NCT01643239

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
15.9 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

16.1 years

First QC Date

July 4, 2012

Last Update Submit

February 27, 2013

Conditions

Cerebral Palsy

Keywords

Modified constraint-induced therapyChildren with cerebral palsyKinematic analysisGroup therapy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (3)

Hospital-based mCIT with individualized intervention

EXPERIMENTAL

Hospital-based modified constraint-induced therapy(mCIT)

Other: Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm

Hospital-based mCIT with group therapy

EXPERIMENTAL

Hospital-based modified constraint-induced therapy(mCIT)

Other: Hospital-based mCIT

Hospital-based TR

OTHER

Hospital-based traditional rehabilitation (TR)

Other: Hospital-based TR

Interventions

Hospital-based mCIT restraint of the unaffected arm and practice of the affected armOTHER

the mCIT group with individualized intervention

Also known as: Hospital-based modified constraint-induced therapy(mCIT)
Hospital-based mCIT with individualized intervention
Hospital-based mCITOTHER

the mCIT group with individualized intervention

Also known as: Hospital-based modified constraint-induced therapy(mCIT)
Hospital-based mCIT with group therapy
Hospital-based TROTHER

OT or PT or therapist-based training

Also known as: Hospital-based traditional rehabilitation (TR)
Hospital-based TR

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ching-yi Wu, ScD

    Department of Occupational Therapy, Chang Gung Univ.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 18, 2012

Study Start

August 1, 1996

Primary Completion

September 1, 2012

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

TW(1)