Back to resultsEffect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
Primary Purpose
Stroke
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Learning to walk with a robot
Walking group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring robotic, stroke, rehabilitation
Eligibility Criteria
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
Sites / Locations
- Dr. Tollár József
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Robotically treated patient
Walking training
Control group
Arm Description
They performed training with a robot 15 times over 3 weeks.
Walking exercises were performed without a robot.
Physiotherapy treatment was carried out by the patients.
Outcomes
Primary Outcome Measures
Modified Rankin Scale (mRS)
stroke, diagnostic, quality of life
Secondary Outcome Measures
Barthel Index for Activities of Daily Living (ADL)
stroke quality of life
Berg Balance Scale
balance test
10-m maximal walking speed
high speed test
6MWT
walking test
Full Information
NCT ID
NCT05947773
First Posted
July 9, 2023
Last Updated
August 2, 2023
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05947773
Brief Title
Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
Official Title
Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 9, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
robotic, stroke, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robotically treated patient
Arm Type
Experimental
Arm Description
They performed training with a robot 15 times over 3 weeks.
Arm Title
Walking training
Arm Type
Experimental
Arm Description
Walking exercises were performed without a robot.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Physiotherapy treatment was carried out by the patients.
Intervention Type
Other
Intervention Name(s)
Learning to walk with a robot
Other Intervention Name(s)
ROB
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Walking group
Other Intervention Name(s)
WALK
Intervention Description
The walking protocol was performed without robotic assistance for 1 hour every day for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
CON
Intervention Description
The control group performed the physiotherapy treatment for 3 weeks.
Primary Outcome Measure Information:
Title
Modified Rankin Scale (mRS)
Description
stroke, diagnostic, quality of life
Time Frame
3 weeks (0-5 score, high score better)
Secondary Outcome Measure Information:
Title
Barthel Index for Activities of Daily Living (ADL)
Description
stroke quality of life
Time Frame
3 weeks
Title
Berg Balance Scale
Description
balance test
Time Frame
3 weeks (0-30, high score better)
Title
10-m maximal walking speed
Description
high speed test
Time Frame
3 weeks
Title
6MWT
Description
walking test
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dr. Tollár József
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
12. IPD Sharing Statement
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=soft%20exoskeleton&page=3
Description
Related Info
Learn more about this trial
Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients
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