NCT00778453

Brief Summary

The findings of this study will advance movement reorganization mechanism underlying treatment approaches and clinical intervention techniques. These findings may inform rehabilitation professionals about which treatment approach is superior to another one in certain aspect of outcome and who can benefit most from certain treatment approach. Accordingly, the results of this project may help us move quickly to design and develop efficient and effective rehabilitation programs for individualized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

2.9 years

First QC Date

October 5, 2008

Last Update Submit

July 31, 2012

Conditions

Keywords

stroke rehabilitationkinematic analysisupper extremity trainingpredictors

Outcome Measures

Primary Outcomes (1)

  • kinematic analysis

    2008-2011

Secondary Outcomes (1)

  • clinical measures

    2008-2011

Study Arms (6)

Hospital-based mCIT

EXPERIMENTAL

Hospital-based modified constraint-induced therapy(mCIT)

Other: Hospital-based mCIT

Hospital-based BIT

EXPERIMENTAL

Hospital-based bilateral isokinematic training (BIT)

Other: Hospital-based BIT

Hospital-based TR

EXPERIMENTAL

Hospital-based traditional rehabilitation (TR)

Other: Hospital-based TR

Home-based BAT

EXPERIMENTAL

Home-based bilateral arm training(BAT)

Other: Home-based BAT

Home-based TR

EXPERIMENTAL

Home-based traditional rehabilitation (TR)

Other: Home-based TR

Home-based mCIT

EXPERIMENTAL

Home-based modified constraint-induced therapy (mCIT)

Other: Home-based mCIT

Interventions

restraint of the unaffected arm and practice of the affected arm

Also known as: Hospital-based modified constraint-induced therapy(mCIT)
Hospital-based mCIT

bilateral symmetric, repetitive arm training

Also known as: Hospital-based bilateral isokinematic training (BIT)
Hospital-based BIT

hospital-based traditional rehabilitation : OT or PT or therapist-based training

Also known as: Hospital-based traditional rehabilitation (TR)
Hospital-based TR

restraint of the unaffected arm and practices of the affected arm

Also known as: Home-based modified constraint-induced therapy (mCIT)
Home-based mCIT

bilateral symmetric, repetitive arm training

Also known as: Home-based bilateral arm training (BAT)
Home-based BAT

home-based traditional rehabilitation:OT or PT or therapist-based training

Also known as: Home-based traditional rehabilitation (TR)
Home-based TR

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the onset duration more than 6 months
  • Brunnstrom stage III above for the proximal part and distal part of UL
  • no serious cognitive deficits
  • no balance problems sufficient to compromise safety when wearing the project's constraint device

You may not qualify if:

  • a score of less than 24 on the Mini Mental State Exam

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kwei-shan, Toayuan, Taiwan

Location

Related Publications (1)

  • Lin KC, Chuang LL, Wu CY, Hsieh YW, Chang WY. Responsiveness and validity of three dexterous function measures in stroke rehabilitation. J Rehabil Res Dev. 2010;47(6):563-71. doi: 10.1682/jrrd.2009.09.0155.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ching-yi Wu, ScD

    Department of Occupational Therapy, Chang Gung Univ

    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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 5, 2008

First Posted

October 23, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations