'Managing the Mental State' to Tackle Anxiety-related Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- % time frozen during a personalized gait trajectory
研究概览
简要总结
The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease.
详细描述
Rationale:
Freezing of Gait (FOG) is a common and disabling symptom in people with Parkinson's Disease (PD), characterized by paroxysmal episodes where there is an inability to step effectively, despite attempting to do so. Treatment consists of complementary pharmacological and non-pharmacological treatment options which unfortunately only partially alleviate FOG. Anxiety has been found to contribute to the occurrence and exacerbation of FOG, which often manifests itself in situations where people with FOG anticipate not being in control of their movements. People with FOG are often aware of the feelings and situations that elicit FOG episodes, but they rarely actively employ strategies targeting their mental state to improve FOG. With the exception of general interventions including mindfulness, yoga and meditation, tailored strategies to ameliorate anxiety-related FOG have never been evaluated in a systematic manner.
Objective:
In this project we aim to evaluate whether a non-pharmacological and tailored intervention targeting anxiety- and stress-related FOG in people with PD is effective to reduce the impact of anxiety and stress on FOG. Specifically, we aim to study: (1) the effect of four sessions of a 'managing the mental state' intervention in people with disabling and anxiety-related FOG; and (2) the key determinants of the effectiveness of the intervention to reduce the impact of anxiety and stress on FOG.
Study design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomization will be performed in CastorEDC, a web-based data management system for academic studies (www.castoredc.com). Breaking of the randomization code is not applicable, since researchers and trainers cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men/women of age > 18 years with idiopathic Parkinson's disease, as diagnosed by the UK Brain Bank Criteria;
- •Presence of daily FOG (as objectified with the new-freezing of gait questionnaire), that is related to anxiety (positive answer to the question: Does FOG occur -or get worse when you are anxious or stressed?);
- •Using a stable dose of PD medication and stability of DBS settings (if applicable) during the trial. Adjustments of PD medication and DBS settings during the trial are allowed if deemed clinically necessary.
- •Written informed consent.
排除标准
- •Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait.
- •Severe cognitive impairment hampering the ability to comply to the study protocol.
研究组 & 干预措施
Intervention
The intervention group will receive 4 sessions of the 'managing the mental state' intervention immediately after randomization.
干预措施: Psychological intervention (Other)
Waitlist
The control group will enter a waiting period of 4 weeks and receive the same 4-week intervention thereafter.
干预措施: Psychological intervention (Other)
结局指标
主要结局
% time frozen during a personalized gait trajectory
时间窗: Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
The primary outcome measure involves the percentage of time frozen during a personalized walking trajectory that includes self-selected FOG 'hotspots' in the home setting. This gait trajectory will be exactly the same during the baseline and consecutive measurements, and will be performed at comfortable gait speed. The gait trajectory will be video-taped by the assessor and performed three times during each visit.
次要结局
- Heart Rate Variability(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- Gait-Specific Attention Profile(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- New Freezing of Gait Questionnaire(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- The Parkinson Anxiety Scale (PAS)(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- he Updated Perceived Control over Falling Scale (UP-COF)(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- The Parkinson's Disease Questionnaire(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- The Rosenberg self-esteem score(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))
- Perceived Stress Scale(Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline))