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Clinical Trials/NCT04805866
NCT04805866
Active, not recruiting
Not Applicable

Tracking Neural Synergies During Gait Rehabilitation After Stroke

Shirley Ryan AbilityLab1 site in 1 country36 target enrollmentJune 9, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Shirley Ryan AbilityLab
Enrollment
36
Locations
1
Primary Endpoint
Change in Neural Synergies
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
June 9, 2021
End Date
July 31, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Pons

Principal Investigaor

Shirley Ryan AbilityLab

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Neural Synergies

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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