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The purpose of this study is to evaluate whether an intervention based on immersive virtual reality combined with stationary cycling, in addition to neurological physiotherapy, improves gait in individuals with stroke. The study will also assess the effects of this intervention on balance, coordination, motor function, muscle tone, and participants' and therapists' satisfaction.
The main questions this study aims to answer are:
Researchers will compare a program that combines immersive virtual reality and stationary cycling with neurological physiotherapy to a neurological physiotherapy program alone.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurological Physiotherapy (Group A) | Active Comparator | The neurological physiotherapy group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided. |
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| Virtual Reality Combined with Stationary Cycling (Group B) | Experimental | Virtual Reality Combined with Stationary Cycling group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurological Physiotherapy intervention (NP). | Other | The Neurological Physiotherapy intervention (NP) will include 60-minute sessions structured into six therapeutic blocks: gait training; trunk control; balance, righting and stepping reactions; lower limb strengthening; stretching of the affected lower limb; and sensory stimulation of the affected foot. Each block will last approximately 5 to 15 minutes per session, depending on the individual needs of the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Gait Assessment | The outcome measures will include the Wisconsin Gait Scale (WGS) for qualitative gait assessment. The Wisconsin Gait Scale consists of 14 observable items that analyze gait components. Each item is scored from 1 (normal) to 3 (atypical), except for item 1 (scored from 1 to 5) and item 11 (scored from 1 to 4). Total scores range from 13.35 to 42, with higher scores indicating greater gait impairment. | The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline). |
| Quantitative Gait Assessment | The outcome measures will include the 6-Minute Walk Test (6MWT) for quantitative gait assessment. The 6-Minute Walk Test measures the total distance in meters that the participant can walk within six minutes. The test is performed on a 30-meter course marked by two cones, with a chair available for rest if needed. | The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Balance | The outcome measures will include the Berg Balance Scale (BBS). Scores range from 0 to 56, with lower scores indicating greater balance impairment. | The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline). |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived improvement | The outcome measures will include the Patient Global Impressions of Improvement (PGI-I). A single-item measure, from 0 to 7, in which participants rate their perceived change in condition following the intervention. Higher scores indicating perceived improvement because of the therapy. | The research team will assess participant perception after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline). |
Inclusion Criteria:
Exclusion Criteria:
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| Virtual Reality Combined with Stationary Cycling intervention (VR-SC) | Device | The Virtual Reality Combined with Stationary Cycling intervention (VR-SC) will include 15 to 30 minutes of immersive virtual reality using the HOLOFIT VR Fitness software combined with stationary cycling, in addition to 30 minutes of neurological physiotherapy intervention (NP). Due to the reduced time allocated to NP, each therapeutic block will last approximately 2 to 10 minutes per session, depending on the individual needs of the participant. The VR-SC intervention will be delivered in five phases with progressively increasing cycling intensity and will include three virtual reality game modes (Exploration, Cardiogoals, and Race). Exercise intensity will vary across phases based on heart rate (HR), measured using a pulse oximeter. Stationary cycling resistance will be adjusted to keep the participant's HR within a predefined percentage range of maximum heart rate (HRmax). |
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| Motor Function | The outcome measures will include the Fulg-Meyer Lower Extremity (FM). This scale includes five domains. In this study, the motor function and coordination/speed domains of the lower extremity will be evaluated. Scores range from 0 to 34 points for the selected domains, with lower scores indicating greater motor function and coordination impairment. | The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline). |
| Spasticity | The outcome measures will include the Modified Ashworth Scale (MAS). The Modified Ashworth Scale measures resistance to passive muscle stretching on a 0 to 4 scale, where 0 indicates no increase in muscle tone and 4 indicates higher spasticity in flexion or extension. Spasticity assessment will focus on the hip adductors, hamstrings and triceps surae of the lower limb, as well as the pectoralis major, biceps brachii, and finger flexors of the upper limb. | The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline). |
| User experience satisfaction in virtual reality | To assess satisfaction with VR as a therapeutic tool, both participants and clinicians will rate their satisfaction with the intervention program and technological devices on a 0-10 numeric scale, where 0 indicates very low satisfaction and 10 indicates complete satisfaction. | The research team will assess participant perception after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline). |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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