Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Constraint-induced Movement Therapy and Self-regulation for Children With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957708
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Collaborator:
The Hong Kong Polytechnic University
Information provided by (Responsible Party):
Karen Liu, University of Western Sydney

Brief Summary:
This study examines the effect of combining modified constraint-induced movement therapy (mCIMT) and self-regulation (SR) in promoting upper limb function of children with hemiplegic cerebral palsy (CP) studying in a school-based setting.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: mCIMT + SR Other: Control Not Applicable

Detailed Description:

Children diagnosed with hemiplegic CP are involved. A within-subject design is used with children acting as their own controls. The study is scheduled at three-week intervals. All children undergo conventional occupational therapy (OT) and modified constraint-induced movement therapy plus self-regulation (mCIMT + SR) program in a random order.

Both programs last for three weeks. Each program is followed by a three-week no-treatment period to measure the carry-over effect. The OT program consists of training on unimanual and bimanual tasks for 1 to 2 hours a week with daily home exercise. The mCIMT + SR program involves restraint of the unaffected upper limb of children using a cotton sling for 6 hours per day for 15 days. A one-hour structured task practice with the use of SR is provided during each 6-hour restraint.

The Bruininks-Oseretsky Test of Motor Proficiency, the Jebsen-Taylor Test of Hand Function, the Caregiver Functional Use Survey, a hand dynamometer, pinch gauge, and modified Ashworth scale are used for evaluation. All children are assessed for five times at 3-week interval: once before and twice after the conventional OT; and twice after the mCIMT + SR at 1 week and at 3 weeks.

Before and after the three-week intervention, the children participate in event-related potentials (ERP) sessions with a choice reaction task. Event-related potentials (ERP) technique is used to capture the changes in neural mechanism after intervention.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Modified Constraint-induced Movement Therapy and Self-regulation Learning for Children With Hemiplegic Cerebral Palsy
Study Start Date : December 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mCIMT + SR
modified constraint-induced movement therapy plus self regulation
Other: mCIMT + SR

Each participant wears a customized cotton sling on the unaffected arm for six hours everyday. Participant is engaged in fifteen unimanual tasks during the three-week training that provides them sufficient challenge and opportunities for repetition.

SR is incorporated on the 1-hour structured practice by using video playback to help participants realize their own performance for better learning. Participant first performs a task with videotaping, then identifies steps with problems or difficulties by video playback of participant's performance. Secondly, participant is asked for possible solutions, prompting is given if needed. Lastly, participant performs the activity by adopting the suggested solutions with videotaping again to facilitate participant's evaluation of new performance.


Active Comparator: Control
conventional occupational therapy
Other: Control
A combination of training on functional and remedial activities on unimanual tasks and bimanual tasks that based primarily on neurodevelopmental approach are provided. The training aims at increasing control, strength and functional use of their affected arm and hand, and improving bimanual coordination in performing daily activities. Each participant receives 1 to 2 hours of training per week at school. Home exercise including both unimanual and bimanual tasks is prescribed to them as well.
Other Name: Conventional occupational therapy




Primary Outcome Measures :
  1. Change in Bruininks-Oseretsky Test of Motor Proficiency [ Time Frame: Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) ]

    Subtest 5 ((upper-limb coordination) and subtext 8 (speed and dexterity), testing the upper limb function are used.

    Time frame:

    Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)


  2. Change in Jebsen-Taylor Test of Hand Funcion [ Time Frame: Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) ]

    It assesses hand function using seven unimanual tasks: writing, turning cards over, picking up small commonly encountered objects, simulated eating, stacking checker, and moving light and heavy cans.

    Time frame:

    Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)



Secondary Outcome Measures :
  1. Change in Caregiver Functional Use Survey [ Time Frame: Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) ]

    It reviews caregivers' perceptions of how much and how well their child use the affected upper limb in the real-life situation.

    Time frame:

    Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)


  2. Change in Grip strength [ Time Frame: Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) ]

    It is measured using a Jamar hand dynamometer.

    Time frame:

    Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)


  3. Change in Pinch strength [ Time Frame: Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) ]

    It is measured using a pinch gauge.

    Time frame:

    Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)


  4. Change in Modified Ashworth scale [ Time Frame: Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) ]

    It assesses muscle tone at the shoulder, elbow and wrist.

    Time frame:

    Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)



Other Outcome Measures:
  1. Change in Choice reaction task [ Time Frame: Two days before and two days after the three-week mCIMT + SR intervention ]

    The children respond by pressing the buttons on an oversized number pad with keys specifying for pressing with the index finger or the thumb. Stimuli are pictures of an outlined hand with responding digit highlighted. When the child sees a thumb highlighted, he or she is required to press the thumb key with the thumb. Alternatively, he or she will press the index finger key with the index finger if the index finger is highlighted in the picture.

    Event-related potentials (ERPs) are recorded from a 64-channel array of electrodes placed in an extended 10-20 system.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with diagnosis of hemiplegic CP,
  • 6-18 years of age studying at local special school for students with physical handicap (PH),
  • intelligence ranging from normal to mild grade mental retardation,
  • the ability to extend the wrist at least 20° and the metacarpophalangeal joint 10° from full flexion, and
  • no balance problems sufficient to compromise safety.

Exclusion Criteria:

  • any health problems that were not associated with CP, and
  • severe muscle tone with modified Ashworth scale scored greater than 3.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957708


Locations
Layout table for location information
Hong Kong
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Sponsors and Collaborators
University of Western Sydney
The Hong Kong Polytechnic University

Layout table for additonal information
Responsible Party: Karen Liu, Associate Professor, University of Western Sydney
ClinicalTrials.gov Identifier: NCT02957708     History of Changes
Other Study ID Numbers: SR-CIMT_CP
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases