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

NCT ID: NCT02364232

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

bilateral training with and without mirror feedback

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

bilateral training with and without mirror feedback

Intervention Type BEHAVIORAL

Interventions

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bilateral training with and without mirror feedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Kaohsiung County, , Taiwan

Site Status

Chang Gung Memorial Hospital

Taoyuan, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 29702070 (View on PubMed)

Other Identifiers

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103-3962A3

Identifier Type: -

Identifier Source: org_study_id

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