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

Chronic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364232
• Other study ID #: 103-3962A3
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: May 17, 2017
• Start date: September 2014
• Est. completion date: April 12, 2017

Study information

• Verified date: November 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 12, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke

Intervention

Behavioral:
• bilateral training with and without mirror feedback

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kaohsiung County
Taiwan	Chang Gung Memorial Hospital	Taoyuan County

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Mini-Mental State Exam, MMSE		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	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.
Primary	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.
Primary	Revised Nottingham Sensory Assessment		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	10-Meter Walking Test, 10MWT		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	Box and Block Test, BBT		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	Wolf Motor Function Test, WMFT		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	Chedoke Arm and Hand Activity Inventory		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	Canadian Occupational Performance Measure, COPM		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	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.
Primary	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.
Primary	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.
Primary	Actigraphy		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	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.
Primary	The World Health Organization Quality of Life -Brief version, WHOQOL-BRE		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	Medical Research Council scale,MRC		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	6 minute walk test		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	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.
Primary	Lawton-Brody IADL Scale		Change from baseline up to 4 weeks immediately after the completion of intervention
Primary	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	Montreal Cognitive Assessment, MoCA		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	Minnesota Rate of Manipulation Test during dual Task		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	Stroop Test		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	Movement Imagery Questionnaire- Revised, Second Edition, MIQ-RS		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	Kinesthetic and Visual Imagery Questionnaire-10, KVIQ-10		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	Modified Rankin Scale, mRS		baseline
Secondary	30 second sit-to-stand test		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	Timed up and go test		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	The stroke self-efficacy questionnaire		Change from baseline up to 4 weeks immediately after the completion of intervention
Secondary	BDI-II,Beck Depression Inventory II		Change from baseline up to 4 weeks immediately after the completion of intervention