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NCT05947773 Clinical Trial

Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients

Stroke Clinical Trial

Official title:
Effect of Robotic Treatments on Motor Functions in Subacute Stroke Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05947773
Other study ID # IKEB/2022/02
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date July 9, 2023
Est. completion date September 1, 2023

Study information
Verified date August 2023
Source Somogy Megyei Kaposi Mór Teaching Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 45
Est. completion date September 1, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 55 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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)
• Walking group
The walking protocol was performed without robotic assistance for 1 hour every day for 3 weeks.
• Control group
The control group performed the physiotherapy treatment for 3 weeks.

Locations
Country Name City State
Hungary Dr. Tollár József Kaposvár Somogy

Sponsors (1)
Lead Sponsor Collaborator
Somogy Megyei Kaposi Mór Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Modified Rankin Scale (mRS) stroke, diagnostic, quality of life 3 weeks (0-5 score, high score better)
Secondary Barthel Index for Activities of Daily Living (ADL) stroke quality of life 3 weeks
Secondary Berg Balance Scale balance test 3 weeks (0-30, high score better)
Secondary 10-m maximal walking speed high speed test 3 weeks
Secondary 6MWT walking test 3 weeks
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