NCT01076257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

July 31, 2012

Status Verified

May 1, 2010

Enrollment Period

1.1 years

First QC Date

January 4, 2010

Last Update Submit

July 30, 2012

Conditions

Brain DamageCerebral PalsyTraumatic Brain Damage

Keywords

brain damageconstraint induced movement therapykinematicfunctionoutcomeQuality of life

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Pediatric Motor Activity Log ( PMAL )

    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

Study Arms (2)

Constraint-induced Movement Therapy

EXPERIMENTAL
Behavioral: Modified Constraint-induced Movement Therapy

Transditional rehabilitation

OTHER
Behavioral: Modified Constraint-induced Movement Therapy

Interventions

Modified Constraint-induced Movement TherapyBEHAVIORAL

Home based CIT 1. Restriction of the less affected limb 2. Intensive practice using affected limb 3. Positive experience 4. Functional task (task)

Also known as: Constraint-Induced Therapy, Forced-use Therapy, Immobilization Therapy
Constraint-induced Movement TherapyTransditional rehabilitation

Eligibility Criteria

Age4 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Brain InjuriesCerebral PalsyBrain Injuries, Traumatic

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain Damage, Chronic

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Chia-Ling chen, MD,PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2010

First Posted

February 26, 2010

Study Start

June 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

July 31, 2012

Record last verified: 2010-05

Locations

TW(1)