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

NCT02364232 | Completed

• 1 other identifier: 103-3962A3
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (21)

• Fugl-Myer Assessment, FMA

  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.

• Mini-Mental State Exam, MMSE

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

• pinch and grasp dynamometer

  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.

• Modified Ashworth Scale, MAS

  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.

• Revised Nottingham Sensory Assessment

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

• 10-Meter Walking Test, 10MWT

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

• Box and Block Test, BBT

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

• Wolf Motor Function Test, WMFT

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

• Chedoke Arm and Hand Activity Inventory

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

• Canadian Occupational Performance Measure, COPM

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

• Nottingham Extended Activities of Daily Living, NEADL

  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.

• ABILHAND Questionnaire

  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.

• Motor Activity Log, MAL

  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.

• Actigraphy

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

• Stroke Impact Scale, SIS

  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.

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

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

• Medical Research Council scale,MRC

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

• 6 minute walk test

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

• The Euroqol Quality of Life Scale

  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.

• Lawton-Brody IADL Scale

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

• Pittsburg Sleep Quality Index

  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 (10)

• Montreal Cognitive Assessment, MoCA

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

• Minnesota Rate of Manipulation Test during dual Task

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

• Stroop Test

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

• Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS

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

• Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10

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

Study Arms (2)

Home-based

EXPERIMENTAL

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

Clinic-based

ACTIVE COMPARATOR

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

bilateral training with and without mirror feedback BEHAVIORAL

Clinic-based; Home-based

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Chang Gung Memorial Hospital

Kaohsiung County, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 29702070 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: February 18, 2015
• Study Start: September 1, 2014
• Primary Completion: April 12, 2017
• Study Completion: April 12, 2017
• Last Updated: May 19, 2017

Record last verified: 2016-11

Locations

TW (2)