Virtual Reality Based Robotic Gait and Balance Trainer

NCT06164197 | Completed

• 1 other identifier: RAGT03
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of research is to examine and compare the effectiveness of virtual reality-based balance training and robot-assisted walking approaches on balance and gait in individuals post-stroke. Through the study, Investigators intend to reach conclusions regarding whether the focus should be on balance or walking training based on the Berg Balance Scale and Functional Ambulation Classification levels of stroke survivors. Subgroups will be formed in both groups based on Functional Ambulation and Berg Balance Scale scores. The balance and gait developments within these subgroups will be compared, aiming to determine at which levels balance or walking improvement is more pronounced. These findings are crucial for making the right choices in setting rehabilitation goals for individual patients.

Conditions

Stroke

Keywords

Stroke; Virtual Reality; Lokomat; Thera-Trainer; Balance-Trainer; Robot Assisted Gait Training; Robotics

Outcome Measures

Primary Outcomes (2)

• Berg Balance Scale

  This is a simple and safe balance test designed to measure an individual's ability to maintain balance while performing functional tasks. The person is asked to perform 14 tasks, and scores are given based on the completion of each task. A score of 0 is assigned when the activity is not performed at all, while a score of 4 is given when the activity is completed independently. The highest possible score is 56, with 0-20 indicating balance impairment, 21-40 suggesting an acceptable balance, and 41-56 indicating good balance.

  Baseline and After last treatment seasion

• Spatiotemporal Gait Analysis

  In our research, spatiotemporal gait analysis will be conducted using the CMill VR+ device. As a result of gait analysis, parameters such as step lengths, swing, stance and double support phases, cadence, and levels of weight shifting to each side during walking will be recorded.

  Baseline and After last treatment seasion

Secondary Outcomes (2)

• Functional Independence Measure

  Baseline and After last treatment seasion

• Functional Ambulation Category

  Baseline and After last treatment seasion

Other Outcomes (1)

• Patient Satisfaction

  After last treatment seasion

Study Arms (2)

Lokomat

EXPERIMENTAL

Device: Lokomat; Other: Person-Specific Rehabilitation Program

Balance Trainer

EXPERIMENTAL

Device: Thera Trainer Balo; Other: Person-Specific Rehabilitation Program

Interventions

Lokomat DEVICE

Robot Assisted Gait Training

Lokomat

Thera Trainer Balo DEVICE

Virtual Reality Based Balance Training Device

Balance Trainer

Person-Specific Rehabilitation Program OTHER

Person-Specific Rehabilitation Program

Balance Trainer; Lokomat

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having the ICD-10 diagnosis code G.81 Hemiplegia
• At least 3 weeks having passed since the diagnosis (Subacute and cronic periods)
• Being 18 years of age or older
• Having a Berg Balance Score between 21-40 (indicating an acceptable balance)
• Being able to walk with or without support (FAC score of 2 or higher)

You may not qualify if:

• Having a known additional neurological or orthopedic problem that could affect balance
• Inability to adapt to virtual reality applications in Lokomat and Balance Trainer
• Diagnosis being more than 2 years old

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 11, 2023
• Study Start: August 23, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2023-12

Locations

TU (1)