Training Independent Muscle Activation From a Common Source
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Co-Contraction Interference Measure
研究概览
简要总结
In this study, the investigators are evaluating a new surgical technique that may allow participants to control their muscles in a new way after their amputation or revision surgery. The investigators are looking for people who have limb amputation or require a revision operation to a previous amputation. Participants must be over 18 and younger than 65, willing to begin participation within two weeks of their surgery, and be willing to travel regularly to Boston.
In this study, participants will have a modified revision procedure on their amputated limb or a modified amputation procedure, followed by a series of follow up visits in clinic and to a gait lab at Harvard. Participants will also use a wearable device on their limb at home to complete daily training tasks and games.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65
- •Fluent in English
- •Approved for and scheduled to undergo acute amputation or revision amputation surgery (e.g. above-knee amputation with sciatic nerve ablation) OR sciatic nerve ablation for clinical indications (e.g. persistent pain, symptomatic neuroma, soft tissue breakdown, muscle atrophy, socket-related discomfort).
- •Willing and able to initiate participation within 14 days of surgery
- •Willing to perform at home studies
- •Possess adequate cognitive and communication abilities to describe their sensorimotor recovery during follow-up assessments
- •Demonstrate appropriate motivation and reliability to comply with scheduled training and evaluation sessions throughout the postoperative period
- •Able to travel to BWH/BWFH and Harvard University for all required visits without lodging support
排除标准
- •• Passive or active metal implants incompatible with EMG
- •Pacemakers, deep brain stimulators, or other electronic implantables
- •Pregnancy or breastfeeding
- •Current seizure disorder or other neurologically limiting conditions
- •Cognitive or developmental disorders that limit task comprehension
- •Vascular disorders impeding regeneration
- •Known impairments in wound healing, including connective tissue disorders or under chronic systemic corticosteroid therapy
- •Extensive peripheral neuropathies that may hinder neural regeneration and functional RPNI development
- •Active smoker
- •Are unable to provide informed consent
- •Have a demonstrated history of poor protocol adherence
- •Pregnant at the time of screening
研究组 & 干预措施
Surgical Intervention - RPNI Construction
Subjects undergoing the proposed operative intervention with associated follow up testing
干预措施: amputation or revision procedure with additional RPNI construction (Procedure)
结局指标
主要结局
Co-Contraction Interference Measure
时间窗: from operative intervention to 12 months postop
Degree of co-contraction interference or crosstalk between RPNIs, modeled by fitting an exponential decay fit to task error over time or repetitions
次要结局
- Task Performance Measure - Success Rate(from operative intervention to 12 months postop)
- Task Performance Measure - Speed(immediately post intervention to 12 months postop)
- Task Performance Measure - Participant Controllability(immediately post intervention to 12 months postop)
研究者
Matthew Carty
Roberta and Stephen R. Weiner Endowed Chair in Surgery, Brigham & Women's Hospital; Director, MGB Limb Restoration Research Initiative
Brigham and Women's Hospital