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Completed

NCT Number: NCT06715098

Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training Using Gait Analysis and SEMG Measurements

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RoboGait

Device

RoboGait: robotic-assisted gait training

RehaWalk

Device

RehaWalk: body weight-supported treadmill training

Conventional

Other

Conventional: conventional walking training

Primary outcomes

  1. 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

  2. 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)

  3. 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

  1. The Functional Ambulation Scale (FAS)

    Time frame: Change from baseline FAS at the 4th week after the treatment

    The Functional Ambulation Scale (FAS) is a scale used to assess the level of ambulation in patients. It is divided into six categories graded from 0 to 5: FAS 0: no ambulation, FAS 1-2: unable to walk without assistance, FAS 3-5: able to walk 6 meters independently.

  2. For lower extremity, the Fugl-Meyer Assessment (FMA-LE)

    Time frame: Change from baseline FMA-LE at the 4th week after the treatment

    For lower extremity, the Fugl-Meyer Assessment (FMA-LE) was used in our study, consisting of a total of 17 items with a maximum score of 34 points. The scale assesses reflexes, synergy-dependent or synergy-independent voluntary movements, coordination, and speed. Each item is scored between 0 and 2 points, with a higher score indicating better outcomes.

  3. The 6-minute walk test (6MWT)

    Time frame: Change from baseline 6MWT at the 4th week after the treatment

    In the 6-minute walk test (6MWT), researchers asked participants to walk down a 30-meter hospital hallway at their own pace for 6 minutes, following standard instructions to cover as much distance as possible. The distance walked was recorded in meters.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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