Clinical trial NCT01076257: Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage
Official title: Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Damage
Cerebral Palsy
Traumatic Brain Damage
Keywords: brain damage
constraint induced movement therapy
kinematic
function
outcome
Quality of life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 48
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)
timeFrame: 4 weeks (post-treatment), 12 week, 24 week
measure: Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)
timeFrame: 4 weeks (post-treatment), 12 week, 24 week
measure: Kinematic analysis
timeFrame: 4 weeks (post-treatment), 12 week, 24 week
Secondary outcomes:
measure: Pediatric Motor Activity Log ( PMAL )
timeFrame: 4 weeks (post-treatment), 12 week, 24 week
measure: Pediatric Functional Independence Measure ( WeeFIM )
timeFrame: 4 weeks (post-treatment), 12 week, 24 week
measure: Cerebral palsy quality of life (CPQoL)
timeFrame: 4 weeks (post-treatment), 12 week, 24 week
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: