NCT00564005

Brief Summary

Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

November 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 11, 2015

Status Verified

September 1, 2014

Enrollment Period

2.9 years

First QC Date

November 25, 2007

Last Update Submit

February 10, 2015

Conditions

Cerebrovascular Accidents

Keywords

stroke rehabilitationcortical reorganizationkinematic analysis

Outcome Measures

Primary Outcomes (1)

  • Cortical reorganization and kinematic analysis

    2008-2010

Secondary Outcomes (1)

  • clinical measures at the impairment, activity, participation levels

    2008-2010

Study Arms (4)

1

EXPERIMENTAL

constraint-induced therapy

Other: Constraint-induced therapy (CIT)

2

EXPERIMENTAL

bilateral arm training

Other: Bilateral arm training (BAT)

3

EXPERIMENTAL

combined therapy

Other: Combined therapy (CT)

Control intervention

ACTIVE COMPARATOR
Behavioral: Control intervention

Interventions

Constraint-induced therapy (CIT)OTHER

restraint of the unaffected arm and practice of the affected arm

1
Bilateral arm training (BAT)OTHER

bilateral symmetric, repetitive arm training

2
Combined therapy (CT)OTHER

combined different treatment approaches

3
Control interventionBEHAVIORAL

Conventional treatment program

Control intervention

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a first-ever clinical cerebrovascular accident patients
  • at least 6 months post-stroke onset
  • premorbid right-hand dominance
  • demonstration of Brunnstrom stage III of the affected upper extremity
  • no excessive spasticity in the joints of the affected upper extremity

You may not qualify if:

  • a score of less than 24 on the Mini Mental State Exam
  • poor physical conditions that would interfere with participation
  • excessive pain in any joint that might limit participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, 333, Taiwan

Location

Related Publications (1)

  • Wu CY, Chen YA, Lin KC, Chao CP, Chen YT. Constraint-induced therapy with trunk restraint for improving functional outcomes and trunk-arm control after stroke: a randomized controlled trial. Phys Ther. 2012 Apr;92(4):483-92. doi: 10.2522/ptj.20110213. Epub 2012 Jan 6.

    PMID: 22228607DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement TherapyPsychotherapy, Multiple

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationPsychotherapyBehavioral Disciplines and Activities

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
SPONSOR

Study Record Dates

First Submitted

November 25, 2007

First Posted

November 27, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 11, 2015

Record last verified: 2014-09

Locations

TW(1)