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Completed

NCT Number: NCT05869786

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

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.

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Key information

Conditions

Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmet Kıvanç Menekşeoğlu

Istanbul, 34015, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)

Device

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

Other

conventional rehabilitation program

Exercise

Behavioral

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

Primary outcomes

  1. Fugl-Meyer upper extremity scale

    Time frame: Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention

    This 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 outcomes

  1. Functional Independence Measure

    Time frame: Change from Baseline Functional Independence Measure at 3rd Month After Intervention

    Participants' 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.

  2. Handgrip Strength

    Time frame: Change from Baseline Handgrip Strength at 3rd Month After Intervention

    The handgrip strength of the participants will be evaluated with a dynamometer.

  3. Modified Ashworth Scale

    Time frame: Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention

    Upper 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.

  4. Stroke Impact Scale

    Time frame: Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention

    The 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 22, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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