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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643239
• Other study ID #: 94-1052B
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: February 27, 2013
• Start date: August 1996

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm
the mCIT group with individualized intervention
• Hospital-based mCIT
the mCIT group with individualized intervention
• Hospital-based TR
OT or PT or therapist-based training

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kwei-shan, Toayuan county

Sponsors (3)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Chang Gung University, National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

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