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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm
Hospital-based mCIT
Hospital-based TR
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Modified constraint-induced therapy, Children with cerebral palsy, Kinematic analysis, Group therapy

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Hospital-based mCIT with individualized intervention

Hospital-based mCIT with group therapy

Hospital-based TR

Arm Description

Hospital-based modified constraint-induced therapy(mCIT)

Hospital-based modified constraint-induced therapy(mCIT)

Hospital-based traditional rehabilitation (TR)

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 4, 2012
Last Updated
February 27, 2013
Sponsor
Chang Gung Memorial Hospital
Collaborators
Chang Gung University, National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01643239
Brief Title
Effects of Forms of Modified CIT on Upper Extremity Performance in Cerebral Palsy
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Chang Gung University, National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Modified constraint-induced therapy, Children with cerebral palsy, Kinematic analysis, Group therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospital-based mCIT with individualized intervention
Arm Type
Experimental
Arm Description
Hospital-based modified constraint-induced therapy(mCIT)
Arm Title
Hospital-based mCIT with group therapy
Arm Type
Experimental
Arm Description
Hospital-based modified constraint-induced therapy(mCIT)
Arm Title
Hospital-based TR
Arm Type
Other
Arm Description
Hospital-based traditional rehabilitation (TR)
Intervention Type
Other
Intervention Name(s)
Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm
Other Intervention Name(s)
Hospital-based modified constraint-induced therapy(mCIT)
Intervention Description
the mCIT group with individualized intervention
Intervention Type
Other
Intervention Name(s)
Hospital-based mCIT
Other Intervention Name(s)
Hospital-based modified constraint-induced therapy(mCIT)
Intervention Description
the mCIT group with individualized intervention
Intervention Type
Other
Intervention Name(s)
Hospital-based TR
Other Intervention Name(s)
Hospital-based traditional rehabilitation (TR)
Intervention Description
OT or PT or therapist-based training
Primary Outcome Measure Information:
Title
Kinematic assessment
Description
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.
Time Frame
up to six years
Secondary Outcome Measure Information:
Title
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)
Description
The clinical tools used in this study measure the intervention impact on bimanual coordination and unilateral performance of upper extremity.
Time Frame
up to six years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-yi Wu, ScD
Organizational Affiliation
Department of Occupational Therapy, Chang Gung Univ.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kwei-shan, Toayuan county
Country
Taiwan

12. IPD Sharing Statement

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

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