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Not yet recruiting NCT07568821

Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns

No phase Interventional Disability Evaluation Recovery of Function Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality (VR) and Standard Rehabilitation, Standard Rehabilitation.
Who it may be relevant to
Registry conditions: Disability Evaluation, Recovery of Function, Rehabilitation. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality

Overview

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.

Detailed description

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.

Interventions

  • Other Virtual Reality (VR) 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 a
  • Other Standard Rehabilitation
    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.

Primary outcome measures

  • Gait speed - 10-meter walk test [Time frame: Baseline (Day 1)]
  • Gait speed - 10-meter walk test [Time frame: Immediately after therapy completion (Day 10)]
  • Walking Endurance - 6-Minute Walk Test [Time frame: Baseline (Day 1)]
  • Walking Endurance - 6-Minute Walk Test [Time frame: Immediately after therapy completion (Day 10)]
  • Independent Mobility and Fall Risk - Timed "Get Up & Go" Test [Time frame: Baseline (Day 1)]
  • Independent Mobility and Fall Risk - Timed "Get Up & Go" Test [Time frame: Immediately after therapy completion (Day 10)]
  • Lower Limb Loading Symmetry - Two-Scale Test [Time frame: Baseline (Day 1)]
  • Lower Limb Loading Symmetry - Two-Scale Test [Time frame: Immediately after therapy completion (Day 10)]
Secondary outcome measures (4)
  • Gait and Balance - Dynamic Gait Index [Time frame: Baseline (Day 1)]
  • Gait and Balance - Dynamic Gait Index [Time frame: Immediately after therapy completion (Day 10)]
  • Gait Asymmetry - Wisconsin Gait Scale [Time frame: Baseline (Day 1)]
  • Gait Asymmetry - Wisconsin Gait Scale [Time frame: Immediately after therapy completion (Day 10)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07568821 · 1/11/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗