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Clinical Trials/NCT06410989
NCT06410989
Not yet recruiting
Not Applicable

Relating Ankle Impairments to Walking Ability for Characterization of Sensorimotor Function in Individuals With Chronic Stroke

Shirley Ryan AbilityLab1 site in 1 country80 target enrollmentJuly 15, 2025
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Shirley Ryan AbilityLab
Enrollment
80
Locations
1
Primary Endpoint
Sensation and voluntary control of the ankle, quantified by spatiotemporal errors during visuomotor tracking and matching tasks using a robotic ankle device
Status
Not yet recruiting
Last Updated
11 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2025
End Date
August 31, 2027
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jose Pons

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 gait endurance(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 clinical scales of sensation(Assessment during a single 2-hour study visit)

Study Sites (1)

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