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NCT Number: NCT07529665

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

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

  2. 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).

    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.

  3. 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).

    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.

Other outcomes

  1. Perceived improvement

    Time frame: 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).

    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.

  2. User experience satisfaction in virtual reality

    Time frame: 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).

    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.

Sponsors and collaborators

Lead sponsor

University of Cadiz

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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