Exoskeletal Support in Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996198
• Other study ID #: 23-00842
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Alexander Brunfeldt, PhD
• Phone: 929-455-5517
• Email: alexander.brunfeldt[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health (222 East 41st Street)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Relative Contribution (RC) Level	Measured via arm trajectory analysis as a percentage (%); evaluates arm control.	Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
Primary	Change in Muscle Contribution (MC) Level	Measured via electromyographical analysis as a percentage (%); evaluates arm control.	Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
Secondary	Corticospinal Tract (CST) Lesion Load	Measured via MRI; lesion load is expressed as percentage of the entire CST.	Baseline