The Effects of Lokomat Virtual Reality Applications on Balance and Gait in Stroke Patients

NCT05419791 | Completed

• 1 other identifier: Lokomat VR
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The effectiveness of applying robot-assisted walking training together with conventional physiotherapy is widely accepted. Virtual reality is another component and its contribution to rehabilitation is important. When we look at the literature on virtual reality applications on balance and walking, it is seen that some systems are beneficial while some systems have no effect. This raises the possibility that virtual reality applications may produce different results due to the task in the exercise, patient motivation or any other reason. There is a need to investigate whether virtual reality applications have different effects, if any, what is the source of this and what care should be taken in the development of these applications in the future. Therefore, we focused on investigating the different effects of Lokomat virtual reality applications.

Conditions

Stroke

Keywords

Augmented performance feedback; Lokomat; Stroke; Rehabilitation; Virtual Reality

Outcome Measures

Primary Outcomes (5)

• Change in 6 MWT

  6 Minutes Walk Test is a test using for walking distance. We evaluated the change in walking distance with 6 MWT.

  6 weeks after treatment

• Change in 10 MWT

  10 MWT is a test using for evaluate the gait speed. Gait speed is a spatiotemporal parameter.

  6 weeks after treatment

• Change in BBS

  Berg Balance Scale used for balance assesment. The scale consists of 14 items and each item gets a score between 0-4. As a result, the person evaluated gets a score between 0-56 on the berg balance scale. A higher score means the person has better balance skills.

  6 weeks after treatment

• Change in Limits of Stability

  Limits of Stability (LoS) are defined as the points at which the center of gravity (CoG) approaches the limits of the base of support (BoS) and a correction strategy is required to return the center of mass (CoM) to within the BoS. In other words, LoS is the amount of maximum excursion an individual is able to intentionally cover in any direction without losing his/her balance or taking a step. We used Huber 360 device to evaluate the LoS.

  6 weeks after treatment

• Change in Spatiotemporal Gait Analysis

  Spatiotemporal gait analysis gives spatial (distance) parameters along with temporal (time) parameters. * Spatial parameters: * Step Length * Step Width * Stride Length * Temporal Parameters * Step Time * Stride Time * Stance Time * Swing Time * Double Support Time We used C-Mill device to evaluate the spatiotemporal parameters.

  6 weeks after treatment

Secondary Outcomes (3)

• Change in Spatial Symmetry

  6 weeks after treatment

• Change in Temporal Symmetry

  6 weeks after treatment

• Change in Postural Stability

  6 weeks after treatment

Study Arms (4)

Lokomat Group I (Endurance)

EXPERIMENTAL

* Faster application used with Lokomat gait training * Conventional Physiotherapy

Other: Robot Asisted Gait Training with Lokomat (Endurance); Other: Conventional Physiotherapy

Lokomat Group II (Attention and Motivation)

EXPERIMENTAL

* Smile and Gabarello applications used with Lokomat gait training * Conventional Physiotherapy

Other: Robot Asisted Gait Training with Lokomat (Attention and Motivation); Other: Conventional Physiotherapy

Lokomat Group III (Activity Timing)

EXPERIMENTAL

* High Flyer, Curve Pursuit and Treasures applications used with Lokomat gait training * Conventional Physiotherapy

Other: Robot Asisted Gait Training with Lokomat (Activity Timing); Other: Conventional Physiotherapy

Control

OTHER

-Only Conventional Physiotherapy

Other: Conventional Physiotherapy

Interventions

Robot Asisted Gait Training with Lokomat (Endurance) OTHER

* Faster application (using for Endurance) : 3 days in a week for 6 weeks,very season was 40 min. * Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Lokomat Group I (Endurance)

Robot Asisted Gait Training with Lokomat (Attention and Motivation) OTHER

* Smile application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min. * Gabarello application (using for Attetion and Motivation) : 3 days in a week for 6 weeks,very season was 20 min. * Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Lokomat Group II (Attention and Motivation)

Robot Asisted Gait Training with Lokomat (Activity Timing) OTHER

* High Flyer application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 20 min. * Treasures application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min. * Curve Pursuit application (using for Activity Timing) : 3 days in a week for 6 weeks,very season was 10 min. * Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Lokomat Group III (Activity Timing)

Conventional Physiotherapy OTHER

-Conventional Physiotherapy : 5 days in a week for 6 weeks, every seanson was 40 min.

Control; Lokomat Group I (Endurance); Lokomat Group II (Attention and Motivation); Lokomat Group III (Activity Timing)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Only men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis is stroke
• The time period have to be chronic period (+6 months)
• The patient must have the ability to walk with or without support
• The patiens should be able to understand Lokomat exercises

You may not qualify if:

• Any condition that may prevent walking with Lokomat
• Not volunteering to participate in the study

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead
• Ankara City Hospital Bilkent: collaborator

Study Sites (1)

Ankara City Hospital

Ankara, 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor has been masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Individuals have been assigned to groups by Research Randomizer program.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 15, 2022
• Study Start: November 11, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

TU (1)