Investigation of the Effects of Robot Assisted Gait Training With Virtual Reality on Cognitive Functions in Stroke Patients

November 11, 2022 updated by: Murat Akıncı, Ankara Yildirim Beyazıt University

Investigation of the Effects of Virtual Reality Exercises Combined With Robot-assisted Walking Training on Individuals With Subacute Stroke on Cognitive Functions, Activities of Daily Living and Quality of Life.

It was planned to examine the effects of robot-assisted walking training supported by virtual reality on cognitive functions, quality of life and activities of daily living in individuals with subacute stroke. In this context, only conventional physiotherapy was applied to one group, while the other group was given exercises with Lokomat in addition to conventional physiotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

According to the definition of the World Health Organization, stroke is a clinical syndrome characterized by the rapid establishment of signs and symptoms of focal loss of cerebral function for no apparent reason other than vascular causes. Symptoms last longer than twenty-four hours or may result in death. Stroke is the second leading cause of death in the world and the first cause of disability and loss of work force. Many stroke survivors are dependent on someone else for some part of their daily lives, have limitations in their daily and social activities, and have significantly lost their quality of life. Cognitive disorders after stroke are manifested by difficulties in information processing due to brain damage. The most common cognitive effects in stroke; attention, memory, orientation, executive dysfunction and aphasia.

For cognitive rehabilitation it is known that Lokomat combined virtual reality applications is more effective than Lokomat exercises without virtual reality in individuals with chronic stroke. Our research aims to contribute to the literature by revealing the cognitive functions, ADL and quality of life of locomotive exercises together with virtual reality in individuals with subacute stroke.

Our research will be carried out in the Robotic Rehabilitation Laboratory of Physical Therapy and Rehabilitation Hospital in Ankara City Hospital. The population of the study is the stroke clinics of the same hospital. Individuals with subacute stroke who volunteered to participate in the study will be included in the study. All patients will receive conventional physiotherapy five days a week for six weeks, and the study group will receive with Lokomat three times a week in addition to conventional physiotherapy. The patients will be evaluated by a therapist other than the practitioner before and after the treatment in two groups, one of which is the study group and the other is the control group.

Study Type

Observational

Enrollment (Anticipated)

28

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
      • Ankara, Turkey, 06000
        • Recruiting
        • Ankara City Hospital
        • Contact:

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The research will be carried out with individuals with subacute stroke. Participation in the research is based on a voluntary basis.

Description

Inclusion Criteria:

  • First Stroke
  • Subacut stroke (from 21 days to 180 days)
  • Can do Lokomat exercises

Exclusion Criteria:

  • incompatibility to lokomat (Femur lenght problems, severe cognitive impairment, excess weight etc.)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Other: Conventional Physiotherapy
Conventional physiotherapy includes stretching, strengthening, balance, coordination and walking exercises under the guidance of a physiotherapist.
Study Group
Device: Lokomat Augmented Performance Feedback
All participants will exercise with Lokomat Augmented Performance Feedback for six weeks. Augmented Performance Feedback has different virtual reality games.
Other: Conventional Physiotherapy
Conventional physiotherapy includes stretching, strengthening, balance, coordination and walking exercises under the guidance of a physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MOCA Score
Time Frame: 6 weeks after treatment
Montreal Cognitive Assessment (MOCA) assesses eight cognitive functions. These are attention and concentration, executive functions, memory, language, visual structuring, abstract thinking, computation, and orientation.
6 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lawton&Brody Score
Time Frame: 6 weeks after treatment
Instrumental Activities of Daily Living (Lawton&Brody Score) consists of 8 questions covering activities such as using the phone, shopping, using public transport, doing daily housework, preparing meals, and traveling. If the patient score is between 0-8 points, fully dependent, between 9-16 points semi-dependent, between 17-24 points is considered fully independent.
6 weeks after treatment
SS-QOL Score
Time Frame: 6 weeks after treatment
The Stroke-Specific Quality of Life Scale is specially designed for stroke patients. It consists of 49 items covering 12 domains that measure quality of life. It measures in many fields such as upper extremity functions, visual functions, speech, domestic roles, social roles, mobility, psychological state, work productivity, self-care, perception, memory, and personality. High scores indicate better quality of life. The maximum score is 245.
6 weeks after treatment

Collaborators and Investigators

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

Sponsor

Ankara Yildirim Beyazıt University

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)

August 17, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

November 5, 2022

First Submitted That Met QC Criteria

November 5, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lokomat Cognitive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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