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Completed

NCT Number: NCT01643239

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

the mCIT group with individualized intervention

Other names: Hospital-based modified constraint-induced therapy(mCIT)

Hospital-based mCIT

Other

the mCIT group with individualized intervention

Other names: Hospital-based modified constraint-induced therapy(mCIT)

Hospital-based TR

Other

OT or PT or therapist-based training

Other names: Hospital-based traditional rehabilitation (TR)

Primary outcomes

  1. Kinematic assessment

    Time frame: 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 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)

    Time frame: up to six years

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

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Chang Gung University
  • National Science and Technology Council, Taiwan

Registry information

Official study 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

Important dates

Study start
1996
Primary completion
2012
First posted
Jul 18, 2012
Registry last updated
Feb 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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