Exoskeletal Support in Stroke

NYU Langone Health

Status: Completed

Conditions: Stroke

Treatments: Device: Oculus Rift headset; Device: Exoskeleton Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05996198

23-00842

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

19 participants in 2 patient groups

Patients with History of Stroke

Experimental group

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.

Treatment:

Device: Exoskeleton Device

Device: Oculus Rift headset

Healthy Controls

Experimental group

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.

Treatment:

Device: Exoskeleton Device

Device: Oculus Rift headset