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

NCT06715098 | Completed

• 1 other identifier: PamukkaleU.ftr-FArdıç-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Stroke; RehaWalk; RoboGait

Outcome Measures

Primary Outcomes (3)

• Gait analysis with 2D camera

  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)

  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

  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 Outcomes (3)

• 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 Arms (3)

RoboGait group

EXPERIMENTAL

Robotic walking training 3 days a week, 30 minutes a day for 4 weeks

Device: RoboGait

RehaWalk group

EXPERIMENTAL

Walking training on treadmill with body weight support for 30 minutes a day, 3 days a week for 4 weeks

Device: RehaWalk

Conventional Group

ACTIVE COMPARATOR

Conventional walking training for 30 minutes a day, 3 days a week for 4 weeks

Other: Conventional

Interventions

RoboGait DEVICE

RoboGait: robotic-assisted gait training

RoboGait group

RehaWalk DEVICE

RehaWalk: body weight-supported treadmill training

RehaWalk group

Conventional OTHER

Conventional: conventional walking training

Conventional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

Related Publications (29)

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MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Füsun Ardıç, Professor

  Pamukkale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: December 4, 2024
• Study Start: December 14, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 28, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)