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

NCT07050654 | Completed

• 1 other identifier: L2-245
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 4

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

Stroke; Healthy Volunteer; COPD; Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  Day 1

• Involvement

  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

  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

  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

  At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).

Study Arms (2)

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.

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.

Device: Dual-task cycling

Interventions

Dual-task cycling 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).

Multi-player mode: Social Bike; Single-player mode

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato: lead
• IRCCS Eugenio Medea: collaborator
• Centro Riabilitativo Villa Beretta: collaborator
• Istituto Nazionale di Ricovero e Cura per Anziani: collaborator

Study Sites (4)

IRCCS E. Medea

Bosisio Parini, LC, Italy

Location

IRCCS INRCA Casatenovo

Casatenovo, LC, Italy

Location

Villa Beretta Rehabilitation Clinic - Valduce Hospital

Costa Masnaga, LC, Italy

Location

CNR-STIIMA - Lecco

Lecco, Lecco, 23900, Italy

Location

MeSH Terms

Conditions

Stroke; Pulmonary Disease, Chronic Obstructive; Cerebral Palsy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 3, 2025
• Study Start: September 1, 2025
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: February 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)