Impact of Robotic Glove Use on Quality of Life, Grip Strength and Fine Motor Control in ALS: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- ALS-Specific Quality of Life Questionnaire - Short Form
研究概览
简要总结
The goal of this clinical trial is to determine the impact of robotic glove use on quality of life, grip strength and fine motor control in participants with Amyotrophic Lateral Sclerosis (ALS). This will provide valuable insights into how an assistive technology intervention can influence functional ability in daily tasks and enhance overall well-being in individuals impacted by ALS.
Participants will attend 3 in-person clinic visits (BASE, 4 week and 8 week visit) and 2 Telehealth visits (occurring 24 hours after BASE and 4 week visit). The in-person clinic visits will include assessments by either a physical or occupational therapist, followed by assessments and scoring of grip strength, various fine motor strength assessments of affected hand, fine motor coordination assessment of the affected hand and various quality of life scales.
The participant will be fitted and measured for the appropriately sized robotic glove. Once the fit is confirmed, both the participant and caregiver will receive education on how to don and doff the glove, power it on and off, and follow the study protocol. Once they demonstrate understanding and independence with these steps, the intervention will begin.
The robotic glove intervention consists of either the participant or caregiver donning the glove and powering it on. A timer will be set for 20 minutes. The participant will sit comfortably at a table with their elbow supported on the table. The PI and/or member of the study team will be present throughout the 20 minute session to monitor for discomfort, fatigue or any additional patient reported symptoms. Once the time is complete, the robotic glove will be powered off and the glove removed. The participant and caregiver will be instructed to perform this one time daily, for 5 days per week for a total of 8 weeks. The PI and study team members will be available for any questions via iPhone or e-mail throughout this time period.
The Telehealth visits will consist of synchronous video and audio via the Zoom application. The PI and/or study team members will monitor the set up, application and powering on of the Robotic Glove. The treatment of 20 minutes will be monitored and any questions the participant or caregiver have will be answered. This visit's goal is to ensure compliance and proper application of the robotic glove.
详细描述
The primary aim of this study is to determine the impact of robotic glove use on quality of life, grip strength and fine motor control in participants with ALS. The study population includes 5 participants with a diagnosis of ALS, aged 18-99.
Once consent and enrollment is complete, the participant will be measured for their robotic glove size on day of enrollment. The robotic glove is a rehabilitation device that fits over the participants fingers and is secured through velcro straps. It delivers passive range of motion through an air pump that facilitates finger flexion and extension.
Measurements will be performed with a standard tape measure. The following 3 measurements will be taken of the participants affected hand:
- Hand width: determined by the base of the 1st metacarpal to distal end of 5th metacarpal
- Hand length: determined by lunate to distal end of distal phalanx of digit 3
- Middle finger circumference: determined by the circumference of the distal end of proximal phalanx of digit
The proper size robotic glove will be obtained and the BASE clinic visit will be scheduled.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of clinically possible, probable or definite amyotrophic lateral sclerosis by the treating neurologist
- •Have a caregiver that is willing and present to assist with application of robotic glove
- •Reports fine motor deficits or grip strength deficits in at least 1 hand
- •Demonstrates > or = 3 lbs. of Grip strength as measured by a dynamometer on affected hand AND/OR Demonstrates Fine motor deficits and has > or = 1 lb. of pinch strength (tip to tip, three jaw chuck, or lateral key pinch) as measured by pinch gauge dynamometer
- •Demonstrates a loss of at least 3 lbs. of Grip strength OR 1lb. of pinch strength over a minimum of 1 month period in affected hand
- •Stable dose of efficacious medications for 30 days.
排除标准
- •History of Rheumatoid Arthritis
- •History of Depuytren's contracture
- •Open wound at affected hand where robotic glove will be placed
- •History of Trigger Finger
- •Complete loss of sensation at the affected hand where robotic glove will be placed
- •History of Carpal Tunnel Syndrome
- •Prior or current use of robotic glove
- •Active physical or occupational therapy treatment interventions on affected hand
研究组 & 干预措施
Robotic Glove Intervention
Participants with initiate robotic glove use 5 days / week , 1x/day for 20 minutes
干预措施: Robotic Glove Use (Device)
结局指标
主要结局
ALS-Specific Quality of Life Questionnaire - Short Form
时间窗: Baseline, 4 weeks, 8 weeks
is a validated, disease-specific questionnaire designed to assess quality of life in individuals with ALS. It provides a concise measure of key domains such as emotional well-being, physical symptoms, social interaction, and existential concerns. The short-form version reduces patient burden while maintaining strong reliability and sensitivity to changes in health status over time.
次要结局
- EuroQOL-5D(Baseline, 4 weeks and 8 weeks)
- Grip Strength(Baseline, 4 weeks, 8 weeks)
- Finger tip to tip pinch strength(baseline, 4 weeks, 8 weeks)
- Palmar pinch strength(Baseline, 4 weeks and 8 weeks)
- Key Pinch Strength(Baseline, 4 weeks and 8 weeks)
- 9 Hole PEG test(Baseline, 4 weeks and 8 weeks)
- Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised (ALSFRS-R)(Baseline, 4 weeks and 8 weeks)
研究者
Kayla Chomko
Rehabilitation Director
Nova Southeastern University