A Pilot Study of Shockwave Therapy for Lower Extremity Spasticity in Persons With Genetically-Confirmed HSP
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
研究概览
简要总结
This is a pilot study of the efficacy, safety, and tolerability of shockwave therapy for the treatment of spasticity in Hereditary Spastic Paraplegia.
详细描述
This is a pilot study investigating the efficacy, safety, and tolerability of Extracorporeal Shockwave Therapy (ESWT) for the treatment of lower-extremity spasticity in the setting of Hereditary Spastic Paraplegia (HSP). 8 participants will be treated with shockwave therapy targeting sites of maximal spasticity in the lower extremities for 3 sessions at a rate of once per week. Participants will fill out baseline questionnaires assessing their overall wellbeing and function prior to treatment session 1, and will complete follow-up questionnaires at visit 2, visit 3, a phone call within 7 days of visit 3, and 8 weeks after initial visit. Total time enrolled in the study will be 8 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Over the age of 18
- •Diagnosis of genetically-confirmed HSP
- •Score of 2, 3 or 4 on the PLSFRS walking question
- •30 days stable dosages of oral spasticity medications prior to screening and throughout study participation
- •Able to come to site for treatment sessions
- •Able to understand all study procedures
排除标准
- •Diagnosis of any other neurological disorder that may impact gait
- •Lower motor neuron (LMN) disease or combined UMN and LMN
- •Non-ambulatory or requiring two-person assistance for any functional ambulation on most days
- •Less than 3 months of symptoms
- •Have received SWT within the past 3 months
- •Prior botulinum toxin injection within 3 months or planning to receive botulinum toxin injections during the study participation for spasticity management
- •Presence of an intra-thecal baclofen pump
- •Women who are pregnant. This is due to the fact that pregnancy will reduce participants activity after the treatment and the safety concerns related to shockwave treatment.
- •Patients with neuropathy affecting sensation to pain
- •Patients with a known underlying cardiac disease that could be affected by shockwave therapy
- •Concomitant intake of another clinical trial or other off-label experimental treatments that might influence study outcomes
- •Presence of unstable psychiatric disease, cognitive impairments, or dementia impairing study participation
- •Presence of other chronic neurological diseases such as Alzheimer's Parkinson's, stroke, or multiple sclerosis
- •Personal history of narcotic overuse for chronic pain or substance abuse or dependence
- •Contraindications for ESWT, including local skin breakdown, infection, malignancy or other soft tissue pathology at sites of planned treatment.
结局指标
主要结局
Primary Lateral Sclerosis Functional Rating Scale (PLSFRS)
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of the rating scale ranges from 0-68, where 68 is a person who is completely asymptomatic.
Numerical Rating Scale for Pain
时间窗: 0-8 weeks; assessed at baseline visit, 1, 2, 3, and 8 weeks
A rating of pain from 0 (none) to 10 (worst)
Neurological Quality of Life (Neuro-QoL) Questionnaire: Fatigue Short Form
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 8 (least fatigue) to 40 (most fatigue)
Foot and Ankle Ability Measure (FAAM) Questionnaire: Activities of Daily Living Subscale
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 0 (maximally symptomatic in activities of daily living) to 84 (asymptomatic in activities of daily living).
Global Rate of Change (GROC) Questionnaire
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score ranges from -7 (maximally negative change) to +7 (maximally positive change)
Neurological Quality of Life (Neuro-QoL) Questionnaire: Satisfaction with Social Roles and Activities Short Form
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 8 (minimal satisfaction) to 40 (maximal satisfaction)
Foot and Ankle Ability Measure (FAAM) Questionnaire: Sports Subscale
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 0 (maximally symptomatic in sports activities) to 32 (asymptomatic in sports activities)
Ten-Meter Walk Test
时间窗: 0-3 weeks; assessed at baseline visit, 1, 2, and 3 weeks
Participants will be asked to walk ten meters 2x at their self-selected walking speed and 2x at their fast walking speed. Time taken to complete walks will be measured.
Neurological Quality of Life (Neuro-QoL) Questionnaire: Positive Affect and Wellbeing Short Form
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 9 (minimal wellbeing) to 45 (maximal wellbeing)
Neurological Quality of Life (Neuro-QoL) Questionnaire: Lower Extremity Function - Mobility Short Form
时间窗: 0-8 weeks; assessed at baseline visit, 1, 3, and 8 weeks
The score of this questionnaire ranges from 8 (minimal lower extremity function) to 40 (maximal lower extremity function)
次要结局
未报告次要终点
研究者
Adam Tenforde
Physician
Spaulding Rehabilitation Hospital