Clinical trial NCT06715098: Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training Using Gait Analysis and SEMG Measurements
Official title: Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training in Chronic Stroke Patients Using Gait Analysis and SEMG Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Keywords: Stroke
RehaWalk
RoboGait
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our randomized controlled clinical trial was to analyze the effects of robotic-assisted gait training and body-weight-supported treadmill training on gait analysis parameters and lower extremity agonist and antagonist muscle activities in stroke patients and to compare their effectiveness in improving locomotor function. The main questions that the researchers aimed to answer are: What are the effects of robotic-assisted gait training and body-weight-supported treadmill training on gait analysis parameters in stroke patients? What are the effects of robotic-assisted gait training and body-weight-supported treadmill training on lower extremity agonist and antagonist muscle activities in stroke patients? What is the effectiveness of robotic-assisted gait training and body-weight-supported treadmill training in improving locomotor function in stroke patients? The patients included in the study were randomly divided into three groups: The first group received robotic-assisted gait training with RoboGait, the second group received body-weight-supported gait training on a treadmill with RehaWalk, and the third group received conventional walking training.


Eligibility criteria: Inclusion Criteria:

* Age 18 and above
* Chronic stage stroke (6 months - 2 years)
* First stroke
* Spasticity of Ashworth stage 2 or lower
* Ability to follow commands
* Ability to walk unsupported for more than 10 meters
* No treatment received in the last month

Exclusion Criteria:

* Severe osteoporosis
* Unstable fracture
* Excessive spasticity (Ashworth stage 3 and above)
* Cognitive impairment

Primary outcomes:
measure: Gait analysis with 2D camera
timeFrame: Change from baseline kinematic parameters at the 4th week after the treatment
measure: Surface Electromyography (sEMG)
timeFrame: Change from baseline surface electromyography (sEMG) at the 4th week after the treatment
measure: Pressure and Walking Analysis
timeFrame: Change from baseline pressure and walking analysis at the 4th week after the treatment
Secondary outcomes:
measure: The Functional Ambulation Scale (FAS)
timeFrame: Change from baseline FAS at the 4th week after the treatment
measure: For lower extremity, the Fugl-Meyer Assessment (FMA-LE)
timeFrame: Change from baseline FMA-LE at the 4th week after the treatment
measure: The 6-minute walk test (6MWT)
timeFrame: Change from baseline 6MWT at the 4th week after the treatment
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Füsun Ardıç, Professor
role: STUDY_DIRECTOR
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