NCT07529665

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Cadiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-01-01
• Completion: 2027-06-01
• First posted: 2026-04-14
• Last updated: 2026-04-14