StrokeNCT04805866
Tracking Neural Synergies After Stroke.
An observational study of Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 15 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals poststroke that are inpatients at Shirley Ryan AbilityLab and Healthy individuals as age-matched controls
Who may be able to join
- 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
- Age 18-85 years old
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tracking Neural Synergies During Gait Rehabilitation After Stroke
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).
Read the 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).
- Conditions
- Stroke
- Keywords
- Stroke, Electromyography, Gait rehabilitation, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Secondary outcomes (17)
10 Meter Walk Test
The 10 Meter Walk Test is a common clinical measure of gait speed. Participants will be directed to walk at their comfortable, self-selected speed. Participants will be positioned at the start line and instructed to walk the entire 10 meter distance while the therapist times the middle six meters. The distance before and after the timed course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.46 sec). The test will be performed two times at self-selected speed with adequate rest in between. The average of the two times should be recorded. The test will then be repeated with the participants directed to walk at their fast but safe speed. Appropriate assistive devices, bracing, and the minimal amount of physical assistance from the physical therapist will be applied.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
6 Minute Walk Test
The 6 Minute Walk Test measures the distance a participant can walk indoors on a flat, hard surface in a period of six minutes. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test is self-paced. Participants are allowed to stop and rest during the test; however, the timer does not stop. If a participant is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded. Appropriate assistive devices, bracing, and the minimal amount of physical assistance from the physical therapist will be applied.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Berg Balance Scale
The Berg Balance Scale is a 14-item test, scored on a five point ordinal scale. It measures functional balance in a clinical setting and includes static and dynamic tasks (such as sitting, standing, transitioning from sitting to standing, standing on one foot, retrieving an object from the floor), during which participants must maintain their balance.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Quality Indicators
This is a standardized, evidence-based measure of health care quality used to track clinical performance and outcomes in post-acute care. Items are scored on a six point ordinal scale, ranging from independent to dependent. Items can also be coded as participant refuses, not applicable, environmental limitations, not attempted due to medical condition or safety concerns, or unplanned discharge.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Manual Muscle Test
Manual Muscle Test is a procedure for evaluating the strength of 16 individual muscles relative to gravity and manual resistance. Instructions are provided to the participant before testing each muscle. A muscle is isolated, and gradual external force is applied at a right angle to the muscle's long axis. Each muscle is scored on a graded scale of "weak" to "strong" based on the participant's ability to resist the external force. The test is first completed for muscles on the unimpaired side to determine normal strength before being repeated on the impaired side. Weaker participants may be tested while lying prone (gravity eliminated).
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Modified Ashworth Scale
The Modified Ashworth Scale is a 6-point ordinal scale used to grade the amount of hypertonicity in individuals with neurological diagnoses. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Step count
The number of steps taken during each session will be measured using ActiGraph GT9X Link activity monitors. These devices are small accelerometers that can be worn on a belt and/or on the ankle to record steps and Kcals during an activity. The therapist leading the intervention session will apply the ActiGraph at the beginning of each intervention session and remove it upon completion.
Measured: Each session, through completion of study up to 4 weeks
Age-predicted maximum heart rate zone
The target range of 70-85% of age-predicted maximum heart rate will be calculated for each participant utilizing HRmax = 208 - [0.7 × age] as developed by Tanka et al in 2001. It is recommended that clinicians should apply moderate to high-intensity walking training to improve walking speed and endurance individuals poststroke. The researchers will record the amount of time participants spend in their pre-calculated target zone during each gait training session utilizing the Polar OH1 Optical Heart Rate Sensor.
Measured: Each session, through completion of study up to 4 weeks
Borg Rating of Perceived Exertion
The Borg Rating of Perceived Exertion is a tool to measure the subjective report of effort, exertion, and fatigue during physical work. It consists of a 15-point scale from 6-20, in which 6=no exertion and 20=absolute maximum exertion. It is presented to the participant in written format with descriptors to standardize the report of perceived exertion across tasks.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Functional Gait Assessment (FGA)
The FGA is a 10-item test, scored on a four point ordinal scale. A higher score indicates decreased fall risk. It measures dynamic balance and postural stability during walking tasks (such as fast walking, backward walking, stepping over an obstacle) in the clinical setting. Patients are allowed to use an assistive device for certain items.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Passive Range of Motion
The purpose of this test is to evaluate a participant's passive range of motion in the joints of the hips, knees, and ankles. A larger range of motion indicates a better outcome.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Change in stride variability
Stride variability is the ratio between the standard-deviation and mean of stride time, expressed as percentage. Decreased variability indicates a better outcome.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Change in cadence
Cadence is the total number of steps taken within a given time period; often expressed per minute. Typically a higher number of steps is a better outcome.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Change in step length
Step length is the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot. Typically a longer step length is a better outcome, ideally with equal measurements between left and right limbs.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Change in stride length
Between successive points of initial contact of the same foot. Right and left stride lengths are normally equal. Typically a longer stride length is a better outcome, ideally with equal measurements between left and right limbs.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Change in stance time
Stance time is the amount of time that passes during the stance phase of one extremity in a gait cycle. It includes single support and double support. Equal stance time between limbs is a better outcome.
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Change in bilateral joint torque
Joint torque is the sum of passive and active torques of the human limb. Passive torques are produced by tension developed as muscle tissue, tendons, and ligaments are stretched. Active torque is the torque produced by the muscles. Typically lower joint torque during movement is a better outcome. This will be measured in the ankle, knee, and hip bilaterally
Measured: Baseline and Once weekly, through completion of study up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start9 Jun 2021
- Primary completion21 Feb 2024
- Study completion15 Jul 2026 (estimated)
Why it stopped: Study pending of funding that could not be secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Pons, Shirley Ryan AbilityLab
- Investigators
- Jose L Pons, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805866
- Sponsor's protocol ID
- STU00214290
- Status last verified
- Jul 2026
- First submitted
- 15 Mar 2021
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Neural Synergies During Gait Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT04805866
- Acronym / sponsor ID
- STU00214290
- Conditions
- Stroke
- Keywords
- Stroke, Electromyography, Gait rehabilitation, Balance
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study pending of funding that could not be secured
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals poststroke that are inpatients at Shirley Ryan AbilityLab and Healthy individuals as age-matched controls
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
17 secondary outcomes
10 Meter Walk Test
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
6 Minute Walk Test
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Berg Balance Scale
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Quality Indicators
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Manual Muscle Test
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Modified Ashworth Scale
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Step count
Time frame: Each session, through completion of study up to 4 weeks
Age-predicted maximum heart rate zone
Time frame: Each session, through completion of study up to 4 weeks
Borg Rating of Perceived Exertion
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Functional Gait Assessment (FGA)
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Passive Range of Motion
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Change in stride variability
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Change in cadence
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Change in step length
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Change in stride length
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Change in stance time
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Change in bilateral joint torque
Time frame: Baseline and Once weekly, through completion of study up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Pons, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neural Synergies (time frame: Baseline and Once weekly, through completion of study up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.