Exoskeletal Support in Stroke

NCT ID: NCT05996198

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2024-04-29

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oculus Rift headset

Intervention Type: 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

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Oculus Rift headset

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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
• Apraxia
• Global inattention
• Legal blindness

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heidi Schambra, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health (222 East 41st Street)

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

23-00842

Identifier Type: -

Identifier Source: org_study_id