Evaluation of Sensorimotor Ankle Impairments in Chronic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06410989
• Other study ID #: STU00219274
• Status: Not yet recruiting
• Start date: May 20, 2024
• Est. completion date: April 14, 2028

Study information

• Verified date: May 2024
• Source: Shirley Ryan AbilityLab
• Contact: Jose L Pons, PhD
• Phone: 312-238-4549
• Email: jpons[@]sralab.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 14, 2028
• Est. primary completion date: April 14, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

• 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

Inclusion criteria specific for healthy participants:

• No neurological disorders

• Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, chronic pain, musculoskeletal injuries)

Inclusion criteria specific for participants post-stroke:

• 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

Exclusion criteria

• 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

Exclusion criteria specific for healthy participants:

• 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)

Exclusion criteria specific for participants post-stroke:

• 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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Assessment during a single 2-hour study visit
Secondary	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.	Assessment during a single 2-hour study visit
Secondary	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.	Assessment during a single 2-hour study visit
Secondary	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.	Assessment during a single 2-hour study visit