The Effects of Muscle Synergy-Based Biofeedback During Gait Rehabilitation for Individuals With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in muscle synergies during walking
研究概览
简要总结
The purpose of this study is to compare two interventions currently used to improve gait and lower limb function in individuals with chronic stroke (i.e., high-intensity gait training and high-intensity gait training with functional electrical stimulation (FES)) with novel interventions based on the coordinated activity of multiple muscles, known as muscle synergies. To this end, the researchers will recruit chronic stroke patients to participate in training protocols according to the currently used rehabilitation programs as well as novel rehabilitation programs that provide real time feedback of muscle synergies using multichannel FES and visual feedback.
详细描述
The researchers will determine if using muscle synergies to drive interventions provides greater rehabilitation outcomes than the interventions that are currently used in therapy. Then, the researchers aim to investigate which modality of feedback (somatosensory vs visual) on muscle synergies may result in the greatest improvements. Therefore, we will have two aims. The main objective of Aim 1 of this study is to compare 1) conventional high-intensity gait training, 2) standard FES gait training, and 3) a novel muscle synergy-based multichannel FES (MFES) gait training for the purpose of improving lower limb function (i.e., gait) in individuals with chronic stroke. The main objective of Aim 2 of this study is to compare 1) muscle synergy-based MFES gait training, 2) muscle synergy visual biofeedback gait training, and 3) a combination of synergy-based MFES and muscle synergy visual biofeedback gait training to determine the key modality to driving neuroplastic change in the organization of muscle synergies during gait training. To this end, the researchers will randomly enroll 15 patients with chronic stroke to one of the three rehabilitation programs/groups listed above in each aim and assess the efficacy of each program to improve the following patient outcomes throughout and following rehabilitation:
- Changes in functional impairment measured by clinical assessments.
- Changes in gait biomechanics.
- Electrophysiological changes in motor control.
- Feasibility of clinical use of novel interventions and the perceived usefulness by patients.
This will provide information about the potential advantages of using the novel synergy-based biofeedback systems in a chronic stroke population and may be the foundation for a larger clinical trial and extension of this rehabilitation technology to the subacute stroke population as well as other neurologically impaired populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors who do not know subject group assignments will perform the assessments.
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants:
- •Inclusion Criteria:
- •Age 18-80 years, inclusive
- •Normal hearing and vision, can be corrected
- •Able to understand and give informed consent
- •Able to understand and speak English
排除标准
- •Reduced cognitive function or inability to perform study tasks
- •Any neurological disorder or history of neurological injuries (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, peripheral nerve injury, or cancer of the central nervous system)
- •Presence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, marked arthritis, chronic pain, musculoskeletal injuries)
- •Recent fracture or osteoporosis (as reported by subject)
- •Lesions or wounds on the legs
- •Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures
- •Pregnancy
- •Prisoners
- •Inclusion Criteria:
- •Age 18-80 years, inclusive
- •Normal hearing and vision, can be corrected
- •History of a single unilateral, supratentorial ischemic or hemorrhagic stroke at least six months prior
- •Reduced ambulation but able to walk >10m independently on level ground (with assistive device if needed)
- •Medical clearance from medical team (signed Medical Clearance form)
- •Able to understand and give informed consent
- •Able to understand and speak English
- •Able to passively move all joints (i.e., hip, knee, ankle) through the range of motion of a typical gait cycle
- •Exclusion Criteria:
- •Reduced cognitive function and inability to perform study tasks
- •Severe aphasia
- •Co-existence of other neurological diseases (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system)
- •History of peripheral nerve injury
- •Severe hip, knee, or ankle arthritis
- •Recent fracture or osteoporosis (as reported by subject)
- •Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures
- •Significant spasticity or contracture in the lower limbs (Modified Ashworth Scale score of 3 or higher)
- •Use of pacemakers, defibrillators, electrical implants, or metallic implants
- •Lesions or wounds on the paretic leg
- •Botox (botulinum toxin) injection to lower limbs within the prior 3 months, or planned injection during study period
- •Pregnancy
- •Prisoners
- •Concurrent or planned participation in surgeries, significant medical treatments, other lower limb research studies, or physical therapy during the study timeline
- •Therapists:
- •Inclusion Criteria:
- •Licensed physical therapist at SRALab
- •At least 1 year of experience as a physical therapist
- •Regularly treats people with stroke, at minimum once per week
- •Able to give informed consent
- •Active CITI training certification, or willing to complete this online CITI training
- •Exclusion Criteria:
- •Inability to interact safety with the technologies
- •Unwillingness to try to use the technologies
- •Unable to complete at least 1 competency session and deliver at least 6 intervention sessions
研究组 & 干预措施
Standard FES to the Tibialis Anterior (TA)
Participants in the standard FES gait training group will receive FES applied to the TA muscle/peroneal nerve on his/her more affected leg. FES strategically stimulates the TA/peroneal nerve at specific phases of the gait cycle identified by internal inertial measurement units (IMUs).
干预措施: Standard FES to the Tibialis Anterior (TA) (Device)
Conventional High Intensity Gait Training
Participants in the conventional high-intensity gait training group will undergo gait training on a treadmill. Each session will consist of between 30-60 minutes of walking targeted to reach a high intensity, as measured via heart rate and Borg rating of perceived exertion. This may also include inclined walking, walking with an ankle weight, backwards walking, sidestepping, and/or obstacle walking.
干预措施: Conventional High Intensity Gait Training (Device)
Synergy-Based Multichannel FES (MFES)
Participants in the synergy-based MFES gait training group will receive FES applied to muscles of the affected lower limb. These muscles may include the TA, gastrocnemius medialis, gastrocnemius lateralis, soleus, rectus femoris, vastus medialis, vastus lateralis, semitendinosus, biceps femoris, gluteus medius, and adductor longus. FES will be applied to each muscle with an activation pattern that is derived from extracted healthy muscle synergies that are scaled to fit the patient's gait cycle.
干预措施: Synergy-Based Multichannel FES (MFES) (Device)
Muscle Synergy Visual Biofeedback
Participants in the muscle synergy visual biofeedback group will wear bipolar EMG sensors on the muscles of interest. In real time, muscle synergies will be extracted and the similarity of affected synergies to healthy synergies will be displayed on a screen. Patients in this group will be instructed to try to increase the similarity score of the affected synergies and the healthy synergies. No electrical stimulation will be provided in this group.
干预措施: Muscle Synergy Visual Biofeedback (Device)
Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback
Participants in the group will receive a combination of the synergy-based MFES and muscle synergy visual biofeedback interventions. Because EMG cannot be recorded while FES is being applied in a continuous fashion, this method will alternate between providing sensory feedback (FES) and visual feedback of the muscle synergies.
干预措施: Synergy-Based Multichannel FES (MFES) (Device)
Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback
Participants in the group will receive a combination of the synergy-based MFES and muscle synergy visual biofeedback interventions. Because EMG cannot be recorded while FES is being applied in a continuous fashion, this method will alternate between providing sensory feedback (FES) and visual feedback of the muscle synergies.
干预措施: Muscle Synergy Visual Biofeedback (Device)
结局指标
主要结局
Change in muscle synergies during walking
时间窗: Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions
Muscle synergies are groups of muscles that receive a common input from the brain. The researchers will assess the number of muscle synergies and the similarity of muscle synergies to those of healthy individuals. The researchers will calculate from the electromyographic (EMG) activity and compare the number and similarity of muscle synergies to healthy individuals via a similarity index. These measures will be assessed between legs, over time, and between groups. An increase in number of synergies and an improvement in similarity of synergies is a better outcome.
次要结局
- Change in Berg Balance Scale(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in 10 Meter Walk Test(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in 6 Minute Walk Test(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Functional Gait Assessment (FGA)(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Borg Rating of Perceived Exertion(Each session through completion of study, up to 6 weeks)
- Change in joint angle(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in EMG Magnitude and Gait Phase Components of Muscle Activity(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Modified Ashworth Scale(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Global Rating of Change(Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions for post-stroke participants; every 5-8 sessions delivered per intervention for therapist participants)
- Change in joint velocity(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Manual Muscle Test(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in cadence(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Patient Questionnaire(Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in time spent in age-predicted maximum heart rate zone(Each session through completion of study, up to 6 weeks)
- Change in Step Count(One week prior to initiating training sessions, and one week following the conclusion of all training sessions)
- Change in stance time(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Therapist Questionnaire(Every 5-8 sessions (e.g., 2-3 weeks) of administering a particular intervention)
- Change in Preparation and Breakdown Time(Every training session over 6 weeks with 3 training sessions per week)
- Change in System Usability Scale(Every 5-8 sessions (e.g., 2-3 weeks) delivered by the therapist per intervention)
- Change in "The Acceptability of Intervention Measure, Intervention Appropriateness Measure, and Feasibility of Intervention Measure"(Every 5-8 sessions (e.g., 2-3 weeks) delivered by the therapist per intervention)
- Change in stride time variability(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in stride length(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in variation in center of gravity(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
- Change in Neural synergies(Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions)
研究者
Jose Pons
Principal Investigator
Shirley Ryan AbilityLab