Healthy VolunteerActivE3NCT07050654

Motivation While Doing Physical Exercise in a Social Dual-task Virtual Environment

A study testing Dual-task cycling in people with Healthy Volunteer and Stroke, run by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer, Stroke, COPD
What is being tested?: Dual-task cycling
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 4 sitesItaly
Study dates: 1 Sep 2025to 18 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

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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 exercise.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites

IRCCS E. Medea
Bosisio Parini, LC
IRCCS INRCA Casatenovo
Casatenovo, LC
Villa Beretta Rehabilitation Clinic - Valduce Hospital
Costa Masnaga, LC
CNR-STIIMA - Lecco
Lecco, Lecco, 23900

Other trials in Italy

About this study

Official title: Studio Della Motivazione All'Esercizio Fisico in modalità Social Dual-task in Ambiente di realtà Virtuale Non Immersiva" Nell'Ambito Del Progetto ActivE3 - Everyone, Everywhere, Everyday "Rif. 2021-0612 - CUP C13C21000200005

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.

Conditions: Healthy Volunteer, Stroke, COPD, Cerebral Palsy
Being tested: Dual-task cycling
Medical subject headings: Stroke, Pulmonary Disease, Chronic Obstructive, Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dual-task cyclingDevice
Pairs of participants are formed, who will be the SocialBike players; these pairs consist of users from the same center. The two players are in the same room where two replicas of the SocialBike system are installed.
The participants can each view, on their own screen, the virtual scenario, either a park or a city environment. Movement within these VR environments is synchronized with the patient's actual pedaling speed, measured in revolutions per minute (RPM) from the cycle ergometer. Movement occurs along a predefined path. The participant's heart rate will always be monitored.
The therapist chooses the optimal ergometer workload, the type of exercise, and social/single-player mode. Each session (either single- or multi-player mode) lasts 10 minutes. The available exercise are: "Find the intruder" (go/no-go task); "Prepare your Meal" (spatial attention); "Watch the road" (working memory).

Study groups in NCT07050654
Study group	Role	What they receive
Multi-player mode: Social Bike	Experimental	The participants engage in cognitive exercises while cycling through two virtual scenarios: a park and an urban environment. Three cognitive tasks are available to perform while cycling. Each task has been designed to focus on one or more cognitive abilities and try to reproduce activities and situations of daily living as much as possible. Each exercise is performed in couple, collaborating or competing with another peer. Participants communicate with each other thanks to a voice chat. In the case of competitive gameplay, both participants are expected to perform the same task and respond to the same stimuli. Each participant can view their own score as well as the score of their opponent. In the case of collaborative gameplay, the system allows participants to view the same environment and engage in the same task. However, participants take turns playing for a fixed number of seconds, determined by the therapist. Receives: Device: Dual-task cycling
Single-player mode	Active comparator	The same dual-task exercises described for the social modality can be played also in a single-player mode. Participants perform the cognitive task autonomosly and increase only their personal score. Receives: Device: Dual-task cycling

What is being measured

The primary outcome is the main question the study is designed to answer.

Motivation
Situational Motivation Scale (SIMS; Guay et al. 2000). This questionnaire is composed of 16 items to be rated with a Likert scale going from 1 (corresponds not all) to 7 (corresponds exactly). Items are grouped in four different subscale (Intrinsic Motivation, Identified Regulation, External Regulation, Amotivation). Each subscale score can vary between 1 (minimum) and 7 (maximum).
Measured: 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.

Secondary outcomes (7)

Usability
System Usability Scale (Brooke, 1996) - The scale ranges from 0 to 100. Higher scores indicate better usability.
Ratings can be described as follows: "Excellent" (85-100); "Good" (70-84); "Average" (50-69); "Poor" (<50).
Measured: Day 1
Involvement
Game Experience Questionnaire (GEQ) (IJsselsteijn, et al., 2013)- GEQ is composed of several subscales: Competence, Sensory and Imaginative Immersion, Flow, Tension/Annoyance, Challenge, Negative Affect, Positive Affect.
Each subscale ranges from 0, which means "Not at all", and 4, which means "Extremely". Higher score corresponds stronger experience in that dimension.
Measured: 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.
Perceived social inclusion
ad-hoc question; the question will address how much participants feel included while performing the physical activity. The answer ranges from 0 "not at all" to 4 "completely included".
Measured: 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.
Game and physical performance
The system automatically stores a file containing each player game and physical data for the session. In particular, the file will contain the exercise information: scenario, duration, task performed, level of difficulty, game mode (collaborative/competitive). In terms of performance, the following outcomes will be collected: average speed [revolutions per minute], average heart rate [beats per minute], personal score in the cognitive task [# points collected], final score in [# points collected by the two players if collaborative, equal to personal if competitive].
Measured: Data are stored automatically by the system each time the application is launched. Outcomes data are collected during each session of SocialBike use, i.e., during the single-sessions and each session of the 3 weeks of training.
Endurance
Assisted 6-minute cycling test (A6MCT)
Measured: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).
Physical activity inclination
Ad-hoc question; the question will address how much participants are motivated in performing physical activity. The answer ranges from 0 "not at all" to 4 "extremely motivated".
Measured: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).
Attitude toward technology
Ad-hoc question; the question will address how much participants feel at ease while interacting with technology. The answer ranges from 0 "not at all" to 4 "extremely at ease".
Measured: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202518 Dec 2025

First posted3 Jul 2025
Study start1 Sep 2025
Primary completion18 Dec 2025
Study completion18 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07050654
Sponsor's protocol ID: L2-245
Acronym: ActivE3
Status last verified: Jun 2025
First submitted: 3 Jun 2025
Last updated: 9 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Studio Della Motivazione All'Esercizio Fisico in modalità Social Dual-task in Ambiente di realtà Virtuale Non Immersiva" Nell'Ambito Del Progetto ActivE3 - Everyone, Everywhere, Everyday "Rif. 2021-0612 - CUP C13C21000200005
ClinicalTrials.gov ID: NCT07050654
Acronym / sponsor ID: ActivE3 / L2-245
Conditions: Healthy Volunteer, Stroke, COPD, Cerebral Palsy
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero AvanzatoUniversity, hospital or other
Collaborators: IRCCS Eugenio Medea, Villa Beretta Rehabilitation Center, Istituto Nazionale di Ricovero e Cura per Anziani
Study start: 1 Sep 2025 (actual)
Primary completion: 18 Dec 2025 (actual)
Study completion: 18 Dec 2025 (actual)
First posted: 3 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Multi-player mode: Social Bike	Experimental	Device: Dual-task cyclingThe participants engage in cognitive exercises while cycling through two virtual scenarios: a park and an urban environment. Three cognitive tasks are available to perform while cycling. Each task has been designed to focus on one or more cognitive abilities and try to reproduce activities and situations of daily living as much as possible. Each exercise is performed in couple, collaborating or competing with another peer. Participants communicate with each other thanks to a voice chat. In the case of competitive gameplay, both participants are expected to perform the same task and respond to the same stimuli. Each participant can view their own score as well as the score of their opponent. In the case of collaborative gameplay, the system allows participants to view the same environment and engage in the same task. However, participants take turns playing for a fixed number of seconds, determined by the therapist.
Single-player mode	Active comparator	Device: Dual-task cyclingThe same dual-task exercises described for the social modality can be played also in a single-player mode. Participants perform the cognitive task autonomosly and increase only their personal score.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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.
clinical instability (pH <7.35, hemodynamic instability, resting tachypnea);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dual-task cyclingPairs of participants are formed, who will be the SocialBike players; these pairs consist of users from the same center. The two players are in the same room where two replicas of the SocialBike system are installed. The participants can each view, on their own screen, the virtual scenario, either a park or a city environment. Movement within these VR environments is synchronized with the patient's actual pedaling speed, measured in revolutions per minute (RPM) from the cycle ergometer. Movement occurs along a predefined path. The participant's heart rate will always be monitored. The therapist chooses the optimal ergometer workload, the type of exercise, and social/single-player mode. Each session (either single- or multi-player mode) lasts 10 minutes. The available exercise are: "Find the intruder" (go/no-go task); "Prepare your Meal" (spatial attention); "Watch the road" (working memory).	Device	Multi-player mode: Social Bike, Single-player mode

Primary outcome

Motivation
Time frame: 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.
Situational Motivation Scale (SIMS; Guay et al. 2000). This questionnaire is composed of 16 items to be rated with a Likert scale going from 1 (corresponds not all) to 7 (corresponds exactly). Items are grouped in four different subscale (Intrinsic Motivation, Identified Regulation, External Regulation, Amotivation). Each subscale score can vary between 1 (minimum) and 7 (maximum).

7 secondary outcomes

Usability
Time frame: Day 1
Involvement
Time frame: 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.
Perceived social inclusion
Time frame: 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.
Game and physical performance
Time frame: Data are stored automatically by the system each time the application is launched. Outcomes data are collected during each session of SocialBike use, i.e., during the single-sessions and each session of the 3 weeks of training.
Endurance
Time frame: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).
Physical activity inclination
Time frame: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).
Attitude toward technology
Time frame: At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dual-task cycling in people with Healthy Volunteer and Stroke, run by Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato at 4 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motivation (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07050654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.