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OpenTrials
Completed

NCT Number: NCT05996198

Exoskeletal Support in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health (222 East 41st Street)

New York, 10017, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oculus Rift headset

Device

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.

Exoskeleton Device

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Corticospinal Tract (CST) Lesion Load

    Time frame: Baseline

    Measured via MRI; lesion load is expressed as percentage of the entire CST.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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