Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorUniversity of Rzeszow
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality (VR) and Standard Rehabilitation
Other interventionThe 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.
Standard Rehabilitation
Other interventionThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: VR Therapy and Standard RehabilitationExperimental treatment 1 intervention
Group B: Control: Standard RehabilitationOther 1 intervention
Trial outcomes
Primary outcomes
1
Gait speed - 10-meter walk test
Time frame
Baseline (Day 1)2
Gait speed - 10-meter walk test
Time frame
Immediately after therapy completion (Day 10)3
Walking Endurance - 6-Minute Walk Test
Time frame
Baseline (Day 1)4
Walking Endurance - 6-Minute Walk Test
Time frame
Immediately after therapy completion (Day 10)Secondary outcomes
1
Gait and Balance - Dynamic Gait Index
Time frame
Baseline (Day 1)2
Gait and Balance - Dynamic Gait Index
Time frame
Immediately after therapy completion (Day 10)3
Gait Asymmetry - Wisconsin Gait Scale
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.
Time frame
Baseline (Day 1)4
Gait Asymmetry - Wisconsin Gait Scale
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.
Time frame
Immediately after therapy completion (Day 10)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: