Clinical trial NCT04033185: To Investigate the Effects of Robotic-assisted Gait Training in Stroke Patients
Official title: Investigation Of The Effects Of Virtual Reality Application With Robotic Rehabilitation In Patients With Chronic Stroke.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Keywords: joint position sense
stroke
virtual reality
robot assisted gait training
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study was to investigate the effects of robot-assisted gait training and virtual reality on knee joint position sense in patients with chronic stroke. The secondary objective is to examine the effectiveness of these applications on functional gait and balance.

Detailed description: Despite widespread prevention programs worldwide and advances in acute and subacute management and treatment protocols, stroke remains one of the most common causes of adult disability, representing a serious global health problem. Sensory motor dysfunction, proprioception deficits and hypertonus may develop in stroke patients depending on the location and severity of the brain damaged areas. Virtual reality application, which has been widely used in recent years, is a three-dimensional, computer-generated technology that gives the patient a sense of reality and allows the patient to interact with it. Virtual reality application can be used as a suitable method for proprioceptive rehabilitation due to its ability to manipulate visual feedback of virtual objects. In recent years, another technological method that has been used in the field of neurorehabilitation is robotic rehabilitation. Robot-assisted gait training, which requires repetitive tasks, can enhance neuroplasticity and motor learning, which focuses on the rearrangement of brain tissue. Both technology-based rehabilitation approaches have been shown to be particularly effective in improving the sense of position in the upper extremity. However, studies investigating the effects of these two applications on lower extremity position sensation seem to be insufficient. We think that both methods will be effective in improving the sense of position.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with stroke by specialist physician,
* 6 months after stroke diagnosis,
* Hemiplegia or hemiparesis due to stroke for the first time,
* Being over 18,
* Being able to walk with auxiliary device or independently,
* Mini Mental test score\> 24,
* Functional Ambulation Classification FAC ≥ 2,
* Agree to participate in the study.

Exclusion Criteria:

* Acute internal discomfort,
* Botulinum toxin administration during 6 months before treatment or during treatment,
* Presence of a history of previous stroke,
* Having influence on both sides,
* Neglect syndrome,
* Presence of severe spasticity (Modified Ashwort Scale\> 2),
* Patients weighing more than 100 kg,
* Patients with femoral lengths greater than 50cm

Primary outcomes:
measure: functional ambulation classification (FAC)
timeFrame: Before treatment
measure: Activity-Specific Balance Safety Scale
timeFrame: change from baseline score at the end of 5 weeks
measure: Modified Ashworth Scale
timeFrame: Before treatment
measure: Modified Rankin Scale
timeFrame: change from baseline score at the end of 5 weeks
measure: Stroke Rehabilitation Movement Assessment Scale- STREAM
timeFrame: change from baseline score at the end of 5 weeks
measure: Time up and go test
timeFrame: change from baseline time at the end of 5 weeks
measure: Mobile Phone-Based Joint Angle Measurement
timeFrame: change from baseline angle at the end of 5 weeks
measure: Berg Balance Scale
timeFrame: change from baseline score at the end of 5 weeks
measure: goniometric measurement
timeFrame: change from baseline angle at the end of 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nevsehir
country: Turkey
facility: Kozaklı Physical Therapy and Rehabilitation Hospital
state: Kozakli
Study officials:
affiliation: Gazi University
name: Arzu Güçlü Gündüz, prof.
role: STUDY_DIRECTOR
References: