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Clinical Trials/NCT05996198
NCT05996198
Completed
Not Applicable

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

NYU Langone Health1 site in 1 country19 target enrollmentJanuary 3, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
NYU Langone Health
Enrollment
19
Locations
1
Primary Endpoint
Muscle Contribution (MC)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 3, 2024
End Date
April 29, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Global inattention
  • Legal blindness

Outcomes

Primary Outcomes

Muscle Contribution (MC)

Time Frame: Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)

Muscle Contribution (MC) is a measure of the relative muscle activity between the arms during a bimanual reaching task. Muscle activity was measured using electromyography (EMG); the root-mean-square (RMS) of the EMG timeseries signal in the anterior deltoid. MC in the anterior deltoid was calculated as the RMS in the more-impaired anterior deltoid divided by the sum of RMS values in both anterior deltoids, multiplied by 100. For example, an MC (deltoid) value of 50% indicates that the muscle activity in both anterior deltoids was the same while reaching; an MC value less than 50% indicates that reaching occurred with less muscle activity in the more-impaired deltoid compared to the less-impaired deltoid.

Relative Contribution (RC)

Time Frame: End of VR Task (Day 1 - session lasts approx. 2 hours)

Relative Contribution (RC) is a measure of the relative displacement between the hands during a bimanual reaching task. Displacement of both hands was measured using 3D motion capture using the Oculus Rift VR system. RC is calculated as the displacement of the more-impaired hand divided by the sum of displacements of both hands, multiplied by 100.

Secondary Outcomes

  • Corticospinal Tract (CST) Lesion Load(Baseline)

Study Sites (1)

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