StrokeNCT07529665
Efficacy of Immersive Virtual Reality Combined With Stationary Cycling on Gait in Individuals With Stroke
A study testing Neurological Physiotherapy intervention (NP). and Virtual Reality Combined with Stationary Cycling intervention (VR-SC) in people with Stroke, run by University of Cadiz.
Trial summary
The purpose of this study is to evaluate whether an intervention based on immersive virtual reality combined with stationary cycling, in addition to neurological physiotherapy, improves gait in individuals with stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Neurological Physiotherapy intervention (NP). and Virtual Reality Combined with Stationary Cycling intervention (VR-SC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or older with a medically documented diagnosis of hemorrhagic or ischemic stroke.
- At least 6 months post-stroke.
- Presence of hemiparesis.
- Mild to moderate balance impairment, defined as a Berg Balance Scale score < 50.
- Gait impairment, defined as a Wisconsin Gait Scale score > 20.
- Preserved active movement in the lower limbs and ability to mount and remain seated on the stationary bicycle.
Who cannot join
- Severe cardiac conditions.
- Visual or auditory impairments limiting the use of virtual reality head-mounted displays.
- Medical history of epilepsy.
- Severe attentional impairment or inability to cooperate with the study intervention.
- Severe cognitive impairment and marked difficulties in comprehension.
- Severe vestibular disorders and predisposition to dizziness or vomiting.
About this study
The purpose of this study is to evaluate whether an intervention based on immersive virtual reality combined with stationary cycling, in addition to neurological physiotherapy, improves gait in individuals with stroke. The study will also assess the effects of this intervention on balance, coordination, motor function, muscle tone, and participants' and therapists' satisfaction.
The main questions this study aims to answer are:
Read more
- Does immersive virtual reality combined with stationary cycling improve gait compared with neurological physiotherapy alone?
- Does this combined intervention improve balance, coordination, motor function, and muscle tone in individuals with stroke?
- How do participants and therapists perceive the use of immersive virtual reality combined with stationary cycling during rehabilitation?
Researchers will compare a program that combines immersive virtual reality and stationary cycling with neurological physiotherapy to a neurological physiotherapy program alone.
Participants will:
- Take part in two intervention periods, with a total of 16 sessions over 8 weeks (two sessions per week).
- Receive intervention sessions that include immersive virtual reality combined with stationary cycling and neurological physiotherapy, or neurological physiotherapy alone, depending on the intervention period.
- Complete assessments of gait, balance, and motor function at baseline, after the first intervention period, and after the second intervention period.
- Conditions
- Stroke
- Being tested
- Neurological Physiotherapy intervention (NP)., Virtual Reality Combined with Stationary Cycling intervention (VR-SC)
- Keywords
- virtual reality, stationary cycling
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurological Physiotherapy intervention (NP).Other
The Neurological Physiotherapy intervention (NP) will include 60-minute sessions structured into six therapeutic blocks: gait training; trunk control; balance, righting and stepping reactions; lower limb strengthening; stretching of the affected lower limb; and sensory stimulation of the affected foot. Each block will last approximately 5 to 15 minutes per session, depending on the individual needs of the participant.
Virtual Reality Combined with Stationary Cycling intervention (VR-SC)Device
The Virtual Reality Combined with Stationary Cycling intervention (VR-SC) will include 15 to 30 minutes of immersive virtual reality using the HOLOFIT VR Fitness software combined with stationary cycling, in addition to 30 minutes of neurological physiotherapy intervention (NP). Due to the reduced time allocated to NP, each therapeutic block will last approximately 2 to 10 minutes per session, depending on the individual needs of the participant.
The VR-SC intervention will be delivered in five phases with progressively increasing cycling intensity and will include three virtual reality game modes (Exploration, Cardiogoals, and Race). Exercise intensity will vary across phases based on heart rate (HR), measured using a pulse oximeter. Stationary cycling resistance will be adjusted to keep the participant's HR within a predefined percentage range of maximum heart rate (HRmax).
| Study group | Role | What they receive |
|---|---|---|
| Neurological Physiotherapy (Group A) | Active comparator | The neurological physiotherapy group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided. Receives: Other: Neurological Physiotherapy intervention (NP).; Device: Virtual Reality Combined with Stationary Cycling intervention (VR-SC) |
| Virtual Reality Combined with Stationary Cycling (Group B) | Experimental | Virtual Reality Combined with Stationary Cycling group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided. Receives: Other: Neurological Physiotherapy intervention (NP).; Device: Virtual Reality Combined with Stationary Cycling intervention (VR-SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Gait Assessment
The outcome measures will include the Wisconsin Gait Scale (WGS) for qualitative gait assessment. The Wisconsin Gait Scale consists of 14 observable items that analyze gait components. Each item is scored from 1 (normal) to 3 (atypical), except for item 1 (scored from 1 to 5) and item 11 (scored from 1 to 4). Total scores range from 13.35 to 42, with higher scores indicating greater gait impairment.
Measured: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
Quantitative Gait Assessment
The outcome measures will include the 6-Minute Walk Test (6MWT) for quantitative gait assessment. The 6-Minute Walk Test measures the total distance in meters that the participant can walk within six minutes. The test is performed on a 30-meter course marked by two cones, with a chair available for rest if needed.
Measured: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
Secondary outcomes (3)
Balance
The outcome measures will include the Berg Balance Scale (BBS). Scores range from 0 to 56, with lower scores indicating greater balance impairment.
Measured: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
Motor Function
The outcome measures will include the Fulg-Meyer Lower Extremity (FM). This scale includes five domains. In this study, the motor function and coordination/speed domains of the lower extremity will be evaluated. Scores range from 0 to 34 points for the selected domains, with lower scores indicating greater motor function and coordination impairment.
Measured: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
Spasticity
The outcome measures will include the Modified Ashworth Scale (MAS). The Modified Ashworth Scale measures resistance to passive muscle stretching on a 0 to 4 scale, where 0 indicates no increase in muscle tone and 4 indicates higher spasticity in flexion or extension. Spasticity assessment will focus on the hip adductors, hamstrings and triceps surae of the lower limb, as well as the pectoralis major, biceps brachii, and finger flexors of the upper limb.
Measured: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529665
- Sponsor's protocol ID
- SICEIA-2025-003245
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2026
- Last updated
- 14 Apr 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Immersive Virtual Reality Combined With Stationary Cycling on Gait in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT07529665
- Acronym / sponsor ID
- SICEIA-2025-003245
- Conditions
- Stroke
- Keywords
- virtual reality, stationary cycling
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Apr 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.
The purpose of this study is to evaluate whether an intervention based on immersive virtual reality combined with stationary cycling, in addition to neurological physiotherapy, improves gait in individuals with stroke. The study will also assess the effects of this intervention on balance, coordination, motor function, muscle tone, and participants' and therapists' satisfaction.
The main questions this study aims to answer are:
- Does immersive virtual reality combined with stationary cycling improve gait compared with neurological physiotherapy alone?
- Does this combined intervention improve balance, coordination, motor function, and muscle tone in individuals with stroke?
- How do participants and therapists perceive the use of immersive virtual reality combined with stationary cycling during rehabilitation?
Researchers will compare a program that combines immersive virtual reality and stationary cycling with neurological physiotherapy to a neurological physiotherapy program alone.
Participants will:
- Take part in two intervention periods, with a total of 16 sessions over 8 weeks (two sessions per week).
- Receive intervention sessions that include immersive virtual reality combined with stationary cycling and neurological physiotherapy, or neurological physiotherapy alone, depending on the intervention period.
- Complete assessments of gait, balance, and motor function at baseline, after the first intervention period, and after the second intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurological Physiotherapy (Group A) | Active comparator | Other: Neurological Physiotherapy intervention (NP)., Device: Virtual Reality Combined with Stationary Cycling intervention (VR-SC)The neurological physiotherapy group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided. |
| Virtual Reality Combined with Stationary Cycling (Group B) | Experimental | Other: Neurological Physiotherapy intervention (NP)., Device: Virtual Reality Combined with Stationary Cycling intervention (VR-SC)Virtual Reality Combined with Stationary Cycling group will receive in 16 therapy sessions over 8 weeks, with two sessions per week. The study includes two treatment periods, each lasting 4 weeks and including 8 sessions. There will be a 4-week break between the two treatment periods, during which no study treatment will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 years or older with a medically documented diagnosis of hemorrhagic or ischemic stroke.
- At least 6 months post-stroke.
- Presence of hemiparesis.
- Mild to moderate balance impairment, defined as a Berg Balance Scale score < 50.
- Gait impairment, defined as a Wisconsin Gait Scale score > 20.
Key exclusion criteria (6 listed)
- Severe cardiac conditions.
- Visual or auditory impairments limiting the use of virtual reality head-mounted displays.
- Medical history of epilepsy.
- Severe attentional impairment or inability to cooperate with the study intervention.
- Severe cognitive impairment and marked difficulties in comprehension.
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 |
|---|---|---|
| Neurological Physiotherapy intervention (NP).The Neurological Physiotherapy intervention (NP) will include 60-minute sessions structured into six therapeutic blocks: gait training; trunk control; balance, righting and stepping reactions; lower limb strengthening; stretching of the affected lower limb; and sensory stimulation of the affected foot. Each block will last approximately 5 to 15 minutes per session, depending on the individual needs of the participant. | Other | Neurological Physiotherapy (Group A), Virtual Reality Combined with Stationary Cycling (Group B) |
| Virtual Reality Combined with Stationary Cycling intervention (VR-SC)The Virtual Reality Combined with Stationary Cycling intervention (VR-SC) will include 15 to 30 minutes of immersive virtual reality using the HOLOFIT VR Fitness software combined with stationary cycling, in addition to 30 minutes of neurological physiotherapy intervention (NP). Due to the reduced time allocated to NP, each therapeutic block will last approximately 2 to 10 minutes per session, depending on the individual needs of the participant. The VR-SC intervention will be delivered in five phases with progressively increasing cycling intensity and will include three virtual reality game modes (Exploration, Cardiogoals, and Race). Exercise intensity will vary across phases based on heart rate (HR), measured using a pulse oximeter. Stationary cycling resistance will be adjusted to keep the participant's HR within a predefined percentage range of maximum heart rate (HRmax). | Device | Neurological Physiotherapy (Group A), Virtual Reality Combined with Stationary Cycling (Group B) |
Primary outcome
Qualitative Gait Assessment
Time frame: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
The outcome measures will include the Wisconsin Gait Scale (WGS) for qualitative gait assessment. The Wisconsin Gait Scale consists of 14 observable items that analyze gait components. Each item is scored from 1 (normal) to 3 (atypical), except for item 1 (scored from 1 to 5) and item 11 (scored from 1 to 4). Total scores range from 13.35 to 42, with higher scores indicating greater gait impairment.
Quantitative Gait Assessment
Time frame: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
The outcome measures will include the 6-Minute Walk Test (6MWT) for quantitative gait assessment. The 6-Minute Walk Test measures the total distance in meters that the participant can walk within six minutes. The test is performed on a 30-meter course marked by two cones, with a chair available for rest if needed.
3 secondary outcomes
Balance
Time frame: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
Motor Function
Time frame: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
Spasticity
Time frame: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
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 14 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neurological Physiotherapy intervention (NP). and Virtual Reality Combined with Stationary Cycling intervention (VR-SC) in people with Stroke, run by University of Cadiz.
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 6 inclusion and 6 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 14 Apr 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative Gait Assessment (time frame: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).). The study lists 2 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 14 Apr 2026.