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

NCT07529665 | Not Yet Recruiting

• 1 other identifier: SICEIA-2025-003245
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Stroke

Keywords

virtual reality; stationary cycling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Balance

  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 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 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 Outcomes (2)

• Perceived improvement

  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

  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).

Study Arms (2)

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.

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.

Other: Neurological Physiotherapy intervention (NP).; Device: Virtual Reality Combined with Stationary Cycling intervention (VR-SC)

Interventions

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.

Neurological Physiotherapy (Group A); Virtual Reality Combined with Stationary Cycling (Group B)

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).

Neurological Physiotherapy (Group A); Virtual Reality Combined with Stationary Cycling (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-01