Back to resultsRobotic Rehabilitation Treatment of Stroke Patients
Primary Purpose
Stroke, Acute, Stroke, Ischemic
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Neurorehabilitation
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring balance, soft exoskeleton, walk, robotic
Eligibility Criteria
Inclusion Criteria:
post stroke 6MWT : 120> minimum after stroke 3 days
Exclusion Criteria:
Sever heart problem sever demeanor alcoholism drug problems
Sites / Locations
- Dr. Tollár József
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Robotic
Controll
Arm Description
Outcomes
Primary Outcome Measures
Qualiti of life measured by Barthel index
quetionnaire
gait/functional test
6 minute walk test (m)
gait/functional test
10 m walk test (m/s)
balance test
Berg balance test
postural control test
posturography
Secondary Outcome Measures
Full Information
NCT ID
NCT05300867
First Posted
March 19, 2022
Last Updated
August 2, 2023
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05300867
Brief Title
Robotic Rehabilitation Treatment of Stroke Patients
Official Title
Robotic Rehabilitation Treatment of Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute, Stroke, Ischemic
Keywords
balance, soft exoskeleton, walk, robotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robotic
Arm Type
Active Comparator
Arm Title
Controll
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Neurorehabilitation
Other Intervention Name(s)
Rob group
Intervention Description
Neurorehabilitation with soft exsoskeleton robotic 3-week-long
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Controll groum
Intervention Description
Physiotherapy 3-week-long
Primary Outcome Measure Information:
Title
Qualiti of life measured by Barthel index
Description
quetionnaire
Time Frame
3 weeks
Title
gait/functional test
Description
6 minute walk test (m)
Time Frame
3 weeks
Title
gait/functional test
Description
10 m walk test (m/s)
Time Frame
3 weeks
Title
balance test
Description
Berg balance test
Time Frame
3 weeks
Title
postural control test
Description
posturography
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
post stroke 6MWT : 120> minimum after stroke 3 days
Exclusion Criteria:
Sever heart problem sever demeanor alcoholism drug problems
Facility Information:
Facility Name
Dr. Tollár József
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=robotic+rehabilitation%2C+soft+exoskeleton
Description
Related Info
Learn more about this trial
Robotic Rehabilitation Treatment of Stroke Patients
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