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

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm; Other: Hospital-based mCIT; Other: Hospital-based TR

• Registration Number: NCT01643239
• Lead Sponsor: Chang Gung Memorial Hospital

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.

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 Timeline

• Study Start: 1996-08
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Primary Completion: 2012-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hospital-based mCIT with individualized intervention	Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm	Hospital-based modified constraint-induced therapy(mCIT)
Hospital-based mCIT with group therapy	Hospital-based mCIT	Hospital-based modified constraint-induced therapy(mCIT)
Hospital-based TR	Hospital-based TR	Hospital-based traditional rehabilitation (TR)

Primary Outcome Measures

Name	Time	Method
Kinematic assessment	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

Name	Time	Method
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)	up to six years	The clinical tools used in this study measure the intervention impact on bimanual coordination and unilateral performance of upper extremity.

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kwei-shan, Toayuan county, Taiwan