Exoskeletal Support in Stroke

Study Overview
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Brief Summary
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This interventional study will measure motor performance, including 3D movement analysis and muscle activity, in response to exoskeleton assistance. The cohort design will compare stroke patients to healthy controls. Data collection will be conducted in a single, 2-hour session. Investigators will also access stroke patients' brain MRIs that were obtained as standard of care during acute admission for stroke.

Official Title
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A Pilot Proof of Concept, Single Site Study to Assess the Effect of Exoskeletal Support on Motor Control Strategies in Individuals With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Oculus Rift headset
* Device: Exoskeleton Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy controls: Having obtained the age of 18 years Neurologically healthy (i.e., no history of: traumatic brain injury, peripheral neuropathy, seizures, etc.) Strongly right-handed according to at least 80% score on the Edinburgh Handedness Inventory (Oldfield, 1971; Veale, 2013). The use of right-handed participants is a common feature in this field of study. This is due to the slight differences in arm control between left- and right-handed individuals (Sainburg & Kalakanis, 2000). Ability to give informed consent Survivors of stroke: Having obtained the age of 18 years have a diagnosis of stroke more than six months prior to entry into the study; have the ability to reach, unsupported, to approximately 70% of arm length ability to give informed consent Exclusion Criteria: All participants have any conditions that limit their capability of using a Head Mounted Display (HMD) for a VR environment or cooperate with the protocol. have any orthopedic injuries to the upper extremities. Have neurological injuries other than stroke. Have excessive pain in any joint of either arm that could limit the ability to cooperate with the protocols. Visuospatial neglect Apraxia Global inattention Legal blindness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with History of Stroke<br>Individuals with history of stroke more than 6 months prior to enrollment. Participants will complete 3 blocks of 54 trials in a single session. Block 1 is a baseline phase where subjects will perform reaches without any loads applied via the exoskeleton devices. Block 2 is the intervention block where bilateral exoskeletons apply gravity assistance to the impaired arm for stroke survivors and gravity resistance to the non-impaired arm. Block 3 is a retention block, where tested procedures are identical to block 1. | Device: Oculus Rift headset<br>* The Oculus Rift is a commercially-available virtual reality (VR) headset. It is used to present the visual environment in which participants perform the reaching task.<br>Device: Exoskeleton Device<br>* The exoskeleton was designed and constructed to provide either gravity assistance or gravity resistance. It applies a torque to both shoulders. Torque values do not exceed 50% of the torque due to gravity. The device is mounted to a testing chair and attached to the participant using Velcro straps.<br>|
| Experimental: Healthy Controls<br>Healthy age and gender-matched control participants. Participants will complete 3 blocks of 54 trials in a single session. Block 1 is a baseline phase where subjects will perform reaches without any loads applied via the exoskeleton devices. Block 2 is the intervention block where bilateral exoskeletons apply gravity assistance to the non-dominant arm and resistance is applied to the dominant arm in healthy controls. Block 3 is a retention block, where tested procedures are identical to block 1. | Device: Oculus Rift headset<br>* The Oculus Rift is a commercially-available virtual reality (VR) headset. It is used to present the visual environment in which participants perform the reaching task.<br>Device: Exoskeleton Device<br>* The exoskeleton was designed and constructed to provide either gravity assistance or gravity resistance. It applies a torque to both shoulders. Torque values do not exceed 50% of the torque due to gravity. The device is mounted to a testing chair and attached to the participant using Velcro straps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Relative Contribution (RC) Level | Measured via arm trajectory analysis as a percentage (%); evaluates arm control. | Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours) | 
| Change in Muscle Contribution (MC) Level | Measured via electromyographical analysis as a percentage (%); evaluates arm control. | Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corticospinal Tract (CST) Lesion Load | Measured via MRI; lesion load is expressed as percentage of the entire CST. | Baseline |