Clinical trial NCT04805866: Tracking Neural Synergies After Stroke.
Official title: Tracking Neural Synergies During Gait Rehabilitation After Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stroke
Keywords: Stroke
Electromyography
Gait rehabilitation
Balance
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals poststroke that are inpatients at Shirley Ryan AbilityLab and Healthy individuals as age-matched controls

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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

Exclusion Criteria:

* 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

Patients:

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

Primary outcomes:
measure: Change in Neural Synergies
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: 6 Minute Walk Test
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Berg Balance Scale
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Quality Indicators
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Manual Muscle Test
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Modified Ashworth Scale
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Step count
timeFrame: Each session, through completion of study up to 4 weeks
measure: Age-predicted maximum heart rate zone
timeFrame: Each session, through completion of study up to 4 weeks
measure: Borg Rating of Perceived Exertion
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Passive Range of Motion
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Change in stride variability
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Change in cadence
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Change in step length
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Change in stride length
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Change in stance time
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
measure: Change in bilateral joint torque
timeFrame: Baseline and Once weekly, through completion of study up to 4 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Jose L Pons, PhD
role: PRINCIPAL_INVESTIGATOR
References: