A Randomized, Placebo Controlled Trial of Botulinum Toxin for Paratonic Rigidity in People With Advanced Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Impact on care-giver burden
研究概览
简要总结
Aim of the study is to perform a pilot study to assess the impact of Botulinum toxin on muscle tone, and caregiver burden in individuals who are cognitively impaired and who are fully dependent.
The primary objective is to confirm proof of principle that paratonic rigidity and the consequences associated with it can be reduced with injection of Botulinum toxin injections resulting in reduced care-giver burden.
The secondary objectives are to determine optimal time points for evaluation of efficacy in this patient population and whether the time period is sufficient for washout of Botulinum toxin effect; determine most salient and sensitive outcome measures; identify obstacles in data gathering; and lastly, to determine feasibility of battery of assessments in this pilot study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe cognitive impairment (complete dependency in all activities of daily living (ADLs)
- •Diagnosis of Alzheimer's disease, vascular dementia,or frontotemporal dementia
- •Score> 3 on the paratonic assessment instrument, with paratonic rigidity in an arm(s) interfering in the provision of care
排除标准
- •Alternate etiologies for increased tone
- •Botulinum toxin 6 months preceding the study
研究组 & 干预措施
Saline
Saline injection up to 5 cc in arm with paratonia (one time injection)
干预措施: Saline (Drug)
Botulinum Toxin
Up to 300 U (5 cc) of Botulinum toxin diluted 2:1 (2 cc per 100 U of Botulinum toxin) (one time injection)
干预措施: Botulinum Toxin (Drug)
结局指标
主要结局
Impact on care-giver burden
时间窗: 6 weeks for primary outcome, 32 weeks for entire study
Impact on caregiver burden in providing upper extremity care. Measured by the Carer Burden Scale which includes four items (cleaning the palm, cutting the fingernails, dressing, cleaning under the armpit). Each item rated on five point Likert scale ("no difficulty" to "cannot do task").
次要结局
- Joint angle measurement(6 weeks for secondary outcome, 32 weeks for entire study)
- Pain(6 weeks for secondary outcome, 32 weeks for entire study)
- Global Assessment(6 weeks for secondary outcome, 32 weeks for entire study)
- Visual Analogue Scale(6 weeks for secondary outcome, 32 weeks for entire study)
研究者
Dr. Galit Kleiner-Fisman
Medical Director, Assistive Technology Clinic, Assistant Professor Department of Medicine, University of Toronto
Assistive Technology Clinic, Canada