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Completed

NCT Number: NCT01076257

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

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.

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Key information

Conditions

Brain Damage Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cerebral Palsy Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Traumatic Brain Damage Wounds and Injuries

Age range

4 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Related muscle skeleton surgery
  • Selective dorsal rhizotomy
  • Botulinum toxin in 6 months
  • Visual perception impaired
  • Hearing perception impaired
  • Balance ability impaired (in constrained)

Treatment and study plan

Modified constraint-induced movement therapy

Behavioral

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

Primary outcomes

  1. Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)

    Time frame: 4 weeks (post-treatment), 12 week, 24 week

    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.

  2. Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)

    Time frame: 4 weeks (post-treatment), 12 week, 24 week

  3. Kinematic analysis

    Time frame: 4 weeks (post-treatment), 12 week, 24 week

Secondary outcomes

  1. Pediatric Motor Activity Log ( PMAL )

    Time frame: 4 weeks (post-treatment), 12 week, 24 week

    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.

  2. Pediatric Functional Independence Measure ( WeeFIM )

    Time frame: 4 weeks (post-treatment), 12 week, 24 week

  3. Cerebral palsy quality of life (CPQoL)

    Time frame: 4 weeks (post-treatment), 12 week, 24 week

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 26, 2010
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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