Robotic Versus Conventional Training on Hemiplegic Gait. (BB200810)

July 15, 2012 updated by: Ratanapat Chanubol, Prasat Neurological Institute

A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.

The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Prasat Neurological Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Subacute first-time stroke patients(hemorrhage and ischemic)
  • Age 18-80 years.
  • Impaired Functional Ambulation Category at initial score 0-2
  • Cardiovascular stable
  • Given signed inform consent

Exclusion Criteria:

  • Unstable general medical condition
  • Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree
  • Any functional impairment prior to stroke

  • Can not adequately cooperate in training

    • Severe communication problems
    • Severe cognitive - perceptual deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
Group A = conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
Behavioral: conventional therapy
conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
ACTIVE_COMPARATOR: Group B
Group B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
Device: conventional plus robotic gait assisted therapy
individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy
Other Names:
  • Gait trainer GT1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulation Categories (FAC, 0-5)
Time Frame: 4 weeks
Description of ambulation level of the individual patient, whether and if, how much support is needed.
4 weeks
Barthel index (BI, 0-100)
Time Frame: 4 weeks
Assesses independence in activity of daily living
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berg Balance Scale (BBS, 0-56
Time Frame: 4 weeks
Assesses balance abilities.
4 weeks
REPAS -Muscle tone (REPAS, 0-52)
Time Frame: 4 weeks
Sum score to assess muscle tone for the major joints of the upper and lower extremities.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prasat Neurological Institute

Collaborators

Charite University, Berlin, Germany
Mahidol University

Investigators

  • Principal Investigator: Ratanapat Chanubol, M.D., Rehabilitation department, Prasat Neurological Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 23, 2010

First Posted (ESTIMATE)

August 24, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 15, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB200810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on conventional therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe