Cerebral Palsy Clinical Trial
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
NCT number | NCT01643239 |
Other study ID # | 94-1052B |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | July 4, 2012 |
Last updated | February 27, 2013 |
Start date | August 1996 |
Verified date | February 2013 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 10 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Kwei-shan, Toayuan county |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital | Chang Gung University, National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | up to six years | Yes |
Secondary | 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. | up to six years | Yes |
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