Exoskeletal Support in Stroke

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Oculus Rift headset; Device: Exoskeleton Device

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • NYU Langone Health (222 East 41st Street)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with History of Stroke; 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; 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.; Device: Exoskeleton 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.
Experimental: Healthy Controls; 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; 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.; Device: Exoskeleton 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Contribution (RC)	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.	End of VR Task (Day 1 - session lasts approx. 2 hours)
Muscle Contribution (MC)	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.	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Heidi Schambra, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Actual): April 29, 2024
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 23-00842

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Alexander Brunfeldt, PhD [alexander.brunfeldt@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Alexander Brunfeldt, PhD [alexander.brunfeldt@nyulangone.org]. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No