Efficacy of Immersive Virtual Reality Combined With Stationary Cycling on Gait in Individuals With Stroke

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 Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Neurological Physiotherapy intervention (NP).; Device: Virtual Reality Combined with Stationary Cycling intervention (VR-SC)

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neurological Physiotherapy (Group A); 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.	Other: 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.; Device: 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).
Experimental: Virtual Reality Combined with Stationary Cycling (Group B); 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.	Other: 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.; Device: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	The outcome measures will include the Berg Balance Scale (BBS). Scores range from 0 to 56, with lower scores indicating greater balance impairment.	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.	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.	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).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived improvement	The outcome measures will include the Patient Global Impressions of Improvement (PGI-I). A single-item measure, from 0 to 7, in which participants rate their perceived change in condition following the intervention. Higher scores indicating perceived improvement because of the therapy.	The research team will assess participant perception after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).
User experience satisfaction in virtual reality	To assess satisfaction with VR as a therapeutic tool, both participants and clinicians will rate their satisfaction with the intervention program and technological devices on a 0-10 numeric scale, where 0 indicates very low satisfaction and 10 indicates complete satisfaction.	The research team will assess participant perception after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).

Collaborators and Investigators

• Sponsor: University of Cadiz

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: virtual reality; stationary cycling
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: SICEIA-2025-003245

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No