The Effects of Augmented Reality Versus Virtual Reality

NCT07113093 | Recruiting

• 1 other identifier: VR02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effects of augmented reality (AR) and virtual reality (VR)-assisted treadmill gait training on balance and walking in individuals with stroke, within the framework of the International Classification of Functioning, Disability and Health (ICF). A total of 66 post-stroke patients will be randomly assigned to three groups: (1) VR group receiving gait training via C-Mill VR applications in addition to conventional physiotherapy, (2) AR group receiving gait training via C-Mill AR applications in addition to conventional physiotherapy, and (3) control group receiving a home exercise program alongside conventional physiotherapy. Participants will train for 45 minutes per day, five days a week, for three weeks. Outcome measures will include clinical, functional, cognitive, and spatiotemporal gait parameters to evaluate changes in balance and walking ability before and after the intervention.

Conditions

Stroke

Keywords

Stroke; Virtual Reality; Augmented Reality; Treadmill

Outcome Measures

Primary Outcomes (3)

• Timed Up and Go (TUG) Test

  To perform the test, the patient stands up from a chair approximately 46 cm in height, walks at a comfortable and safe pace to a marked target three meters away, turns around the target, and returns to sit back down on the chair. To ensure familiarity with the procedure, the patient performs one trial without timing. If needed, the patient may use their usual walking aid (e.g., cane or walker). A shorter completion time indicates better performance.

  baseline and after 3 weeks

• Berg Balance Scale (BBS)

  The scale consists of 14 items and assesses the patient's ability to maintain balance (either static or during various functional movements) over a specific period of time. Each item is scored on a scale from 0 to 4: 0 points: Unable to complete the task. 4 points: Completes the task independently. The maximum total score is 56. A score of 0-20 indicates poor balance, 21-40 indicates acceptable balance, and 41-56 indicates good balance.

  baseline and after 3 weeks

• Gait Analsis

  Spatio-temporal gait analysis will be performed using the C-Mill VR+ device. As a result of this measurement, step lengths, stance phases (%), swing phases (%), and double support phases (%) of the paretic and non-paretic limbs will be recorded. Gait analysis will be conducted in two separate assessments: at the participant's self-selected comfortable walking speed and at a fixed speed of 1 km/h. The gait analysis will begin after a 2-minute warm-up period, and data will be collected for the following 2 minutes. A rest period of at least 5 minutes will be provided between the two assessments.

  baseline and after 3 weeks

Secondary Outcomes (6)

• Fugl-Meyer Motor Assessment Lower Extremity (FMA-LE)

  baseline and after 3 weeks

• Activities-specific Balance Confidence (ABC) Scale

  baseline and after 3 weeks

• Functional Ambulation Category (FAC)

  baseline and after 3 weeks

• Trunk Impairment Scale (TIS)

  baseline and after 3 weeks

• Stroke Impact Scale (SIS) Version 3.0

  baseline and after 3 weeks

Other Outcomes (2)

• Modified Ashworth Scale (MAS)

  baseline and after 3 weeks

• Montreal Cognitive Assessment (MoCA)

  baseline and after 3 weeks

Study Arms (3)

Augmented Reality

EXPERIMENTAL

In this group, augmented reality will be used during treadmill walking.

Other: Augmented Reality; Other: Others

Virtual Reality

EXPERIMENTAL

In this group, virtual reality will be used during treadmill walking.

Other: Virtual Reality; Other: Others

Control Group

OTHER

Participants in this group will be enrolled in a self-directed exercise program that is matched in duration and content to the VR-AR interventions.

Other: Self Directed Exercises; Other: Others

Interventions

Augmented Reality OTHER

Gait training will be conducted using the AR applications Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game for 45 minutes.

Augmented Reality

Virtual Reality OTHER

Gait training will be conducted using the VR applications Nature Island, Italian Apps, and Soccer for 45 minutes.

Virtual Reality

Self Directed Exercises OTHER

"Patients will be taught exercises including walking on a flat surface, walking with varying step lengths, walking over obstacles, and walking at different speeds. They will be instructed to perform these exercises for 45 minutes per day.

Control Group

Others OTHER

The treatment duration is 60 minutes. Based on the patient's needs, the following exercises will be performed: scapular and thoracolumbar mobilization; upper and lower extremity exercises (range of motion, stretching, and strengthening); bed mobility and transitional movements such as rolling, coming to a sitting position, and standing up; core activation exercises such as bridging and functional reaching; weight shifting and balance training; gait training (e.g., walking between parallel bars, walking in different directions, and walking over obstacles); and cycling on a bicycle ergometer.

Augmented Reality; Control Group; Virtual Reality

Eligibility Criteria

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

You may qualify if:

• ICD-10 diagnosis code of G.81 (Hemiplegia)
• Age 18 years or older
• Ability to walk with assistance or independently (Functional Ambulation Classification score of 2 or higher)

You may not qualify if:

• Incomplete completion of the assessment form
• Refusal to participate in the study
• Aphasia
• Montreal Cognitive Assessment score below 10
• Presence of extra neurological or orthopedic problems unrelated to stroke
• Recurrent stroke
• MAS score of 3-4 (lower extremity)
• Volunteer's desire to withdraw from the study
• Inability to adapt to the technological devices used in the study (e.g., visual or hearing impairments)
• Missing three consecutive treatment sessions
• Botulinum toxin-A (BONT-A) injection to the lower extremity during the treatment process or within the last 6 months

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Bro protein, Drosophila

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Murat Akıncı, Msc

CONTACT

+905529356978; muratakinci.fzt@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 8, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-08

Locations

TU (1)