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Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Robot
Fizio
EXE1
EXE2
EXE+ROB
Sponsored by
Somogy Megyei Kaposi Mór Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring robotic, stroke, rehabilitation, virtual rehabilitation

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Robotic

Fizio

EXE1

EXE2

EXE+ROB

Arm Description

They performed training with a robot 15 times over 3 weeks.

They receive physiotherapy treatment.

Virtual reality treatment is performed once a day.

Virtual reality treatment is performed twice a day.

Virtual and robotic treatments are performed once a day.

Outcomes

Primary Outcome Measures

mRS score

Secondary Outcome Measures

Barthel index score
Berg balance score
6MWT
meter
10m gait speed
m/s

Full Information

First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05985889
Brief Title
Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients
Official Title
Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 8, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 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 perform a comparison of several groups. We would like to determine how robotic and virtual therapy is most effective in the treatment of stroke patients. We place great emphasis on walking speed, quality of life, coordination and changes in walking distance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
robotic, stroke, rehabilitation, virtual rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic
Arm Type
Experimental
Arm Description
They performed training with a robot 15 times over 3 weeks.
Arm Title
Fizio
Arm Type
Experimental
Arm Description
They receive physiotherapy treatment.
Arm Title
EXE1
Arm Type
Experimental
Arm Description
Virtual reality treatment is performed once a day.
Arm Title
EXE2
Arm Type
Experimental
Arm Description
Virtual reality treatment is performed twice a day.
Arm Title
EXE+ROB
Arm Type
Experimental
Arm Description
Virtual and robotic treatments are performed once a day.
Intervention Type
Other
Intervention Name(s)
Robot
Other Intervention Name(s)
ROB
Intervention Description
You have to walk with a robot mounted on your lower limb. To move, to change direction.
Intervention Type
Other
Intervention Name(s)
Fizio
Intervention Description
Patients do state-funded physical therapy.
Intervention Type
Other
Intervention Name(s)
EXE1
Intervention Description
Patients undergo intensive virtual reality therapy once a day.
Intervention Type
Other
Intervention Name(s)
EXE2
Intervention Description
Patients undergo intensive virtual reality therapy twice a day.
Intervention Type
Other
Intervention Name(s)
EXE+ROB
Intervention Description
The patients intensively performed 1 virtual reality therapy and 1 robotic therapy every day.
Primary Outcome Measure Information:
Title
mRS score
Time Frame
3 weeks (0-5 score, high score better)
Secondary Outcome Measure Information:
Title
Barthel index score
Time Frame
3 weeks
Title
Berg balance score
Time Frame
3 weeks (0-30, high score better)
Title
6MWT
Description
meter
Time Frame
3 weeks
Title
10m gait speed
Description
m/s
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

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=soft+exosuit
Description
Related Info

Learn more about this trial

Comparison of Innovative Rehabilitation Treatments and Examination of Their Effectiveness in Stroke Patients

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