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

NCT ID: NCT07050654

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-10-31

Brief 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.

Conditions

Healthy Volunteer; Stroke; COPD; Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Multi-player mode: Social Bike

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.

Group Type: EXPERIMENTAL

Dual-task cycling

Intervention Type: DEVICE

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).

Single-player mode

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.

Group Type: ACTIVE_COMPARATOR

Dual-task cycling

Intervention Type: DEVICE

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).

Interventions

Dual-task cycling

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).

Intervention Type: DEVICE

Eligibility Criteria

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 exercise.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: collaborator

Centro Riabilitativo Villa Beretta

UNKNOWN

Sponsor Role: collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role: collaborator

Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sara Arlati

Role: CONTACT

sara.arlati@cnr.it

+3903412350201

Other Identifiers

L2-245

Identifier Type: -

Identifier Source: org_study_id