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

NCT ID: NCT01743430

Last Updated: 2012-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-10-31

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.

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.

Conditions

Stroke

Keywords

telerehabilitation; stroke; Berg balance scale; stroke impact scale; mobility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

telerehabilitation

telerehabilitation via internet

Group Type: EXPERIMENTAL

telerehabilitation

Intervention Type: OTHER

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

conventional

conventional therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telerehabilitation

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

Intervention Type: OTHER

Other Intervention Names

physical therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kwan-Hwa Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

School and Graduate Institute of Physical Therapy, National Taiwan University

Locations

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

200809040R

Identifier Type: -

Identifier Source: org_study_id