NCT01743430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
Completed

Started Nov 2008

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
Last Updated

December 6, 2012

Status Verified

November 1, 2012

Enrollment Period

2.9 years

First QC Date

October 20, 2011

Last Update Submit

December 5, 2012

Conditions

Stroke

Keywords

telerehabilitationstrokeBerg balance scalestroke impact scalemobility

Outcome Measures

Primary Outcomes (1)

  • Changes of Berg Balance Scale

    To measure static and dynamic balance during daily activities

    1 month

Secondary Outcomes (1)

  • Changes of Stroke Impact Scale (SIS)

    1 month

Study Arms (2)

telerehabilitation

EXPERIMENTAL

telerehabilitation via internet

Other: telerehabilitation

conventional

NO INTERVENTION

conventional therapy

Interventions

telerehabilitationOTHER

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

Also known as: physical therapy
telerehabilitation

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

TelerehabilitationPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Kwan-Hwa Lin, PhD

    School and Graduate Institute of Physical Therapy, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

December 6, 2012

Study Start

November 1, 2008

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 6, 2012

Record last verified: 2012-11

Locations

TW(1)