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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 4
- 主要终点
- Motivation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Dual-task cycling (Device)
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.
干预措施: Dual-task cycling (Device)
结局指标
主要结局
Motivation
时间窗: 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).
次要结局
- Endurance(At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).)
- Physical activity inclination(At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).)
- Attitude toward technology(At the baseline; at the end of the 8th session (only for participants performing the 3 weeks of training).)
- 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.)
- Usability(Day 1)
- 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.)