About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Incomplete completion of the assessment form
Refusal to participate in the study
Aphasia
Montreal Cognitive Assessment score below 10
Trial design
Parallel
Treatments tested in this trial
Augmented Reality
Other interventionGait training will be conducted using the AR applications Stepping Stones, Reactive Stones, Obstacles, Speed Adjustment, Slalom, Tandem, and Monster Game for 45 minutes.
Virtual Reality
Other interventionGait training will be conducted using the VR applications Nature Island, Italian Apps, and Soccer for 45 minutes.
Self Directed Exercises
Other intervention"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.
Others
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
Fugl-Meyer Motor Assessment Lower Extremity (FMA-LE)
The FMA is a widely used, valid, and reliable test for evaluating motor impairments of the paretic upper and lower extremities in stroke patients. Each item on the scale is scored as follows: 0 = unable to perform, 1 = performs partially, and 2 = performs fully. Higher scores indicate better motor function. In this study, the 34-point lower extremity section of the scale will be used.
Activities-specific Balance Confidence (ABC) Scale
The ABC Scale is a 16-item self-assessment questionnaire that asks individuals to rate their confidence in maintaining balance during specific ambulatory activities on a numerical scale from 0 to 100. A score of 0 represents no confidence at all, while a score of 100 represents complete confidence in performing the activity. Each participant's total ABC score is calculated by summing the scores for each item and then dividing by the number of items. Botner et al. reported that the scale can be used to assess fear of falling in individuals with stroke. Myers and colleagues suggested that ABC scores below 50 indicate low physical function, scores between 50 and 80 indicate moderate physical function, and scores above 80 indicate high functionality among physically active older adults.
Functional Ambulation Category (FAC)
The FAC is a valid and reliable scale used in patients with post-stroke hemiparesis that classifies walking ability into six levels based on the amount of physical assistance required. A score of 0 indicates that the patient needs assistance from two people to walk, while a score of 5 represents independent walking on all surfaces including stairs.
Trunk Impairment Scale (TIS)
The scale was developed to assess trunk function after stroke. It consists of three sections: static sitting balance, dynamic sitting balance, and coordination. Due to a ceiling effect in the static sitting balance section, a revised version was developed in 2010 that excludes this section. This new version is recommended for patients with mild to moderate impairment and those in the chronic phase.
Other outcomes
Modified Ashworth Scale (MAS)
For the soleus muscle, the patient is positioned in a side-lying posture with the hips flexed at 45° and the knees flexed at 45°. For the gastrocnemius muscle, the patient remains in side-lying position with hips flexed at 45° and knees fully extended. The head and trunk are aligned in a straight line. The evaluator, positioned in front of the patient, stabilizes the lower leg proximally at the ankle joint with one hand, while the other hand is placed under the foot. The thumb is placed on the lateral surface of the calcaneus, fingers on the medial surface, and the palm supports the sole of the foot. The patient is instructed to relax as much as possible. The ankle is moved from maximum plantarflexion to maximum dorsiflexion. For the quadriceps femoris muscle, the patient lies in side-lying position with hips and knees fully extended. The evaluator stands behind the patient, stabilizes the thigh proximally near the knee on the lateral surface with one hand, and places the other hand
Montreal Cognitive Assessment (MoCA)
The MoCA is a valid screening test designed for the rapid assessment of mild cognitive impairment in individuals post-stroke. It is a one-page, 30-point test that evaluates various cognitive domains including visuospatial abilities, executive functions, short-term memory, attention, language, and orientation to time and place. Scores of 26 and above are generally considered normal, 18-25 indicate Mild Cognitive Impairment, 10-17 suggest Moderate Dementia, and scores below 10 indicate Severe Dementia. An adjustment of +1 point can be made for individuals with lower education levels (12 years or less of formal education).
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