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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01743430
First received: October 20, 2011
Last updated: December 5, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Stroke
Other: telerehabilitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Changes of Berg Balance Scale [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    To measure static and dynamic balance during daily activities


Secondary Outcome Measures:
  • Changes of Stroke Impact Scale (SIS) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    the quality of life questionnaire


Enrollment: 80
Study Start Date: November 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: telerehabilitation
telerehabilitation via internet
Other: telerehabilitation
telerehabilitation for 4 weeks, 2 sessions per week and 30 to 50 minutes per session
Other Name: physical therapy
No Intervention: conventional
conventional therapy

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743430

Locations
Taiwan
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Kwan-Hwa Lin, PhD School and Graduate Institute of Physical Therapy, National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01743430     History of Changes
Other Study ID Numbers: 200809040R
Study First Received: October 20, 2011
Last Updated: December 5, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
telerehabilitation
stroke
Berg balance scale
stroke impact scale
mobility

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014