Effects of Different Doses of Virtual Reality Therapy in Chronic Stroke Patients

NCT07656987 | Completed

• 1 other identifier: 2025/28
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effects of different doses of Wii Fit-based virtual reality (VR) therapy added to conventional rehabilitation in patients with chronic stroke. Forty-three patients were randomly assigned to three groups: a control group receiving conventional rehabilitation only (5 days/week, 45 min/session for 4 weeks), a VR3 group receiving conventional rehabilitation plus VR training three days per week (20 min/session, 12 sessions total), and a VR5 group receiving conventional rehabilitation plus VR training five days per week (20 min/session, 20 sessions total). Balance (Berg Balance Scale), functional independence (Functional Independence Measure), stroke-specific quality of life (SS-QOL), static postural alignment (Becure Posture Mobile), and center of pressure measurements (Becure Balance System) were assessed before treatment (T0), after treatment (T1), and at one-month follow-up (T2). This prospective, single-blind, randomized controlled trial was conducted at Istanbul Physical Medicine Rehabilitation Training and Research Hospital.

Conditions

Stroke; Chronic Stroke

Keywords

Virtual Reality; Wii Fit; Balance; Postural Control; Functional Independence; Quality of Life; Dose-Response; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  A 14-item clinical assessment tool measuring static and dynamic balance. Each item is scored 0-4; total score ranges from 0 to 56, with higher scores indicating better balance performance. The minimal clinically important difference (MCID) is 6 points for stroke patients.

  Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)

Secondary Outcomes (4)

• Functional Independence Measure (FIM)

  Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)

• Stroke-Specific Quality of Life Scale (SS-QOL)

  Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)

• Static Balance Assessment - Center of Pressure (Becure Balance System)

  Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)

• Static Postural Alignment (Becure Posture Mobile)

  Baseline (T0), post-treatment at 4 weeks (T1), and one-month follow-up (T2)

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Participants received conventional physiotherapy and rehabilitation only (45 min/session, 5 days/week, 4 weeks), including neurodevelopmental treatment, strengthening, and balance exercises. No virtual reality training was applied. (n=14)

Behavioral: Conventional Physiotherapy and Rehabilitation

VR3 Group

EXPERIMENTAL

Participants received conventional physiotherapy (45 min/session, 5 days/week, 4 weeks) plus Wii Fit-based virtual reality balance training 3 days/week (20 min/session, 12 sessions total). (n=15)

Behavioral: Wii Fit-Based Virtual Reality Balance Training; Behavioral: Conventional Physiotherapy and Rehabilitation

VR5 Group

EXPERIMENTAL

Participants received conventional physiotherapy (45 min/session, 5 days/week, 4 weeks) plus Wii Fit-based virtual reality balance training 5 days/week (20 min/session, 20 sessions total). (n=14)

Behavioral: Wii Fit-Based Virtual Reality Balance Training; Behavioral: Conventional Physiotherapy and Rehabilitation

Interventions

Wii Fit-Based Virtual Reality Balance Training BEHAVIORAL

Nintendo Wii Balance Board-based virtual reality balance training delivered using the Becure Balance System (modified with four 16-bit pressure sensors). Sessions lasted 20 minutes. VR3 group received 3 sessions/week (12 total); VR5 group received 5 sessions/week (20 total) over 4 weeks. Games were applied at beginner difficulty for the first 2 weeks and advanced difficulty for the final 2 weeks, with 2 repetitions per game. All sessions were supervised by a physiotherapist.

Also known as: Exergaming

VR3 Group; VR5 Group

Conventional Physiotherapy and Rehabilitation BEHAVIORAL

Conventional physiotherapy program including neurodevelopmental treatment, strengthening, and balance exercises. Applied to all three groups for 45 min/session, 5 days/week, over 4 weeks. Supervised by a physiotherapist.

Control Group; VR3 Group; VR5 Group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of ischemic or hemorrhagic stroke confirmed by CT or MRI
• Chronic stroke (onset ≥ 6 months prior to enrollment)
• Age between 20 and 75 years
• Mini-Mental State Examination (MMSE) score ≥ 18 (or MMSE-E for illiterate patients)
• Willingness to participate and provide written informed consent

You may not qualify if:

• Mini-Mental State Examination (MMSE) score \< 18
• Diagnosis of epilepsy
• Diagnosis of intellectual disability
• Visual and/or hearing impairment at a level that would affect participation in treatment methods

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, BAHCELIEVLER, 34188, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Exergaming; Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fatma Nur Kesiktaş, MD, PhD

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Resident

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 18, 2026
• Study Start: August 15, 2025
• Primary Completion: April 10, 2026
• Study Completion: April 10, 2026
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)