Motivation While Doing Physical Exercise in a Social Dual-task Virtual Environment (ActivE3)

Istituto di Sistemi e Tecnologie Industriali Intelligenti per il Manifatturiero Avanzato

Status: Not yet enrolling

Conditions: Stroke; Cerebral Palsy; Healthy Volunteer; COPD

Treatments: Device: Dual-task cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT07050654

L2-245

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Multi-player mode: Social Bike

Experimental group

Description:

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.

Treatment:

Device: Dual-task cycling

Single-player mode

Active Comparator group

Description:

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.

Treatment:

Device: Dual-task cycling