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The Effect of Virtual Reality-Mediated Rehabilitation in Ischemic Stroke Patients

Investigation of the Effect of Virtual Reality-Mediated Rehabilitation on Upper Extremity Functions in Ischemic Stroke Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05869786
Enrollment
32
Registered
2023-05-22
Start date
2023-05-01
Completion date
2024-01-01
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia

Brief summary

The aim of the study was to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation added to the conventional rehabilitation program on upper extremity, quality of life, range of motion and spasticity in patients with stroke.

Detailed description

This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PMR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group). Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (total 450 minutes). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day. Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. After the intervention, patients will be evaluated in terms of upper extremity functions, quality of life, range of motion and spasticity. All evaluations will be repeated before, after and 3 months after the intervention. Routine 3-month PMR outpatient clinic control is recommended for patients with stroke. Therefore, no additional hospital visit is requested from the patients due to the study.

Interventions

DEVICEVirtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)

In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves.

conventional rehabilitation program

BEHAVIORALExercise

Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PTR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group).

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 18 to 65 years of age, * History of Ischemic Stroke * Accept to participate in the study,

Exclusion criteria

* Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurologic deficit, * Uncontrolled hypertension, diabetes, cardiovascular disease etc. * Cognitive impairment causing difficulty in executing simple commands * Epilepsy * Botulinum toxin application to the upper extremity in the last 6 months * Change in the medical treatment used for spasticity in the last 6 months * Pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer upper extremity scaleChange from Baseline Fugl-Meyer upper extremity scale at 3rd Month After InterventionThis scale is a stroke-specific, performance-based scale and each parameter is scored as 0; unsuccessful, 1; partially successful and 2; completely successful performance. This scale consists of five sections: motor function, balance, sensation, range of motion and pain. The motor function assessment section is scored as 100 points (66 upper extremities and 34 lower extremities), sensation (light touch and position sense) 24 points, balance (6 sitting and 8 standing) 14 points, range of motion 44 points and joint pain 44 points.

Secondary

MeasureTime frameDescription
Modified Ashworth ScaleChange from Baseline Modified Ashworth Scale at 3rd Month After InterventionUpper extremity muscle spasticity of the participants will be evaluated with the modified Ashworth Scale. According to this scale, spasticity is evaluated between 0-4. Higher points mean more spasticity.
Functional Independence MeasureChange from Baseline Functional Independence Measure at 3rd Month After InterventionParticipants' functional status will be assessed by Functional Independence Measure. In this scale, the functional status of patients is evaluated with 18 questions under 6 sub-headings, each question is scored between 1-7. Higher scores indicate better functional status.
Handgrip StrengthChange from Baseline Handgrip Strength at 3rd Month After InterventionThe handgrip strength of the participants will be evaluated with a dynamometer.
Stroke Impact ScaleChange from Baseline Stroke Impact Scale. at 3rd Month After InterventionThe quality of life of the participants will be evaluated with the Stroke Impact Scale.It consists of 8 subsections and 59 questions. Each question is scored by rating the difficulty experienced in the last week on a 5-point scale. The score for each section ranges from 0-100. Higher scores are associated with better quality of life.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026