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

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ClinicalTrials.gov Identifier: NCT02364232
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Stroke Behavioral: bilateral training with and without mirror feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation: Bilateral Training With and Without Mirror Feedback Program
Study Start Date : September 2014
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364232


Locations
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Taiwan
Chang Gung Memorial Hospital
Kaohsiung County, Taiwan
Chang Gung Memorial Hospital
Taoyuan County, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02364232    
Other Study ID Numbers: 103-3962A3
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: November 2016