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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
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	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
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
Study Start Date :	August 1996
Actual Primary Completion Date :	September 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. Kinematic assessment [ Time Frame: up to six years ]
   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 :

1. 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 ]
   The clinical tools used in this study measure the intervention impact on bimanual coordination and unilateral performance of upper extremity.

Eligibility Criteria

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Ages Eligible for Study:	4 Years to 10 Years (Child)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01643239 History of Changes
Other Study ID Numbers:	94-1052B
First Posted:	July 18, 2012
Last Update Posted:	February 28, 2013
Last Verified:	February 2013

Keywords provided by Chang Gung Memorial Hospital:

Modified constraint-induced therapy; Children with cerebral palsy; Kinematic analysis; Group therapy

Additional relevant MeSH terms:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases	Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases