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Exoskeletal Support in Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculus Rift headset
Exoskeleton Device
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • NYU Langone Health (222 East 41st Street)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with History of Stroke

Healthy Controls

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Relative Contribution (RC) Level
Measured via arm trajectory analysis as a percentage (%); evaluates arm control.
Change in Muscle Contribution (MC) Level
Measured via electromyographical analysis as a percentage (%); evaluates arm control.

Secondary Outcome Measures

Corticospinal Tract (CST) Lesion Load
Measured via MRI; lesion load is expressed as percentage of the entire CST.

Full Information

First Posted
August 9, 2023
Last Updated
August 9, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05996198
Brief Title
Exoskeletal Support in Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 21, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with History of Stroke
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Oculus Rift headset
Intervention Description
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
Intervention Name(s)
Exoskeleton Device
Intervention Description
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 Outcome Measure Information:
Title
Change in Relative Contribution (RC) Level
Description
Measured via arm trajectory analysis as a percentage (%); evaluates arm control.
Time Frame
Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
Title
Change in Muscle Contribution (MC) Level
Description
Measured via electromyographical analysis as a percentage (%); evaluates arm control.
Time Frame
Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
Secondary Outcome Measure Information:
Title
Corticospinal Tract (CST) Lesion Load
Description
Measured via MRI; lesion load is expressed as percentage of the entire CST.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Brunfeldt, PhD
Phone
929-455-5517
Email
alexander.brunfeldt@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Schambra, MD
Phone
212-598-6000
Email
Heidi.Schambra@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Schambra, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health (222 East 41st Street)
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Exoskeletal Support in Stroke

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