- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300867
Robotic Rehabilitation Treatment of Stroke Patients
August 2, 2023 updated by: Tollár József, Somogy Megyei Kaposi Mór Teaching Hospital
Storke results in severe deterioration in quality of life and exercise.
Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly.
In the acute / subacute phase, patients are given robotic treatment.
In addition to the study of mtoros functions, the study of gait and codination is the primary result.
Patients treated with soft exoskeleton receive 15 treatments and movement testing is performed continuously.
Members of the control group receive standard rehabilitation therapy.
After 3 weeks, both groups will participate in a control study and then in a repeat control study at week 6.
Our main goal is to compare the results and determine the efficiency of the robotic device.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
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
-
-
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
55 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
post stroke 6MWT : 120> minimum after stroke 3 days
Exclusion Criteria:
Sever heart problem sever demeanor alcoholism drug problems
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 |
---|---|
Active Comparator: Controll
|
Physiotherapy 3-week-long
Other Names:
|
Active Comparator: Robotic
|
Neurorehabilitation with soft exsoskeleton robotic 3-week-long
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualiti of life measured by Barthel index
Time Frame: 3 weeks
|
quetionnaire
|
3 weeks
|
gait/functional test
Time Frame: 3 weeks
|
6 minute walk test (m)
|
3 weeks
|
gait/functional test
Time Frame: 3 weeks
|
10 m walk test (m/s)
|
3 weeks
|
balance test
Time Frame: 3 weeks
|
Berg balance test
|
3 weeks
|
postural control test
Time Frame: 3 weeks
|
posturography
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2022
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
November 1, 2022
Study Registration Dates
First Submitted
March 19, 2022
First Submitted That Met QC Criteria
March 19, 2022
First Posted (Actual)
March 29, 2022
Study Record Updates
Last Update Posted (Actual)
August 3, 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
- IKEB2021/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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