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

December 1, 2024 updated by: Füsun Ardıç, Pamukkale University

Comparison of Robot Assisted Gait Training and Body Weight Supported Treadmill Training in Chronic Stroke Patients 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RoboGait group
Robotic walking training 3 days a week, 30 minutes a day for 4 weeks
Device: RoboGait
RoboGait: robotic-assisted gait training
Experimental: RehaWalk group
Walking training on treadmill with body weight support for 30 minutes a day, 3 days a week for 4 weeks
Device: RehaWalk
RehaWalk: body weight-supported treadmill training
Active Comparator: Conventional Group
Conventional walking training for 30 minutes a day, 3 days a week for 4 weeks
Other: Conventional
Conventional: conventional walking training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline kinematic parameters at the 4th week after the treatment
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)
Change from baseline surface electromyography (sEMG) at the 4th week after the treatment
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
Change from baseline pressure and walking analysis at the 4th week after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline FAS at the 4th week after the treatment
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.
Change from baseline FMA-LE at the 4th week after the treatment
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.
Change from baseline 6MWT at the 4th week after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Study Director: Füsun Ardıç, Professor, Pamukkale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2023

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

September 28, 2024

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

December 1, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 1, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PamukkaleU.ftr-FArdıç-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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