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

Cerebral Palsy Clinical Trial

Official title:

Effectiveness of Modified Constraint-induced Movement Therapy and Self-regulation Learning for Children With Hemiplegic Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957708
• Other study ID #: SR-CIMT_CP
• Status: Completed
• Phase: N/A
• First received: September 22, 2016
• Last updated: November 3, 2016
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2016
• Source: University of Western Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Sydney	The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Choice reaction task	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.	Two days before and two days after the three-week mCIMT + SR intervention	No
Primary	Change in Bruininks-Oseretsky Test of Motor Proficiency	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)	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)	No
Primary	Change in Jebsen-Taylor Test of Hand Funcion	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)	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)	No
Secondary	Change in Caregiver Functional Use Survey	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)	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)	No
Secondary	Change in Grip strength	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)	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)	No
Secondary	Change in Pinch strength	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)	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)	No
Secondary	Change in Modified Ashworth scale	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)	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)	No