Effects of an Overground Propulsion Neuroprosthesis in Community-dwelling Individuals After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Immediate Change in Walking Speed
研究概览
简要总结
This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.
详细描述
This interventional study evaluates the effects of an overground propulsion neuroprosthesis that delivers adaptive neurostimulation assistance to the paretic plantarflexors and dorsiflexors of people post-stroke. Individuals with chronic post-stroke hemiparesis will walk with and without the neuroprosthesis overground and on a treadmill. The goal of the study is to understand how adaptive neurostimulation delivered by the neuroprosthesis affects clinical and biomechanical measures of walking function in order to guide future rehabilitation approaches for restoring walking ability after stroke.
Ten individuals with chronic post-stroke hemiparesis will complete a single session of walking with and without the neuroprosthesis. Study evaluations will be conducted both before and after the session, without the neuroprosthesis active, and during the neuroprosthesis-supported walking.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a stroke event occurring at least 6 months ago
- •Observable gait deficits
- •Independent ambulation for at least 30 meters (using an assistive device as needed but without a rigid brace or ankle foot orthosis)
- •Passive ankle dorsiflexion range of motion to neutral with the knee extended
- •Ability to follow a 3-step command
- •Resting heart rate between 40-100 bpm
- •Resting blood pressure between 90/60 and 170/90 mmHg
- •NIH Stroke Scale Question 1b score > 1 and Question 1c score > 0
- •HIPAA Authorization to allow communication with healthcare provider
- •Medical clearance by a physician
排除标准
- •Severe aphasia or inability to communicate with investigators
- •Neglect or hemianopia
- •Serious comorbidities that may interfere with ability to participate in the research (e.g. musculoskeletal, cardiovascular, pulmonary)
- •Pacemakers or similar electrical implants that could be affected by electrical stimulation
- •Metal implants directly under the stimulation sites
- •Pressure ulcers or skin wounds located near human-device interface sites
- •More than 2 unexplained falls in the previous month
研究组 & 干预措施
Neuroprosthesis-Assisted Walking Evaluation
Participants with chronic stroke will perform a series of short overground walking evaluations at a self-selected fast walking speed with the neuroprosthesis powered and unpowered. When the neuroprosthesis is powered, it provides active neurostimulation assistance for foot clearance and propulsion. When the neuroprosthesis is unpowered, it is worn by the participant but does not provide active assistance.
干预措施: Propulsion Neuroprosthesis (Device)
结局指标
主要结局
Immediate Change in Walking Speed
时间窗: Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in walking speed from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion.
Immediate Change in Paretic Propulsion
时间窗: Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Paretic Propulsion at Non-Preferred Timing
时间窗: Unassisted Walking Condition; Assisted Walking Condition
Paretic propulsion with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Immediate Change in Propulsion Symmetry
时间窗: Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either a non-preferred or a preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Walking Speed at Non-Preferred Timing
时间窗: Unassisted Walking Condition; Assisted Walking Condition
Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway.
Propulsion Symmetry at Non-Preferred Timing
时间窗: Unassisted Walking Condition; Assisted Walking Condition
Propulsion symmetry with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Walking Speed at Preferred Timing
时间窗: Unassisted Walking Condition; Assisted Walking Condition
Walking speed with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway.
Paretic Propulsion at Preferred Timing
时间窗: Unassisted Walking Condition; Assisted Walking Condition
Paretic propulsion with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Paretic Propulsion at Fast Speed
时间窗: Pre-Intervention; Post-Intervention
Paretic propulsion during walking without neurostimulation assistance at a self-selected fast pace during the 10-Meter Walk Test. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Propulsion Symmetry at Preferred Timing
时间窗: Unassisted Walking Condition; Assisted Walking Condition
Propulsion symmetry with or without neurostimulation assistance measured at a self-selected fast pace across a straight 10-meter walkway. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Unassisted Fast Walking Speed
时间窗: Pre-Intervention; Post-Intervention
Walking speed without neurostimulation assistance measured at a self-selected fast pace using the 10-Meter Walk Test.
Unassisted Comfortable Walking Speed
时间窗: Pre-Intervention; Post-Intervention
Walking speed without neurostimulation assistance measured at a self-selected comfortable pace using the 10-Meter Walk Test.
Unassisted Propulsion Symmetry at Fast Speed
时间窗: Pre-Intervention; Post-Intervention
Propulsion symmetry during walking without neurostimulation assistance at a self-selected fast pace during the 10-Meter Walk Test. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Unassisted Paretic Propulsion at Comfortable Speed
时间窗: Pre-Intervention; Post-Intervention
Paretic propulsion during walking without neurostimulation assistance at a self-selected comfortable pace during the 10-Meter Walk Test. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Unassisted Propulsion Symmetry at Comfortable Speed
时间窗: Pre-Intervention; Post-Intervention
Propulsion symmetry during walking without neurostimulation assistance at a self-selected comfortable pace during the 10-Meter Walk Test. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Immediate Change in Walking Speed
时间窗: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
Change in walking speed from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (after mid-stance).
Immediate Change in Paretic Propulsion
时间窗: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (after mid-stance). Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Immediate Change in Propulsion Symmetry
时间窗: Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance)
Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either an early or a late timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (after mid-stance). Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Immediate Change in Walking Speed
时间窗: Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in walking speed from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion.
Immediate Change in Propulsion Symmetry
时间窗: Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Immediate Change in Paretic Propulsion
时间窗: Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
Immediate Change in Propulsion Symmetry
时间窗: Early Neurostimulation Timing Condition (40% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in propulsion symmetry from unassisted walking to walking with neurostimulation assistance at either an early timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Early timing of plantarflexor neurostimulation was delivered at 40% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Propulsion symmetry was calculated as the propulsion impulse of the paretic limb divided by the total propulsion impulse (paretic + nonparetic). Propulsion impulse is the area under the positive portion of the anterior-posterior ground reaction force curve.
Immediate Change in Walking Speed
时间窗: Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in walking speed from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (before mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion.
Immediate Change in Paretic Propulsion
时间窗: Late Neurostimulation Timing Condition (60% stance); Preferred Neurostimulation Timing Condition (propulsion-based tuning)
Change in paretic propulsion from unassisted walking to walking with neurostimulation assistance at either a late timing or an individual-specific preferred timing, measured at a self-selected fast pace across a straight 10-meter walkway. Late timing of plantarflexor neurostimulation was delivered at 60% of paretic limb support phase (after mid-stance). Timing preference was determined for each participant individually based on which of the early or late timings produced greater paretic propulsion. Paretic propulsion was calculated as the peak anterior-posterior ground reaction force of the paretic limb.
次要结局
- Plantarflexor Power at Non-Preferred Timing(Unassisted Walking Condition; Assisted Walking Condition)
- Plantarflexor Power at Preferred Timing(Unassisted Walking Condition; Assisted Walking Condition)
- Unassisted Dorsiflexion Angle at Fast Speed(Pre-Intervention; Post-Intervention)
- Unassisted Plantarflexor Power at Fast Speed(Pre-Intervention; Post-Intervention)
- Unassisted Dorsiflexion Angle at Comfortable Speed(Pre-Intervention; Post-Intervention)
- Unassisted Plantarflexor Power at Comfortable Speed(Pre-Intervention; Post-Intervention)
- Dorsiflexion Angle at Preferred Timing(Unassisted Walking Condition; Assisted Walking Condition)
- Dorsiflexion Angle at Non-Preferred Timing(Unassisted Walking Condition; Assisted Walking Condition)
- Onset Timing of Plantarflexor Neurostimulation(Early Neurostimulation Timing Condition (40% stance); Late Neurostimulation Timing Condition (60% stance))
- Preferred Neurostimulation Timing(Preferred Neurostimulation Timing Condition (propulsion-based tuning))
- Dorsiflexion Angle (No Dorsiflexor Impairment)(Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning))
- Dorsiflexion Angle (With Dorsiflexor Impairment)(Pre-Intervention; Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning))
- Immediate Change in Dorsiflexion Angle(Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning))
- Immediate Change in Plantarflexor Power(Non-Preferred Neurostimulation Timing Condition (propulsion-based tuning); Preferred Neurostimulation Timing Condition (propulsion-based tuning))
研究者
Lou Awad, PT, DPT, PhD
Professor
Boston University Charles River Campus