Evaluation of Sensorimotor Ankle Impairments in Chronic Stroke
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShirley Ryan AbilityLab
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Chronic patients post-stroke and healthy individuals as controls
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
80 Participants
are grouped into 2 trial groupsGroup A: Chronic patients post-stroke
Group B: Healthy Individuals
Trial outcomes
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.
Time frame
Assessment during a single 2-hour study visitSecondary outcomes
1
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.
Time frame
Assessment during a single 2-hour study visit2
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.
Time frame
Assessment during a single 2-hour study visit3
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.
Time frame
Assessment during a single 2-hour study visit4
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.
Time frame
Assessment during a single 2-hour study visitSponsors and contacts
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Source ClinicalTrials.gov
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