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CompletedNCT02364232Updated May 19, 2017

Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation

An interventional study of bilateral training with and without mirror feedback in Chronic Stroke, sponsored by Chang Gung Memorial Hospital. Completed at 2 sites in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study was to compare the treatment effects of home-based or clinic-based bilateral training with and without mirror feedback programon on physiological markers, sensorimotor, cognition, daily functions, and participation among patients with chronic stroke.

02

Conditions studied

  • Chronic Stroke
03

In context

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,091 studies on the registry; 237 are open to participants now.

Browse Chang Gung Memorial Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The most recent stroke was between 1 month and 5 years
  • No serious cognitive impairment (MMSE≥21)
  • FMA score =18-62
  • No serious muscle spasticity in shoulder, elbow, wrist and finger (MAS≤3)
  • Modified rankin Scale=2 to 4

Exclusion criteria

Exclusion Criteria:

  • Aphasia that might interfere with understanding instructions
  • Stroke in areas other than the brain and brainstem, such as the cerebellum
  • other neurological disease, such as dementia
  • Muscle and joint have serious pain and inflammatory swelling in affected side.
  • Cannot control hypertension, heart disease and serious throbosis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Home-based

    Participants in home-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the home-based training, a four-week wash-out period followed. Then, patients will receive the clinic-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed.

    Behavioral: bilateral training with and without mirror feedback

  • Active comparator
    Clinic-based

    Participants in clinic-based training graoup will receive 1.5 hours/ day, 3 days a week, for 4 contious weeks at home. Participants will receive 2 training stages, including bilateral training with mirror feedback for 30-45 minutes and functional training for 45-60 minutes. Each training stage hase to include above 2 activities.After the end of the clinic-based training, a four-week wash-out period followed. Then, patients will receive the home-based training for 4 continuous weeks. Before and after the treatment, a total of 4 evaluations were conducted, including clinical assessments and blood test (each 9c.c.). One month after the end of the course of treatment will be assessed.

    Behavioral: bilateral training with and without mirror feedback

Interventions

  • Behavioralbilateral training with and without mirror feedback
06

What researchers measure

Primary outcomes

  1. Fugl-Myer Assessment, FMA

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  2. Mini-Mental State Exam, MMSE

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  3. pinch and grasp dynamometer

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  4. Modified Ashworth Scale, MAS

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  5. Revised Nottingham Sensory Assessment

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  6. 10-Meter Walking Test, 10MWT

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  7. Box and Block Test, BBT

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  8. Wolf Motor Function Test, WMFT

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  9. Chedoke Arm and Hand Activity Inventory

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  10. Canadian Occupational Performance Measure, COPM

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  11. Nottingham Extended Activities of Daily Living, NEADL

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  12. ABILHAND Questionnaire

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  13. Motor Activity Log, MAL

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  14. Actigraphy

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  15. Stroke Impact Scale, SIS

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  16. The World Health Organization Quality of Life -Brief version, WHOQOL-BRE

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  17. Medical Research Council scale,MRC

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  18. 6 minute walk test

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  19. The Euroqol Quality of Life Scale

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

  20. Lawton-Brody IADL Scale

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  21. Pittsburg Sleep Quality Index

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention, and change from 4 weeks up immediately after the completion of intervention up to 3 months after the completion of intervention.

Secondary outcomes

  1. Montreal Cognitive Assessment, MoCA

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  2. Minnesota Rate of Manipulation Test during dual Task

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  3. Stroop Test

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  4. Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  5. Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  6. Modified Rankin Scale, mRS

    Time frame: baseline

  7. 30 second sit-to-stand test

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  8. Timed up and go test

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  9. The stroke self-efficacy questionnaire

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

  10. BDI-II，Beck Depression Inventory II

    Time frame: Change from baseline up to 4 weeks immediately after the completion of intervention

07

Study locations

2 sites
  • Chang Gung Memorial Hospital
    Kaohsiung County, Taiwan
  • Chang Gung Memorial Hospital
    Taoyuan County, Taiwan
08

References and documents

Publications

  • Hsieh YW, Chang KC, Hung JW, Wu CY, Fu MH, Chen CC. Effects of Home-Based Versus Clinic-Based Rehabilitation Combining Mirror Therapy and Task-Specific Training for Patients With Stroke: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2018 Dec;99(12):2399-2407. doi: 10.1016/j.apmr.2018.03.017. Epub 2018 Apr 25. PubMed 29702070 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Apr 2017 and a completion of Apr 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2015
First posted
Feb 18, 2015
Start
Sep 2014
Primary completionActual
Apr 12, 2017
CompletionActual
Apr 12, 2017
Last update
May 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02364232
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Feb 18, 2015
Start date
Sep 2014
Primary completion
Apr 12, 2017
Completion
Apr 12, 2017
Last update
May 19, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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