angle, and normalized maximum shoulder abduction angle), and maximum shoulder and elbow cross correlation were collected.


Secondary Outcome Measures:
  • Clinical measures at the motor quality and performance include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP), and Peabody-Developmental Motor Scales (PDMS-II) [ Time Frame: up to six years ] [ Designated as safety issue: Yes ]
    The clinical tools used in this study measure the intervention impact on bimanual coordination and unilateral performance of upper extremity.


Enrollment: 60
Study Start Date: August 1996
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hospital-based mCIT with individualized intervention
Hospital-based modified constraint-induced therapy(mCIT)
 Other: Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm
the mCIT group with individualized intervention
Other Name: Hospital-based modified constraint-induced therapy(mCIT)
Experimental: Hospital-based mCIT with group therapy
Hospital-based modified constraint-induced therapy(mCIT)
 Other: Hospital-based mCIT
the mCIT group with individualized intervention
Other Name: Hospital-based modified constraint-induced therapy(mCIT)
Hospital-based TR
Hospital-based traditional rehabilitation (TR)
 Other: Hospital-based TR
OT or PT or therapist-based training
Other Name: Hospital-based traditional rehabilitation (TR)

Detailed Description:

The study included threefold: (1) It will employ kinematic analysis, along with clinical assessment tools to examine the effects of mCIT on the more affected upper extremity of children with cerebral palsy with asymmetric motor impairments after treatment immediately and 1 year following. The clinical tools will include Motor Activity Log (MAL), Bruininks-Oseretsky Test of Motor Proficiency (BOTMP),Peabody-Developmental Motor Scales (PDMS-II), and Wee-FIM. (2) This study looked at the intervention impact on bimanual coordination and the less affected upper extremity. (3) It investigated the effects of forms (group vs. individual intervention) on upper extremity performance.

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. clinical diagnosis of spastic CP
  2. age between 4 and 10 years old
  3. shoulder flexion of the affected upper limb more than 90 degrees, elbow extension over 160 degrees, wrist extension to 10 degrees at least, and fingers full flexion to 10 degrees at least
  4. basic balance ability: sitting on the chair without arm support; feet stay on the floor consistently; performing the affected upper limb movement without losing balance
  5. ability to follow simple oral commands
  6. no related musculoskeletal surgery of the affected upper limb
  7. not have injected the Botox into the affected upper extremity during the past 6 months
  8. no visual or auditory disability
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643239

Locations
Taiwan
Chang Gung Memorial Hospital
Kwei-shan, Toayuan county, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Chang Gung University
National Science Council, Taiwan
Investigators
Principal Investigator: Ching-yi Wu, ScD Department of Occupational Therapy, Chang Gung Univ.
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01643239     History of Changes
Other Study ID Numbers: 94-1052B
Study First Received: July 4, 2012
Last Updated: February 27, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Modified constraint-induced therapy
Children with cerebral palsy
Kinematic analysis
Group therapy

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