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Clinical Trials/NCT06715098
NCT06715098
Completed
Not Applicable

Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training in Chronic Stroke Patients Using Gait Analysis and SEMG Measurements

Pamukkale University1 site in 1 country45 target enrollmentDecember 14, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Pamukkale University
Enrollment
45
Locations
1
Primary Endpoint
Gait analysis with 2D camera
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2023
End Date
September 28, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Füsun Ardıç

Professor Doctor

Pamukkale University

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

Outcomes

Primary Outcomes

Gait analysis with 2D camera

Time Frame: Change from baseline kinematic parameters at the 4th week after the treatment

Kinematic parameters: Hip joint flexion range of motion degree in the swing phase in the sagittal plane, knee joint maximum flexion angle degree, ankle joint dorsiflexion range of motion degree

Surface Electromyography (sEMG)

Time Frame: Change from baseline surface electromyography (sEMG) at the 4th week after the treatment

The average EMG (AEMG) amplitude and co-contraction indices (CCI) are calculated for the affected lower extremity's knee flexion and ankle dorsiflexion during the swing phase. CCI is calculated using the formula antagonistic muscle AEMG / (antagonistic muscle AEMG + agonistic muscle AEMG)

Pressure and Walking Analysis

Time Frame: Change from baseline pressure and walking analysis at the 4th week after the treatment

The researchers examined the effects such as walking line length, single support line, forward and backward rollers and lateral symmetry indexes in the pressure analyses. In the gait analysis, walking speed, cadence, step length, step width, foot rotation angle, step duration, double support duration, stance phase, swing phase, single support phase, pre-swing phase, mid-swing phase, terminal swing phase, stance duration, swing duration, double phase, double step length and temporal symmetry index were evaluated. The temporal symmetry index was calculated using the following formula: Swing duration of the affected side of the patient / Swing duration of the unaffected side of the patient

Secondary Outcomes

  • The Functional Ambulation Scale (FAS)(Change from baseline FAS at the 4th week after the treatment)
  • For lower extremity, the Fugl-Meyer Assessment (FMA-LE)(Change from baseline FMA-LE at the 4th week after the treatment)
  • The 6-minute walk test (6MWT)(Change from baseline 6MWT at the 4th week after the treatment)

Study Sites (1)

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