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

Not Applicable

Not yet recruiting

• Conditions: Stroke; COPD; Cerebral Palsy; Healthy Volunteer

• Registration Number: NCT07050654
• Lead Sponsor: Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-30
• Study First Posted: 2025-07-03
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-23
• Study Start: 2025-09-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Motivation	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).

Secondary Outcome Measures

Name	Time	Method
Endurance	At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).	Assisted 6-minute cycling test (A6MCT)
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.	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.
Physical activity inclination	At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).	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".
Attitude toward technology	At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).	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".
Usability	Day 1	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).
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.	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".
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.	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 \[# points collected by the two players if collaborative, equal to personal if competitive\].