Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns
Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality
A randomized comparative study will be conducted to evaluate the rehabilitation process using a VR-based application versus conventional therapy in 40 patients (sample size determined using a sample size calculator). After meeting the eligibility criteria, participants will be randomly assigned to two groups: the experimental group (20 patients with gait pattern asymmetry), performing a gait training program using a VR rehabilitation application, and the control group (20 patients with gait pattern asymmetry), performing only a conventional gait training program.
Participants in both groups will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours. Patient assessment will be conducted twice: an initial evaluation before the start of the intervention (Assessment I) and a follow-up evaluation after completion of the 2-week program (Assessment II), at the same time of day, under the same conditions, and using the same measurement tools.
Přehled studie
Postavení
Detailní popis
Individuals with a diagnosed and clinically confirmed asymmetry of gait pattern will be eligible for inclusion in the study.
Exclusion criteria: Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions affecting the safety and effectiveness of rehabilitation, Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea), Lower limb injuries or surgeries within the last 6 months, Severe mental disorders preventing understanding of instructions.
Training for both groups will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading. Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance. The effects of gait training will be evaluated using the following measures: gait speed, walking endurance, independent mobility and risk of falls, balance, gait symmetry, spinal mobility, and functional performance.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Agnieszka Guzik
- Telefonní číslo: +48 17 851 8965
- E-mail: aguzik@ur.edu.pl
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Diagnosed and clinically confirmed gait pattern asymmetry in the course of neurological diseases
- Informed consent to participate in the study and willingness to comply with rehabilitation recommendations
Exclusion Criteria:
- Active rheumatic diseases, cancer, advanced diabetes, cardiovascular diseases, and other conditions that may affect the safety and effectiveness of rehabilitation
- Contraindications to VR therapy (epilepsy, motion sickness, dizziness, nausea)
- Lower limb injuries or surgeries within the last 6 months
- Severe mental disorders preventing understanding of instructions
- Lack of informed consent to participate in the study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: Kontrola: Standardní rehabilitace
|
The control group will participate only in a conventional gait training program.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
|
|
Experimentální: VR Therapy and Standard Rehabilitation
|
The experimental group will participate in a gait training program using a VR rehabilitation application.
Participants will take part in a 2-week rehabilitation program (Monday to Friday), with daily training sessions lasting up to 2 hours.
Training will include balance and coordination exercises, proprioceptive stimulation, and exercises aimed at improving step length symmetry and lower limb loading.
Additionally, the experimental group will receive 15 to 30 minutes (adjusted to the patient's abilities) of training using a VR application in a virtual environment, providing real-time feedback on body position, step length, and balance.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Gait speed - 10-meter walk test
Časové okno: Baseline (Day 1)
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Baseline (Day 1)
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Gait speed - 10-meter walk test
Časové okno: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Walking Endurance - 6-Minute Walk Test
Časové okno: Baseline (Day 1)
|
Baseline (Day 1)
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Walking Endurance - 6-Minute Walk Test
Časové okno: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Časové okno: Baseline (Day 1)
|
Baseline (Day 1)
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Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Časové okno: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Lower Limb Loading Symmetry - Two-Scale Test
Časové okno: Baseline (Day 1)
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Baseline (Day 1)
|
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Lower Limb Loading Symmetry - Two-Scale Test
Časové okno: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Gait and Balance - Dynamic Gait Index
Časové okno: Baseline (Day 1)
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Baseline (Day 1)
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Gait and Balance - Dynamic Gait Index
Časové okno: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Gait Asymmetry - Wisconsin Gait Scale
Časové okno: Baseline (Day 1)
|
The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
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Baseline (Day 1)
|
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Gait Asymmetry - Wisconsin Gait Scale
Časové okno: Immediately after therapy completion (Day 10)
|
The Wisconsin Gait Scale is an observational tool used to assess gait quality.
Scores range from 13.35 to 42, with higher scores indicating worse gait performance.
|
Immediately after therapy completion (Day 10)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Agnieszka Guzik, Rzeszów, Al. Rejtana 16C, Poland 35-310
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 1/11/2025
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