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

Stroke Clinical Trial

— telerehab  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743430
• Other study ID #: 200809040R
• Status: Completed
• Phase: Phase 2
• First received: October 20, 2011
• Last updated: December 5, 2012
• Start date: November 2008
• Est. completion date: October 2011

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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.

Exclusion Criteria:

• Those with other major diseases (e.g., Parkinson disease and severe osteoarthritis) and unstable medical conditions during the study period.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Taiwan	School and Graduate Institute of Physical Therapy, National Taiwan University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Berg Balance Scale	To measure static and dynamic balance during daily activities	1 month	Yes
Secondary	Changes of Stroke Impact Scale (SIS)	the quality of life questionnaire	1 month	Yes