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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076257
• Other study ID #: 97-1823B
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: July 30, 2012
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: May 2010
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Brain Damage
• Brain Injuries
• Cerebral Palsy
• Traumatic Brain Damage

Intervention

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)

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Peabody Development Motor Scales, subtest fine motor (PDMS-?)		4 weeks (post-treatment), 12 week, 24 week	No
Primary	Kinematic analysis		4 weeks (post-treatment), 12 week, 24 week	No
Secondary	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	No
Secondary	Pediatric Functional Independence Measure ( WeeFIM )		4 weeks (post-treatment), 12 week, 24 week	No
Secondary	Cerebral palsy quality of life (CPQoL)		4 weeks (post-treatment), 12 week, 24 week	No