Exoskeleton DeviceNCT05614141
Investigation of the Effects of Robot Assisted Gait Training With Virtual Reality on Cognitive Functions in Stroke Patients
An observational study of Exoskeleton Device and Locomotion, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exoskeleton Device, Locomotion, Stroke
- What is being tested?
- Lokomat Augmented Performance Feedback and Conventional Physiotherapy
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Aug 2022to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The research will be carried out with individuals with subacute stroke. Participation in the research is based on a voluntary basis.
Who may be able to join
- First Stroke
- Subacut stroke (from 21 days to 180 days)
- Can do Lokomat exercises
Who cannot join
- incompatibility to lokomat (Femur lenght problems, severe cognitive impairment, excess weight etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara, 06000
Murat 1 AKINCI, 1, +(90) 552 935 69 78 ext. 900312, muratakinci.fzt@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Exoskeleton Device, Locomotion, Stroke
- Being tested
- Lokomat Augmented Performance Feedback, Conventional Physiotherapy
- Keywords
- Lokomat, Augmented Performance Feedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat Augmented Performance FeedbackDevice
All participants will exercise with Lokomat Augmented Performance Feedback for six weeks. Augmented Performance Feedback has different virtual reality games.
Conventional PhysiotherapyOther
Conventional physiotherapy includes stretching, strengthening, balance, coordination and walking exercises under the guidance of a physiotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Not described Receives: Device: Lokomat Augmented Performance Feedback; Other: Conventional Physiotherapy | |
| Control Group | Not described Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCA Score
Montreal Cognitive Assessment (MOCA) assesses eight cognitive functions. These are attention and concentration, executive functions, memory, language, visual structuring, abstract thinking, computation, and orientation.
Measured: 6 weeks after treatment
Secondary outcomes (2)
Lawton&Brody Score
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.
Measured: 6 weeks after treatment
SS-QOL Score
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.
Measured: 6 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start17 Aug 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exoskeleton DeviceStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Akıncı, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614141
- Sponsor's protocol ID
- Lokomat Cognitive
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05614141
- Acronym / sponsor ID
- Lokomat Cognitive
- Conditions
- Exoskeleton Device, Locomotion, Stroke
- Keywords
- Lokomat, Augmented Performance Feedback
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Device: Lokomat Augmented Performance Feedback, Other: Conventional Physiotherapy |
| Control Group | – | Other: Conventional Physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The research will be carried out with individuals with subacute stroke. Participation in the research is based on a voluntary basis.
Key inclusion criteria (3 listed)
- First Stroke
- Subacut stroke (from 21 days to 180 days)
- Can do Lokomat exercises
Key exclusion criteria (1 listed)
- incompatibility to lokomat (Femur lenght problems, severe cognitive impairment, excess weight etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lokomat Augmented Performance FeedbackAll participants will exercise with Lokomat Augmented Performance Feedback for six weeks. Augmented Performance Feedback has different virtual reality games. | Device | Study Group |
| Conventional PhysiotherapyConventional physiotherapy includes stretching, strengthening, balance, coordination and walking exercises under the guidance of a physiotherapist. | Other | Control Group, Study Group |
Primary outcome
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.
2 secondary outcomes
Lawton&Brody Score
Time frame: 6 weeks after treatment
SS-QOL Score
Time frame: 6 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Exoskeleton Device and Locomotion, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOCA Score (time frame: 6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.