The Impact of 'Digital Strolling' on Depression and Quality of Life of People With Severe Mobility Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility: Time taken to recruit the sample
研究概览
简要总结
This intervention aims to develop and test the feasibility, acceptability, and preliminary effects of a "Digital Strolling" intervention among people with SMI. The intervention group will receive a "Digital Strolling" intervention, which consists of 20 minutes "Digital strolling" for 10 days, with lessons occurring once a day. The control group will receive passive observation of virtual walking videos only.
详细描述
This study is a two-arm, pilot randomized controlled trial, which will be used to evaluate and compare the effects of the "Digital strolling" intervention and the passive observing control group.
Twenty-four participants will be recruited from the Hong Kong Polytechnic University. Participants will be assigned to the "Digital Strolling" or control group. Participants in the "Digital Strolling" group will receive an arm swing virtual walking intervention, which consists of 20 minutes of virtual walking for 10 days and is conducted at home. Qualitative interviews with the "Digital Strolling" group will be conducted to understand their acceptability, usability, perceived strengths, and limitations of the intervention. While the one in the control group will receive 10 passive observing walking videos for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inability to walk 4 meters in less than 10 seconds without walking aids, or self-, proxy-, or medical-record-reported inability to walk independently across a small room (≈ 4 m), or dependence on a walking aid for more than 6 months
- •Minimum 6 months post-injury or disease onset
- •Able to communicate in Cantonese
排除标准
- •Have severe cognitive impairment (a score < 6 on the Abbreviated Mental Test)
- •Have severe mental illness (i.e., schizophrenia and major depression)
- •Have acute medical illness or exacerbation requiring hospital or intensive treatment; planned major surgery or inpatient rehabilitation during the study period
- •Currently engage in similar interventions
研究组 & 干预措施
Virtual walking group
Participants in the virtual walking group will use arm swing locomotion to experience virtual walking in 10 "Digital Strolling" scenarios, mainly in a variety of natural environments.
干预措施: Virtual walking (Behavioral)
Passive observing group
Participants in the passive observing group will look at 10 different walking videos.
干预措施: Passive observing walking (Behavioral)
结局指标
主要结局
Feasibility: Time taken to recruit the sample
时间窗: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
The total time taken to recruit the target sample size.
Feasibility: Recruitment rate
时间窗: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
The percentage of eligible participants who provide informed consent.
Feasibility: Drop-out rate
时间窗: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
The percentage of randomised participants who withdrew post-randomization
Acceptability: Adherence rate
时间窗: This outcome will be measured at the end of the 10-day intervention period.
Number of participants who completed the intervention modules as defined by the protocol.
Intervention satisfaction
时间窗: The outcome will be assessed 1 week post-intervention.
Participant satisfaction will be explored via semi-structured one-to-one interviews to identify barriers and facilitators.
Adverse event
时间窗: The outcome will be assessed through study completion, which is expected to be an average of 6 months.
Number of participants experiencing at least one adverse event
次要结局
- VR experience(The Igroup presence questionnaire will be assessed pre-test and 1 week post-intervention)
- Chronic pain(Chronic pain will be assessed at pre-intervention and 1 week post-intervention.)
- Depression(Depression will be measured at pre-intervention and 1 week post-intervention.)
- Chronic pain(Chronic pain will be measured at pre-intervention and 1 week post-intervention.)
- Sleep quality(Sleep quality will be assessed at pre-intervention and 1 week post-intervention.)
- Quality of life (The 5-level EuroQol of Life -5 dimensions)(Quality of life will be assessed at pre-intervention and 1 week post-intervention.)
- Self-efficacy for exercise(Self-efficacy for exercise scale will be assessed pre-test and 1 week post-intervention)