Exoskeletal Support in Stroke

NCT05996198 | Completed Results DMC FDA Device

• 1 other identifier: 23-00842
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Corticospinal Tract (CST) Lesion Load

  Baseline

Study Arms (2)

Patients with History of Stroke

EXPERIMENTAL

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; Device: Exoskeleton Device

Healthy Controls

EXPERIMENTAL

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; Device: Exoskeleton Device

Interventions

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.

Healthy Controls; Patients with History of Stroke

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.

Healthy Controls; Patients with History of Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health (222 East 41st Street)

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Heidi Schambra, MD
• Organization: NYU Langone Health

Heidi.Schambra@nyulangone.org

212-598-6000

Study Officials

• Heidi Schambra, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 18, 2023
• Study Start: January 3, 2024
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)