StrokeNCT06410989
Evaluation of Sensorimotor Ankle Impairments in Chronic 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 capture sensorimotor ankle function in a chronic stroke population through validation of novel, experimental metrics and their comparison with established, clinical measures of function. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic patients post-stroke and healthy individuals as controls
Who may be able to join
- 40 - 80 years of age, inclusive
- Normal hearing and vision, can be corrected
- No skin allergies to adhesive material, conductive paste, or silver
- Ability to walk >10m independently on level ground without an assistive device or bracing
- Able to understand and give informed consent
- Able to understand and speak English
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- No neurological disorders
- Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, chronic pain, musculoskeletal injuries)
- Unilateral, supratentorial ischemic or hemorrhagic stroke ≥ six months prior
- Minimum activation against gravity for dorsiflexion and plantarflexion, equivalent to a Manual Muscle Test (MMT) score of ≥ +2
- Self-selected walking speed is less than 1.2 m/s
Who cannot join
- Cognitive limitations that would prevent playing games
- Adults unable to consent, pregnant women, children, or prisoners
- Infection, wounds, or graft sites on lower limbs
- History of sustained non-prescribed drug use or substance abuse (as reported by subject; current nicotine use is allowed)
- History of peripheral nerve injury
- Severe hip, knee, or ankle arthritis
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- Recent fracture or osteoporosis (as reported by subject)
- Bone or joint instability in the lower limb
- Severe pain syndromes affecting any part of the lower limbs
- Fixed contractures affecting the lower limbs
- Medical (cardiac, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures
- Inability or unwillingness to perform study-required activities
- Prior neurosurgical procedures
- Any neurological diseases (e.g., stroke, Parkinson's disease or other neurodegenerative disorder, severe dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system)
- Co-existence of other neurological diseases (e.g., Parkinson's disease or other neurodegenerative disorder, severe dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system)
- Botox (botulinum toxin) injection to lower limbs within the prior 3 months
- Significant spasticity or contracture in the lower limbs (Modified Ashworth Scale score of 4)
- Severe aphasia
- Significant loss of sensation in the lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relating Ankle Impairments to Walking Ability for Characterization of Sensorimotor Function in Individuals With Chronic Stroke
The purpose of this study is to capture sensorimotor ankle function in a chronic stroke population through validation of novel, experimental metrics and their comparison with established, clinical measures of function. For this purpose, the researchers will evaluate various single-joint, impairment-level measures such as visuomotor tracking performance and proprioception as well as functional-level measures including spatiotemporal gait (e.g., gait speed and stride length/time) and standardized clinical scales. This study will be carried out in chronic stroke patients as well as age-matched healthy controls. Results will help the researchers identify more quantitative metrics that can be used to monitor and rehabilitate sensorimotor function following stroke.
Read the detailed description
The purpose of this study is to capture sensorimotor ankle function in a chronic stroke population through validation of novel, experimental metrics and their comparison with established, clinical measures of function. Target populations will perform various single-joint ankle tasks (i.e., dorsiflexion and plantarflexion), assessing the quality of their movements during visuomotor tracking, goal-directed movements and unilateral/bilateral tests of joint position and force sense. Collecting these data will delineate which measures of ankle function are specific to chronic stroke, as well as sensitivity to the severity of stroke, assessed via the Fugl-Meyer Assessment for the Lower Extremity. In addition, the investigators will determine the relationship between deficits in proprioception and assessments which integrate multiple feedback modalities (i.e., proprioception, motor control and vision) to assess the role of peripheral sensory feedback in performing ankle movements post-stroke. The investigators will correlate measures of ankle impairment to clinical scales commonly used in physical therapy. As a first step, the investigators will directly compare these ankle measures to clinical tests of ankle sensation and motor control to demonstrate improvements in assessment sensitivity with this method. Furthermore, the investigators will correlate these ankle measures with clinical measures of lower-limb function during ambulatory and balance tasks, to better understand the contribution of ankle impairments to dynamic, multi-joint activities in chronic stroke.
- Conditions
- Stroke
- Keywords
- Robotic Rehabilitation, Sensorimotor function, Proprioception, Motor Control, Ankle Rehabilitation
- 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 |
|---|---|---|
| Chronic patients post-stroke | Patients post-stroke, age 40-80, with a unilateral supratentorial ischemic or hemorrhagic stroke | |
| Healthy Individuals | Healthy adults, age 40-80, without neurological disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensation and voluntary control of the ankle, quantified by spatiotemporal errors during visuomotor tracking and matching tasks using a robotic ankle device
Ankle function will be measured with a robotic device while the participant performs various dorsiflexion and plantarflexion movements to evaluate their ankle motor control and proprioception. For the visuomotor tracking tasks, participants will repetitively perform a specified movement, guided by visual feedback of their own input and a target movement to follow. In the matching tasks, participants will be asked to reproduce different ankle configurations (i.e., maintaining a target force or position) based on their memory of previous configurations. In both tasks, errors between the target movement and the participant's movement will be compared between chronic stroke and age-matched cohorts to characterize ankle deficits associated with stroke.
Measured: Assessment during a single 2-hour study visit
Secondary outcomes (4)
Correlation between spatiotemporal ankle control and clinical measurement of ankle control
The Manual Muscle Test (MMT) will be used as a measure of voluntary ankle control and compared to the spatiotemporal errors defined in the primary outcome measures section.
Measured: Assessment during a single 2-hour study visit
Correlation between spatiotemporal ankle control and spatiotemporal gait measures during overground walking
The 10 meter walk test will be used to measure the participant's comfortable walking speed and spatiotemporal gait parameters (i.e., stride length and stride time); these measures will be compared to the spatiotemporal errors defined in the primary outcome measures section.
Measured: Assessment during a single 2-hour study visit
Correlation between spatiotemporal ankle control and gait endurance
The 6 minute walk test will be used to measure the participant's endurance during gait and will be compared to the spatiotemporal errors defined in the primary outcome measures section.
Measured: Assessment during a single 2-hour study visit
Correlation between spatiotemporal ankle control and clinical scales of sensation
The Monofilament test will be used to measure the participant's touch sensitivity at the ankle and will be compared to the spatiotemporal errors defined in the primary outcome measures section.
Measured: Assessment during a single 2-hour study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start15 Jul 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Why it stopped: The study personnel left the institution and no alternative funding could be secured to implement the study
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.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
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
- NCT06410989
- Sponsor's protocol ID
- STU00219274
- Status last verified
- Jul 2026
- First submitted
- 8 May 2024
- 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
- Relating Ankle Impairments to Walking Ability for Characterization of Sensorimotor Function in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT06410989
- Acronym / sponsor ID
- STU00219274
- Conditions
- Stroke
- Keywords
- Robotic Rehabilitation, Sensorimotor function, Proprioception, Motor Control, Ankle Rehabilitation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: The study personnel left the institution and no alternative funding could be secured to implement the study
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 13 May 2024 (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 capture sensorimotor ankle function in a chronic stroke population through validation of novel, experimental metrics and their comparison with established, clinical measures of function. For this purpose, the researchers will evaluate various single-joint, impairment-level measures such as visuomotor tracking performance and proprioception as well as functional-level measures including spatiotemporal gait (e.g., gait speed and stride length/time) and standardized clinical scales. This study will be carried out in chronic stroke patients as well as age-matched healthy controls. Results will help the researchers identify more quantitative metrics that can be used to monitor and rehabilitate sensorimotor function following stroke.
Detailed description
The purpose of this study is to capture sensorimotor ankle function in a chronic stroke population through validation of novel, experimental metrics and their comparison with established, clinical measures of function. Target populations will perform various single-joint ankle tasks (i.e., dorsiflexion and plantarflexion), assessing the quality of their movements during visuomotor tracking, goal-directed movements and unilateral/bilateral tests of joint position and force sense. Collecting these data will delineate which measures of ankle function are specific to chronic stroke, as well as sensitivity to the severity of stroke, assessed via the Fugl-Meyer Assessment for the Lower Extremity. In addition, the investigators will determine the relationship between deficits in proprioception and assessments which integrate multiple feedback modalities (i.e., proprioception, motor control and vision) to assess the role of peripheral sensory feedback in performing ankle movements post-stroke. The investigators will correlate measures of ankle impairment to clinical scales commonly used in physical therapy. As a first step, the investigators will directly compare these ankle measures to clinical tests of ankle sensation and motor control to demonstrate improvements in assessment sensitivity with this method. Furthermore, the investigators will correlate these ankle measures with clinical measures of lower-limb function during ambulatory and balance tasks, to better understand the contribution of ankle impairments to dynamic, multi-joint activities in chronic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic patients post-stroke | – | –Patients post-stroke, age 40-80, with a unilateral supratentorial ischemic or hemorrhagic stroke |
| Healthy Individuals | – | –Healthy adults, age 40-80, without neurological disorders |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic patients post-stroke and healthy individuals as controls
Key inclusion criteria (11 listed)
- 40 - 80 years of age, inclusive
- Normal hearing and vision, can be corrected
- No skin allergies to adhesive material, conductive paste, or silver
- Ability to walk >10m independently on level ground without an assistive device or bracing
- Able to understand and give informed consent
Key exclusion criteria (19 listed)
- Cognitive limitations that would prevent playing games
- Adults unable to consent, pregnant women, children, or prisoners
- Infection, wounds, or graft sites on lower limbs
- History of sustained non-prescribed drug use or substance abuse (as reported by subject; current nicotine use is allowed)
- History of peripheral nerve injury
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
Sensation and voluntary control of the ankle, quantified by spatiotemporal errors during visuomotor tracking and matching tasks using a robotic ankle device
Time frame: Assessment during a single 2-hour study visit
Ankle function will be measured with a robotic device while the participant performs various dorsiflexion and plantarflexion movements to evaluate their ankle motor control and proprioception. For the visuomotor tracking tasks, participants will repetitively perform a specified movement, guided by visual feedback of their own input and a target movement to follow. In the matching tasks, participants will be asked to reproduce different ankle configurations (i.e., maintaining a target force or position) based on their memory of previous configurations. In both tasks, errors between the target movement and the participant's movement will be compared between chronic stroke and age-matched cohorts to characterize ankle deficits associated with stroke.
4 secondary outcomes
Correlation between spatiotemporal ankle control and clinical measurement of ankle control
Time frame: Assessment during a single 2-hour study visit
Correlation between spatiotemporal ankle control and spatiotemporal gait measures during overground walking
Time frame: Assessment during a single 2-hour study visit
Correlation between spatiotemporal ankle control and gait endurance
Time frame: Assessment during a single 2-hour study visit
Correlation between spatiotemporal ankle control and clinical scales of sensation
Time frame: Assessment during a single 2-hour study visit
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 11 inclusion and 19 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?
Sensation and voluntary control of the ankle, quantified by spatiotemporal errors during visuomotor tracking and matching tasks using a robotic ankle device (time frame: Assessment during a single 2-hour study visit). 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.