Clinical trial NCT05614141: Investigation of the Effects of Robot Assisted Gait Training With Virtual Reality on Cognitive Functions in Stroke Patients
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Exoskeleton Device
Locomotion
Stroke
Keywords: Lokomat
Augmented Performance Feedback
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: MOCA Score
timeFrame: 6 weeks after treatment
Secondary outcomes:
measure: Lawton&Brody Score
timeFrame: 6 weeks after treatment
measure: SS-QOL Score
timeFrame: 6 weeks after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
References: