- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07568821
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Agnieszka Guzik
- Numero di telefono: +48 17 851 8965
- Email: aguzik@ur.edu.pl
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Controllo: Riabilitazione Standard
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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.
|
|
Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Gait speed - 10-meter walk test
Lasso di tempo: Baseline (Day 1)
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Baseline (Day 1)
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Gait speed - 10-meter walk test
Lasso di tempo: 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
Lasso di tempo: Baseline (Day 1)
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Baseline (Day 1)
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Walking Endurance - 6-Minute Walk Test
Lasso di tempo: 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
Lasso di tempo: Baseline (Day 1)
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Baseline (Day 1)
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Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Lasso di tempo: 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
Lasso di tempo: Baseline (Day 1)
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Baseline (Day 1)
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Lower Limb Loading Symmetry - Two-Scale Test
Lasso di tempo: Immediately after therapy completion (Day 10)
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Immediately after therapy completion (Day 10)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Gait and Balance - Dynamic Gait Index
Lasso di tempo: Baseline (Day 1)
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Baseline (Day 1)
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Gait and Balance - Dynamic Gait Index
Lasso di tempo: 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
Lasso di tempo: Baseline (Day 1)
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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
Lasso di tempo: Immediately after therapy completion (Day 10)
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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)
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Agnieszka Guzik, Rzeszów, Al. Rejtana 16C, Poland 35-310
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 1/11/2025
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .