Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients

August 2, 2023 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
We are conducting a three-group comparative study on stroke patients. The treatment is started in a subacute state and completed in the hospital. The essence of robot-assisted treatments is faster recovery and better learning to walk. The group will do a special walking exercise with a robot. The walking group does the same training, only without robotic assistance. The control group will receive physiotherapy treatments financed by the state. Control examination after 3 weeks.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

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

  • Hungary
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Dr. Tollár József

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

post stroke 6MWT : 120> minimum after stroke 3 days be a stroke patient first stroke hemiplegia

Exclusion Criteria:

multiple strokes, inability to stand and walk, cognitive function disorder does not reach 50 meters with a minimal walking aid Alcohol Sever heart problem sever demeanor alcoholism drug problems Drug

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotically treated patient
They performed training with a robot 15 times over 3 weeks.
Other: Learning to walk with a robot
The patients completed a 1-hour learning to walk program using a soft exoskeleton. The protocol includes several difficult parts of the walk. (Walking protocol)
Other Names:
  • ROB
Experimental: Walking training
Walking exercises were performed without a robot.
Other: Walking group
The walking protocol was performed without robotic assistance for 1 hour every day for 3 weeks.
Other Names:
  • WALK
Experimental: Control group
Physiotherapy treatment was carried out by the patients.
Other: Control group
The control group performed the physiotherapy treatment for 3 weeks.
Other Names:
  • CON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS)
Time Frame: 3 weeks (0-5 score, high score better)
stroke, diagnostic, quality of life
3 weeks (0-5 score, high score better)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index for Activities of Daily Living (ADL)
Time Frame: 3 weeks
stroke quality of life
3 weeks
10-m maximal walking speed
Time Frame: 3 weeks
high speed test
3 weeks
6MWT
Time Frame: 3 weeks
walking test
3 weeks
Berg Balance Scale
Time Frame: 3 weeks (0-30, high score better)
balance test
3 weeks (0-30, high score better)

Collaborators and Investigators

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

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital

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.

Helpful Links

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 (Actual)

July 9, 2023

Primary Completion (Estimated)

August 30, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

July 9, 2023

First Submitted That Met QC Criteria

July 9, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IKEB/2022/02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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