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

NCT05869786 | Completed FDA Device

• 1 other identifier: 2023.04.43
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer upper extremity scale

  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.

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

Secondary Outcomes (4)

• Functional Independence Measure

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

• Handgrip Strength

  Change from Baseline Handgrip Strength at 3rd Month After Intervention

• Modified Ashworth Scale

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

• Stroke Impact Scale

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

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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 (450 minutes in total). 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.

Device: Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®); Other: conventional rehabilitation program

Control Group

ACTIVE COMPARATOR

Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. Participants in both groups will receive a conventional rehabilitation program.

Other: conventional rehabilitation program; Behavioral: Exercise

Interventions

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.

Virtual Reality Group

conventional rehabilitation program OTHER

conventional rehabilitation program

Control Group; Virtual Reality Group

Exercise BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Ahmet Kıvanç Menekşeoğlu

Istanbul, 34015, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• AHmet Kivanc Menekseoglu, MD

  Kanuni Sultan Suleyman Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)