NCT02548234

Brief Summary

The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable stroke

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

September 9, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

September 11, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2017

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

September 9, 2015

Last Update Submit

September 1, 2020

Conditions

Stroke

Keywords

StrokeRandomized control trialMirror therapyBilateral arm trainingComparative efficacy researchNeurorehabilitation

Outcome Measures

Primary Outcomes (1)

  • The efficacy of mirror therapy versus bilateral arm training on sensorimotor functions

    Revised Nottingham Sensory Assessment and Fugl-Meyer Assessment will be used to measure sensorimotor functions. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.

    within four weeks (plus or minus 3 days) after intervention

Secondary Outcomes (3)

  • The efficacy of mirror therapy versus bilateral arm training on motor performance

    within four weeks (plus or minus 3 days) after intervention

  • The efficacy of mirror therapy versus bilateral arm training on motor performance

    within four weeks (plus or minus 3 days) after intervention

  • The efficacy of mirror therapy versus bilateral arm training on quality of life

    within four weeks (plus or minus 3 days) after intervention

Study Arms (2)

Mirror therapy

EXPERIMENTAL

Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.

Other: Mirror therapy

Bilateral arm training

EXPERIMENTAL

Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.

Other: Bilateral arm training

Interventions

Mirror therapyOTHER

Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.

Mirror therapy
Bilateral arm trainingOTHER

Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.

Bilateral arm training

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 6 months after onset of an ischemic or hemorrhage stroke
  • no excessive spasticity on all joints of the affected arm

You may not qualify if:

  • history of stroke or other neurologic, neuromuscular, or orthopedic disease
  • participation in other experimental rehabilitation or drug studies concurrent with this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

Related Publications (4)

  • Thieme H, Mehrholz J, Pohl M, Behrens J, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD008449. doi: 10.1002/14651858.CD008449.pub2.

    PMID: 22419334BACKGROUND

  • Wu CY, Huang PC, Chen YT, Lin KC, Yang HW. Effects of mirror therapy on motor and sensory recovery in chronic stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2013 Jun;94(6):1023-30. doi: 10.1016/j.apmr.2013.02.007. Epub 2013 Feb 15.

    PMID: 23419791BACKGROUND

  • Samuelkamaleshkumar S, Reethajanetsureka S, Pauljebaraj P, Benshamir B, Padankatti SM, David JA. Mirror therapy enhances motor performance in the paretic upper limb after stroke: a pilot randomized controlled trial. Arch Phys Med Rehabil. 2014 Nov;95(11):2000-5. doi: 10.1016/j.apmr.2014.06.020. Epub 2014 Jul 23.

    PMID: 25064777BACKGROUND

  • Wolf A, Scheiderer R, Napolitan N, Belden C, Shaub L, Whitford M. Efficacy and task structure of bimanual training post stroke: a systematic review. Top Stroke Rehabil. 2014 May-Jun;21(3):181-96. doi: 10.1310/tsr2103-181.

    PMID: 24985386BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Keh-Chung Lin, ScD

    National Taiwan University

    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

September 9, 2015

First Posted

September 14, 2015

Study Start

September 11, 2015

Primary Completion

October 6, 2017

Study Completion

October 6, 2017

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

TW(1)