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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
telerehabilitation
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring telerehabilitation, stroke, Berg balance scale, stroke impact scale, mobility

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School and Graduate Institute of Physical Therapy, National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

telerehabilitation

conventional

Arm Description

telerehabilitation via internet

conventional therapy

Outcomes

Primary Outcome Measures

Changes of Berg Balance Scale
To measure static and dynamic balance during daily activities

Secondary Outcome Measures

Changes of Stroke Impact Scale (SIS)
the quality of life questionnaire

Full Information

First Posted
October 20, 2011
Last Updated
December 5, 2012
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01743430
Brief Title
Development of Smart Holistic Telerehabilitation System: An Application of Stroke Patients- 3 Years Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
telerehabilitation, stroke, Berg balance scale, stroke impact scale, mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
telerehabilitation
Arm Type
Experimental
Arm Description
telerehabilitation via internet
Arm Title
conventional
Arm Type
No Intervention
Arm Description
conventional therapy
Intervention Type
Other
Intervention Name(s)
telerehabilitation
Other Intervention Name(s)
physical therapy
Intervention Description
telerehabilitation for 4 weeks, 2 sessions per week and 30 to 50 minutes per session
Primary Outcome Measure Information:
Title
Changes of Berg Balance Scale
Description
To measure static and dynamic balance during daily activities
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Changes of Stroke Impact Scale (SIS)
Description
the quality of life questionnaire
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwan-Hwa Lin, PhD
Organizational Affiliation
School and Graduate Institute of Physical Therapy, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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