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Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns

5. mai 2026 oppdatert av: Agnieszka Guzik, PhD, University of Rzeszow

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Kontroll: Standard rehabilitering
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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Gait speed - 10-meter walk test
Tidsramme: Baseline (Day 1)
Baseline (Day 1)
Gait speed - 10-meter walk test
Tidsramme: Immediately after therapy completion (Day 10)
Immediately after therapy completion (Day 10)
Walking Endurance - 6-Minute Walk Test
Tidsramme: Baseline (Day 1)
Baseline (Day 1)
Walking Endurance - 6-Minute Walk Test
Tidsramme: Immediately after therapy completion (Day 10)
Immediately after therapy completion (Day 10)
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Tidsramme: Baseline (Day 1)
Baseline (Day 1)
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Tidsramme: Immediately after therapy completion (Day 10)
Immediately after therapy completion (Day 10)
Lower Limb Loading Symmetry - Two-Scale Test
Tidsramme: Baseline (Day 1)
Baseline (Day 1)
Lower Limb Loading Symmetry - Two-Scale Test
Tidsramme: Immediately after therapy completion (Day 10)
Immediately after therapy completion (Day 10)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gait and Balance - Dynamic Gait Index
Tidsramme: Baseline (Day 1)
Baseline (Day 1)
Gait and Balance - Dynamic Gait Index
Tidsramme: Immediately after therapy completion (Day 10)
Immediately after therapy completion (Day 10)
Gait Asymmetry - Wisconsin Gait Scale
Tidsramme: 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.
Baseline (Day 1)
Gait Asymmetry - Wisconsin Gait Scale
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Agnieszka Guzik, Rzeszów, Al. Rejtana 16C, Poland 35-310

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. august 2027

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

28. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 1/11/2025

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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