Evaluation of Sensorimotor Ankle Impairments in Chronic Stroke

NCT06410989 | Not Yet Recruiting

• 1 other identifier: STU00219274
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

Robotic Rehabilitation; Sensorimotor function; Proprioception; Motor Control; Ankle Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessment during a single 2-hour study visit

Secondary Outcomes (4)

• Correlation between spatiotemporal ankle control and clinical measurement of ankle control

  Assessment during a single 2-hour study visit

• Correlation between spatiotemporal ankle control and spatiotemporal gait measures during overground walking

  Assessment during a single 2-hour study visit

• Correlation between spatiotemporal ankle control and gait endurance

  Assessment during a single 2-hour study visit

• Correlation between spatiotemporal ankle control and clinical scales of sensation

  Assessment during a single 2-hour study visit

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic patients post-stroke and healthy individuals as controls

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose L Pons, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose L Pons, PhD

CONTACT

312-238-4549; jpons@sralab.org

Grace W Hoo, MS

CONTACT

312-238-4548; ghoo@sralab.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: July 15, 2025
• Primary Completion: August 31, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)