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

Hemiplegia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05869786
• Other study ID #: 2023.04.43
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Ischemic Stroke

Intervention

Device:
• Virtual 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.

Other:
• conventional rehabilitation program
conventional rehabilitation program

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

Locations

Country	Name	City	State
Turkey	Ahmet Kivanç Menekseoglu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Independence Measure	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.	Change from Baseline Functional Independence Measure at 3rd Month After Intervention
Secondary	Handgrip Strength	The handgrip strength of the participants will be evaluated with a dynamometer.	Change from Baseline Handgrip Strength at 3rd Month After Intervention
Secondary	Modified Ashworth Scale	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.	Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention
Secondary	Stroke Impact Scale	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.	Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention