Disability EvaluationNCT07568821
Effectiveness of VR Rehabilitation for People With Asymmetrical Gait Patterns
A study testing Virtual Reality (VR) and Standard Rehabilitation and Standard Rehabilitation in people with Disability Evaluation and Recovery of Function, run by University of Rzeszow.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Disability Evaluation, Recovery of Function, Rehabilitation
- What is being tested?
- Virtual Reality (VR) and Standard Rehabilitation and Standard Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Disability Evaluation, Recovery of Function, Rehabilitation
- Being tested
- Virtual Reality (VR) and Standard Rehabilitation, Standard Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) and Standard RehabilitationOther
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.
Standard RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| VR Therapy and Standard Rehabilitation | Experimental | Not described Receives: Other: Virtual Reality (VR) and Standard Rehabilitation |
| Control: Standard Rehabilitation | Other | Not described Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed - 10-meter walk test
Measured: Baseline (Day 1)
Gait speed - 10-meter walk test
Measured: Immediately after therapy completion (Day 10)
Walking Endurance - 6-Minute Walk Test
Measured: Baseline (Day 1)
Walking Endurance - 6-Minute Walk Test
Measured: Immediately after therapy completion (Day 10)
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Measured: Baseline (Day 1)
Independent Mobility and Fall Risk - Timed "Get Up & Go" Test
Measured: Immediately after therapy completion (Day 10)
Lower Limb Loading Symmetry - Two-Scale Test
Measured: Baseline (Day 1)
Lower Limb Loading Symmetry - Two-Scale Test
Measured: Immediately after therapy completion (Day 10)
Secondary outcomes (4)
Gait and Balance - Dynamic Gait Index
Measured: Baseline (Day 1)
Gait and Balance - Dynamic Gait Index
Measured: Immediately after therapy completion (Day 10)
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.
Measured: Baseline (Day 1)
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.
Measured: Immediately after therapy completion (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Guzik, PhD, University of Rzeszow
- Investigators
- Agnieszka Guzik, Principal investigator, Rzeszów, Al. Rejtana 16C, Poland 35-310
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568821
- Sponsor's protocol ID
- 1/11/2025
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Rehabilitation in Patients With Gait Pattern Asymmetry Using a Virtual Reality
- ClinicalTrials.gov ID
- NCT07568821
- Acronym / sponsor ID
- 1/11/2025
- Conditions
- Disability Evaluation, Recovery of Function, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Therapy and Standard Rehabilitation | Experimental | Other: Virtual Reality (VR) and Standard Rehabilitation |
| Control: Standard Rehabilitation | Other | Other: Standard Rehabilitation |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality (VR) and Standard RehabilitationThe 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. | Other | VR Therapy and Standard Rehabilitation |
| Standard RehabilitationThe 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. | Other | Control: Standard Rehabilitation |
Primary outcome
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)
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agnieszka Guzik principal investigator
Rzeszów, Al. Rejtana 16C, Poland 35-310
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (VR) and Standard Rehabilitation and Standard Rehabilitation in people with Disability Evaluation and Recovery of Function, run by University of Rzeszow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnieszka Guzik (+48 17 851 8965, aguzik@ur.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed - 10-meter walk test (time frame: Baseline (Day 1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.