NCT04805866

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).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

March 15, 2021

Last Update Submit

May 21, 2025

Conditions

Stroke

Keywords

StrokeElectromyographyGait rehabilitationBalance

Outcome Measures

Primary Outcomes (1)

  • Change in Neural Synergies

    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

    Baseline and Once weekly, through completion of study up to 4 weeks

Secondary Outcomes (17)

  • 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

  • Berg Balance Scale

    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

  • Manual Muscle Test

    Baseline and Once weekly, through completion of study up to 4 weeks

  • +12 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals poststroke that are inpatients at Shirley Ryan AbilityLab and Healthy individuals as age-matched controls

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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)
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jose L Pons, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigaor

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 18, 2021

Study Start

June 9, 2021

Primary Completion

February 21, 2024

Study Completion

July 31, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)