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

Not Applicable

Completed

• Conditions: Stroke, Ischemic

• Registration Number: NCT06715098
• Lead Sponsor: Pamukkale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Study First Submitted: 2024-07-12
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-28
• Status Verified: 2024-11
• Study First Submitted QC: 2024-12-01
• Last Update Submitted: 2024-12-01
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait analysis with 2D camera	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)	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	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 Outcome Measures

Name	Time	Method
The Functional Ambulation Scale (FAS)	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.
For lower extremity, the Fugl-Meyer Assessment (FMA-LE)	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.
The 6-minute walk test (6MWT)	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.

Trial Locations

Locations (1)

Pamukkale University; 🇹🇷 Denizli, Turkey