telerehab: Development of Smart Holistic Telerehabilitation System: An Application of Stroke Patients- 3 Years Study

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01743430

Collaborator

National Science Council, Taiwan (Other)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study 1: Background and Purpose-This study were to set up the telerehabilitation program for standing balance training, and to examine the training effects on balance and daily activities in subjects with subacute stroke.The null hypothesis included telerehabilitation balance training were not significantly different from conventional balance training in subjects with subacute stroke.

Study 2: The purpose of this study was to investigate the effects of telerehabilitation with group therapy on balance and daily activities in subjects with stroke living in long-term care facilities (LTC).The null hypothesis would be telerehabilitation balance training were not significantly different from conventional balance training in subjects with subacute stroke.

study 3:To investigate whether a four-week tele-rehabilitation program can result in significant improvements in physical function and quality of life for subjects with chronic stroke living in long-term care facilities.

Study 4: To compare the effects of a home-based telerehabilitation (Tele) with intelligent agent systems and a conventional in-home physical therapy (home PT) for subjects with stroke.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: telerehabilitation	Phase 2

Detailed Description

Study 1: Methods-Twenty-four subjects with substroke (less than 6 months post-stroke) were recruited for telerehabilitation group and conventional balance training group. Study 2. Methods-Twenty -four participants with mild to moderate stroke were randomized into telerehabilitation (Tele) group and conventional (Conv) group. They received balance training with three sessions per week for 4 weeks. The pressure distribution of buttock-pressure interface was measured by Pressure Distribution Plate (PDM-S).

Study 3.Methods: Twenty-four participants were recruited from three long-term care facilities. Participants were assigned into tele-rehabilitation (Tele group) and conventional Groups (Con group) randomly. Baseline and post-treatment physical function, daily activities and health-related quality of life (HRQOL) were assessed by Simplified-STREAM, Berge Balance scale (BBS), Barthel index (BI), and Stroke Impact Scale (SIS 3.0), respectively. Interventions were conducted to both groups by two different physical therapists with three sessions a week for four weeks of intervention.

Study 4. Ten participants with stroke were randomized into Tele or control group 1 (CG1) for randomized controlled trial. The Tele group also received home PT at 3 weeks later as control group 2 (CG2) for cross over design.

Intervention: All three groups received 4 weeks training (2 sessions/week, 50 minutes/session), including upper extremity and balance exercises.

Main outcome measures: The assessments were performed at baseline (pre), after 4 weeks (post) and after 7 weeks (follow-up). The measures for physical function included Stroke Rehabilitation Assessment (STREAM), Postural Assessment Scale for Stroke Patients (PASS), and Barthel index (BI). The measures for satisfaction included Stroke Impact Scale (SIS) and user-satisfaction questionnaires.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

1. Telerehabilitation on Balance in Subacute Stroke; 2.Telerehabilitation on Balance and Daily Activities in Chronic Stroke; 3. Telerehabilitation on Quality of Life in Chronic Stroke; 4. Telerehabilitation on Satisfaction in Stroke

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: telerehabilitation telerehabilitation via internet	Other: telerehabilitation telerehabilitation for 4 weeks, 2 sessions per week and 30 to 50 minutes per session Other Names: physical therapy
No Intervention: conventional conventional therapy

Arm

Intervention/Treatment

Experimental: telerehabilitation

telerehabilitation via internet

Other: telerehabilitation

telerehabilitation for 4 weeks, 2 sessions per week and 30 to 50 minutes per session

Other Names:

physical therapy

No Intervention: conventional

conventional therapy

Outcome Measures

Primary Outcome Measures

Changes of Berg Balance Scale [1 month]
To measure static and dynamic balance during daily activities

Secondary Outcome Measures

Changes of Stroke Impact Scale (SIS) [1 month]
the quality of life questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Having a first episode of unilateral stroke with hemiparesis,
Brunnstrom score between stages II and VI for the upper and lower hemiplegic extremities,
Being able to understand and follow simple verbal instructions.