Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns

5. maj 2026 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Kontrol: Standardrehabilitering
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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. marts 2027

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 1/11/2025

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner