Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage

Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study

This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Brain Damage; Traumatic Brain Damage
• Intervention / Treatment: Behavioral: Modified Constraint-induced Movement Therapy

Detailed Description

"Modified Constraint-Induced Movement Therapy" is one of the most recent treatments for children with Brain damage.

This well-designed and follow-up RCT study compared home-based CIT with a control intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical evaluation, which is possible to examine whether functional improvement is accompanied by a change in motor control. We hypothesized that home-based CIT would induce better motor control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV)) for greater functional gains than TR. Furthermore, the beneficial effects would be maintained at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the underlying motor control changes for functional improvement after home-based CIT.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Development learned-nonuse
2. Age range 4y/o-15y/o
3. Wrist ext 10˚, MP j't ext 10˚ in affected U/E
4. Can fallow up the simple instruction
5. Modified Ashworth Scale ≦2
6. Pediatric Motor Activity Log ≦2.5 (average)

Exclusion Criteria:

1. Related muscle skeleton surgery
2. Selective dorsal rhizotomy
3. Botulinum toxin in 6 months
4. Visual perception impaired
5. Hearing perception impaired
6. Balance ability impaired (in constrained)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Constraint-induced Movement Therapy	Behavioral: Modified Constraint-induced Movement Therapy; Home based CIT; Restriction of the less affected limb; Intensive practice using affected limb; Positive experience; Functional task (task); Other Names: Constraint-Induced Therapy; Forced-use Therapy; Immobilization Therapy
OTHER: Transditional rehabilitation	Behavioral: Modified Constraint-induced Movement Therapy; Home based CIT; Restriction of the less affected limb; Intensive practice using affected limb; Positive experience; Functional task (task); Other Names: Constraint-Induced Therapy; Forced-use Therapy; Immobilization Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)	All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.	4 weeks (post-treatment), 12 week, 24 week
Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)		4 weeks (post-treatment), 12 week, 24 week
Kinematic analysis		4 weeks (post-treatment), 12 week, 24 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Motor Activity Log ( PMAL )	All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.	4 weeks (post-treatment), 12 week, 24 week
Pediatric Functional Independence Measure ( WeeFIM )		4 weeks (post-treatment), 12 week, 24 week
Cerebral palsy quality of life (CPQoL)		4 weeks (post-treatment), 12 week, 24 week

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chia-Ling chen, MD,PhD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: January 4, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (ESTIMATE): February 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 31, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Quality of life; outcome; function; constraint induced movement therapy; kinematic; brain damage
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Cerebral Palsy; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 97-1823B