Assessing the Feasibility of Behavioural Activation (BA) to Support People With Parkinson's Disease Enhanced by a Virtual Reality Exercise Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- GAD-7
研究概览
简要总结
The proposed research project will involve developing and testing the feasibility of a 6 week Behavioural Activation (BA) programme for people with Parkinson's Disease, which will be enhanced by Virtual Reality exercise programme. The aim of the programme will be to support the mental well-being and physical rehabilitation of people with Parkinson's Disease who are known to Marie Curie Outpatient Department (Belfast).
The main question[s] it aims to answer are:
Is a Behavioural Activation (BA) enhanced by a Virtual Reality exercise programme feasible and can it support the mental well-being and physical rehabilitation of People with Parkinson's Disease ?
Can the potential impacts of the intervention help to reduce anxiety and depression, as well as improve balance, social interaction and adherence to the programme?
Participants will:
- Attend a group for 6 weeks with the addition of an introductory session, for 1.5 hours per session.
- During sessions they will be asked to take part in a Behavioural Activation talking therapy. The aim of the intervention is to engage patients through activation strategies and help support adherence to exercise programmes. Participants will complete 'homework' tasks between sessions.
- In addition to this, the BA intervention will be enhanced by Virtual Reality exercises and participants will complete exercises within the immersive space using a VR headset.
- Data collection will capture any changes in depression, anxiety, balance,social interaction and adherence to the programme.
- The intervention will be carried out in three phases.
详细描述
The research design will be a small-scale feasibility study. The study will use a pre-test and post-test design to assess the feasibility of Behavioural Activation (BA) to support people with Parkinson's Disease enhanced by a Virtual Reality exercise programme.
Aims and objectives:
This research aims to address this gap in the evidence base by developing and testing the feasibility of a Behavioural Activation (BA) enhanced by a Virtual Reality exercise programme for supporting the mental well-being and physical rehabilitation of People with Parkinson's Disease.
- Developing and creating a Behavioural Activation intervention
- Determine recruitment and retention rates
- Test the feasibility of Behavioural Activation (BA) enhanced by Virtual Reality exercise for people with Parkinson' s Disease.
- Pilot technology and methodological procedures
- Explore the potential impacts of the intervention in reducing anxiety and depression, as well as improving balance, social interaction and adherence to the programme.
The study will be conducted under the supervision of the senior Physiotherapist, another physiotherapist and research nurse at the recruiting hospice site, alongside the researcher and other designated members of the clinical team. The intervention will take place in both the clinical setting at the hospice, as well as in the domiciliary setting. Quantitative data will be collected via pre and post-test outcome measures. Qualitative data will supplement findings to assess the acceptability of the intervention, frequency of use, as well as motivation, ease of use within the home setting, adaptation and adherence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a diagnosis of Idiopathic Parkinson's Disease which has been diagnosed by a neurologist.
- •Patients with an early to moderate disease stage Hoehn and Yahr scale 1-3
- •Patients with a BERG Balance Scale > 45
- •Currently not attending any other rehab programme/participation in another clinical trial
- •Able to exercise independently & mobilise
- •No hospitalisation or medication change within the past month
- •No other serious medical or surgical condition
- •Have direct contact with a participant on the BAPP-VR programme in the role of a carer.
- •Healthcare staff:
- •Have helped in some capacity to facilitate the intervention or referred patients to BAPP-VR
排除标准
- •Those who are unwilling/unable to provide written consent to participate
- •Not receiving another form of psychotherapy
- •Actively suicidal
- •No other Neurological Condition
- •Vision/ auditory impairment.
- •Carers and healthcare staff:
- •Those who are unwilling/unable to provide written consent to participate
研究组 & 干预措施
Behavioural Activation enhanced by Virtual Reality exercises
Participants will attend a 6 week BA group talking therapy (50mins-1hour) followed by a (30 min) exercise session enhanced with the use of Virtual Reality. Participants will be immersed in a virtual reality forest where they will complete a variety of physio chosen exercises. This intervention will be run in three phases.
干预措施: BAPP-VR (Other)
结局指标
主要结局
GAD-7
时间窗: From enrolment to the end of treatment - week 6
Anxiety Measure - lower score better outcome - out of possible score of 21
Berg Balance Scale
时间窗: From enrolment to the end of treatment - week 6
Balance test - higher score better outcome - out of possible score of 56
PHQ-9
时间窗: From enrolment to the end of treatment - week 6
Derpession measure - lower score better outcome -out of possible score of 27
次要结局
未报告次要终点
研究者
Dr Paul Best
Principal Investigator
Queen's University, Belfast