NCT07568821

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2027

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 28, 2026

Last Update Submit

April 28, 2026

Conditions

Outcome Measures

Primary Outcomes (8)

  • Gait speed - 10-meter walk test

    Baseline (Day 1)

  • Gait speed - 10-meter walk test

    Immediately after therapy completion (Day 10)

  • Walking Endurance - 6-Minute Walk Test

    Baseline (Day 1)

  • Walking Endurance - 6-Minute Walk Test

    Immediately after therapy completion (Day 10)

  • Independent Mobility and Fall Risk - Timed "Get Up & Go" Test

    Baseline (Day 1)

  • Independent Mobility and Fall Risk - Timed "Get Up & Go" Test

    Immediately after therapy completion (Day 10)

  • Lower Limb Loading Symmetry - Two-Scale Test

    Baseline (Day 1)

  • Lower Limb Loading Symmetry - Two-Scale Test

    Immediately after therapy completion (Day 10)

Secondary Outcomes (4)

  • Gait and Balance - Dynamic Gait Index

    Baseline (Day 1)

  • Gait and Balance - Dynamic Gait Index

    Immediately after therapy completion (Day 10)

  • Gait Asymmetry - Wisconsin Gait Scale

    Baseline (Day 1)

  • Gait Asymmetry - Wisconsin Gait Scale

    Immediately after therapy completion (Day 10)

Study Arms (2)

VR Therapy and Standard Rehabilitation

EXPERIMENTAL
Other: Virtual Reality (VR) and Standard Rehabilitation

Control: Standard Rehabilitation

OTHER
Other: Standard Rehabilitation

Interventions

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.

Control: 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.

VR Therapy and Standard Rehabilitation

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Agnieszka Guzik

    Rzeszów, Al. Rejtana 16C, Poland 35-310

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnieszka Guzik

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 6, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04