Validating Normal Kinematic Motion in Residual Limb Musculature of Ewing Amputees
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait
研究概览
简要总结
The agonist-antagonist myoneural interface (AMI) construct, known as the Ewing amputation at the trans-tibial level, has been shown to create a bi-directional neural communication platform as a means of controlling and interpreting proprioceptive feedback from a prosthetic joint. In AMI constructs, agonist-antagonist muscles are mechanically coupled within the residual limb, and volitional contraction of an agonist passively stretches that muscle's antagonist. The natural neural responses from muscle spindles within both muscles are then interpreted by the central nervous system as sensations of joint position and speed, associated with movement of the prosthesis.
The aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation.
The investigators hypothesize that the affected limb of patients with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation patients will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees.
详细描述
The specific aim of this research protocol is to evaluate the electromyographic and kinematic patterns of participants who have undergone unilateral lower extremity Ewing Amputation in order to determine how similar their residual limb data is when compared to their intact limb data. A secondary aim of this research may include comparison of the Ewing participant cohort's biomechanical patterns to a similar cohort of participants who have undergone standard amputation.
The investigators hypothesize that the affected limb of participants with the Ewing procedure will demonstrate a pattern of electromyographic activation of their AMI constructs and kinematic data that recapitulates the pattern seen in their intact limb. The investigators secondarily hypothesize that the kinematic assessment of Ewing Amputation participants will demonstrate patterns that are significantly more physiologic than those witnessed in similar assessments of standard amputees.
This will be a cross-sectional study with only one visit. A convenience sample of 16 participants who have previously undergone a lower extremity Ewing amputation will be recruited for the proposed study. Participants may subsequently be matched with up to 16 control participants who have previously undergone standard amputation procedures.
Participants will be assessed in a single session in the Motion Analysis Lab (MAL) at Spaulding Rehabilitation Hospital (SRH). Each visit will consist of the procedures described below and is expected to last about two and a half (2.5) hours.
The investigators will collect demographic data for each participant to help with the study population characterization. Such data will include questions about past medical and surgical history, height, weight, and prosthetic and functional history. In addition to self-reported data from the participant, the investigators may review the electronic medical record of any Mass General Brigham (MGB) participant in order to confirm demographic information.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Unilateral lower extremity amputees
- •Greater than 12 months post-amputation procedure
- •Possession and use of a working prosthesis as determined by subject's ability to wear it for 8 hours daily
- •A stable, well-fitting socket as indicated by no prosthetic modifications within the prior 14 days and no plans to modify it within the following 30 days
- •Follow-up visit with their prosthetist within the past 3 months
- •The ability to walk independently without an assistive device
- •The ability to follow directions and communicate pain or discomfort
排除标准
- •Patients beyond the stated age restrictions will be excluded
- •Patients who have any underlying neurologic, orthopedic, or cardiopulmonary impairment that affects their gait as assessed by the study clinician.
- •Patients with any medical or functional limitations preventing them from ambulating safely and independently without an assistive device.
- •Patients will be excluded who do not have a prosthesis
结局指标
主要结局
Symmetry of duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait
时间窗: Baseline
This is estimated by calculating the difference between the duration of co-contraction for the residuum and for the contralateral limb.
Duration of co-contraction of the ankle dorsi/plantar-flexor muscles during gait
时间窗: Baseline
The percentage of the gait cycle during which both the Tibialis Anterior and the Gastrocnemius muscles are active is estimated for the residuum and the contralateral side.
次要结局
- Symmetry of peak knee flexion during stance(Baseline)
- Symmetry of ankle power generation(Baseline)
研究者
Matthew Carty
Director, Lower Extremity Transplant Program, Brigham and Women's Hospital
Brigham and Women's Hospital