Tracking Neural Synergies During Gait Rehabilitation After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Neural Synergies
研究概览
简要总结
The purpose of this study is to identify neural muscle synergies of patients post-stroke and track them during an inpatient acute rehabilitation. To this end, the researchers will use an innovative approach based on the identification of large populations of motor units from recordings of surface high-density electromyography (HD-EMG).
详细描述
The researchers will focus on the identification of neural muscle synergies of leg and thigh muscles during postural and locomotor tasks in patients post stroke. To this end, the researchers will recruit 20 patients participating in inpatient rehabilitation at Shirley Ryan AbilityLab in the early subacute phase after stroke and 20 age-matched healthy controls. The researchers will ask them to perform postural tasks and walking trials at their preferential speed. All assessments will be performed by a licensed physiotherapist as per the standard of care once a week during three weeks of inpatient rehabilitation at the Shirley Ryan AbilityLab. During these tasks, the researchers will record HD-EMG signals from four muscle groups (Quadriceps, Hamstrings, Triceps Surae, Tibialis anterior).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants:
- •Inclusion Criteria:
- •Age 18-85 years old
- •Ambulatory with or without an assistive device
- •Ability to stand unassisted for at least 15 min
- •Informed consent provided by participant
- •English speaking
排除标准
- •Inability to communicate with researchers
- •Lower extremity joint pain, contractures
- •Major sensory deficits, or cardiovascular or respiratory symptoms contraindicative of walking
- •History or evidence of orthopedic, muscular, or physical disability
- •Taking current medications that may affect balance
- •History or evidence of vestibular, auditory, or proprioceptive impairment
- •History or indication of orthostatic hypotension
- •History of any neurological disease
- •Open wounds on surfaces in contact with HD-EMG electrodes
- •Concurrent participation in other lower limb research studies that according to the PI is likely to affect study outcome or confound results
- •Pregnancy
- •Inclusion Criteria:
- •Age 18-85 years old
- •Unilateral, supratentorial ischemic or hemorrhagic stroke within the past six months
- •Medical clearance from primary medical team (signed Medical Clearance form)
- •Unassisted sitting balance at edge of mat or hospital bed ≥ 30 seconds
- •Baseline Visible muscle contraction in hip flexors, knee extensors, and ankle dorsiflexors ( ≥1 MMT) or manual resistance against one muscle group (>3 MMT)
- •Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
- •Informed consent provided by participant or POA
- •English speaking
- •Exclusion Criteria:
- •Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
- •Severe behavioral neglect
- •History of prior stroke
- •Concurrent neurologic condition (i.e PD, TBI, MS, etc.)
- •History of peripheral nerve injury
- •Joint contracture or significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
- •Severe knee, hip, or ankle osteoarthritis
- •Severe osteoporosis as indicated by physician medical clearance
- •Open wounds on surfaces in contact with HD-EMG electrodes
- •Unstable spine or unhealed fractures
- •Weight bearing precautions
- •Unresolved deep vein thrombosis (DVT)
- •Concurrent participation in other lower limb research studies that according to the PI is likely to affect study outcome or confound results
- •Pregnancy
研究组 & 干预措施
Healthy Age-matched controls
Healthy individuals ages 18-85
Inpatients poststroke
Individuals post acute or subacute that that are inpatients at the Shirley Ryan AbilityLab ages 18-85
结局指标
主要结局
Change in Neural Synergies
时间窗: Baseline and Once weekly, through completion of study up to 4 weeks
The neural synergies are group of muscles that receive a common input from the brain. The researchers will assess the common input as the level of correlated activity between muscles. The researchers will compare this level of correlated activity between legs and groups, and how this changes over the course of the study
次要结局
- Step count(Each session, through completion of study up to 4 weeks)
- Change in stance time(Baseline and Once weekly, through completion of study up to 4 weeks)
- 10 Meter Walk Test(Baseline and Once weekly, through completion of study up to 4 weeks)
- 6 Minute Walk Test(Baseline and Once weekly, through completion of study up to 4 weeks)
- Quality Indicators(Baseline and Once weekly, through completion of study up to 4 weeks)
- Borg Rating of Perceived Exertion(Baseline and Once weekly, through completion of study up to 4 weeks)
- Age-predicted maximum heart rate zone(Each session, through completion of study up to 4 weeks)
- Functional Gait Assessment (FGA)(Baseline and Once weekly, through completion of study up to 4 weeks)
- Berg Balance Scale(Baseline and Once weekly, through completion of study up to 4 weeks)
- Change in step length(Baseline and Once weekly, through completion of study up to 4 weeks)
- Change in stride length(Baseline and Once weekly, through completion of study up to 4 weeks)
- Manual Muscle Test(Baseline and Once weekly, through completion of study up to 4 weeks)
- Modified Ashworth Scale(Baseline and Once weekly, through completion of study up to 4 weeks)
- Change in stride variability(Baseline and Once weekly, through completion of study up to 4 weeks)
- Change in cadence(Baseline and Once weekly, through completion of study up to 4 weeks)
- Passive Range of Motion(Baseline and Once weekly, through completion of study up to 4 weeks)
- Change in bilateral joint torque(Baseline and Once weekly, through completion of study up to 4 weeks)
研究者
Jose Pons
Principal Investigaor
Shirley Ryan AbilityLab