Exoskeletal Support in Stroke

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05996198
Collaborator
(none)
24
1
2
10.3
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Oculus Rift headset
  • Device: Exoskeleton Device
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Pilot Proof of Concept, Single Site Study to Assess the Effect of Exoskeletal Support on Motor Control Strategies in Individuals With Stroke
Anticipated Study Start Date :
Aug 21, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Relative Contribution (RC) Level [Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)]

    Measured via arm trajectory analysis as a percentage (%); evaluates arm control.

  2. Change in Muscle Contribution (MC) Level [Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)]

    Measured via electromyographical analysis as a percentage (%); evaluates arm control.

Secondary Outcome Measures

  1. Corticospinal Tract (CST) Lesion Load [Baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health (222 East 41st Street) New York New York United States 10017

Sponsors and Collaborators

  • NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05996198
Other Study ID Numbers:
  • 23-00842
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 18, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2023