Disability Evaluation, Recovery of Function, Rehabilitation
Conditions
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.
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
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.
OTHERStandard 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.
Sponsors
University of Rzeszow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait speed - 10-meter walk test | Baseline (Day 1) |
| Walking Endurance - 6-Minute Walk Test | Baseline (Day 1) |
| Independent Mobility and Fall Risk - Timed "Get Up & Go" Test | Baseline (Day 1) |
| Lower Limb Loading Symmetry - Two-Scale Test | Baseline (Day 1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Asymmetry - Wisconsin Gait Scale | 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. |
| Gait and Balance - Dynamic Gait Index | Baseline (Day 1) | — |
Contacts
CONTACTAgnieszka Guzik
PRINCIPAL_INVESTIGATORAgnieszka Guzik
Rzeszów, Al. Rejtana 16C, Poland 35-310
Outcome results
None listed