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Completed

NCT Number: NCT02364232

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

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.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Kaohsiung County, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

bilateral training with and without mirror feedback

Behavioral

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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2015
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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