Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy - Full Text View

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:

MedlinePlus related topics: Cerebral Palsy Health Facilities Paralysis

Genetic and Rare Diseases Information Center resources: Cerebral Palsy

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 (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

clinical diagnosis of spastic CP
age between 4 and 10 years old
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
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
ability to follow simple oral commands
no related musculoskeletal surgery of the affected upper limb
not have injected the Botox into the affected upper extremity during the past 6 months
no visual or auditory disability

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 23, 2016