Motivation While Doing Physical Exercise in a Social Dual-task Virtual Environment (NCT07050654) | Clinical Trial Compass
CompletedNot Applicable
Motivation While Doing Physical Exercise in a Social Dual-task Virtual Environment
Italy86 participantsStarted 2025-09-01
Plain-language summary
The goal of this interventional study is to assess the difference in participants' motivation while performing a virtual reality-based dual-task exercise in a single-player vs. multi-player modality. The populations involved are the following: healthy young adults (14-18 ys.); children and adolescents (12-17 ys.) with motor disorders; older adults with neurological or respiratory conditions. The main questions it aims to answer are:
Is a "social" virtual environment better in promoting motivation to perform physical exercise? Is a "social" virtual environment better in promoting involvement, perceived social inclusion, and exercise performance?
Forty participants will test the single-player and the multi-player scenarios in a single-session and will rate their experiences with subjective questionnaires. A subgroup of participants (12) will use the multi-player system for 3 weeks/3 times a week.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* For IRCCS E. Medea: patients 12 years and older with neuromotor pathologies;
* For Villa Beretta: adults with neurological pathologies;
* For INRCA Casatenovo: patients with chronic respiratory diseases, clinical stability for at least 4 weeks;
* Healthy volunteers: healthy students aged 14-18 years.
Exclusion Criteria:
* Absence of appropriate cognitive abilities to interact with virtual reality software;
* Presence of severe sensory deficits (visual acuity, auditory perception) such as to interfere with the administration of the proposed activities;
* Poor trunk control or physical limitations (excessive spasticity or joint limitations) that impair the safe performance of the pedaling activity. Presence of epilepsy or treatment with antiepileptic drugs, where the physician highlights contraindications;
* Participation in other standardized rehabilitation protocols involving lower limbs and walking.
Specifically, for INRCA Casatenovo:
* clinical instability (pH \<7.35, hemodynamic instability, resting tachypnea);
* acute exacerbations in the month prior to enrollment;
* cognitive impairment such that participation in rehabilitation activities is impaired (Mini Mental State Examination \< 24);
* cardiovascular decompensation NYHA (New York Heart Association) class III and IV;
* major cardiac arrhythmias;
* active solid or hematologic neoplasms;
* recent myocardial infarction (\< 6 months);
* orthopedic clinical conditions that interfere with exercis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Motivation
Timeframe: Day 1 - at the end of the test with Condition 1 (single- or multi-player); Day 1 - at the end of the test with Condition 2 (multi- or single-player). At the end of the 4th and the 8th sessions for the participants performing 3 weeks of training.
Trial details
NCT IDNCT07050654
SponsorIstituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato