Exoskeletal Support in Stroke

Not Applicable

Completed

Conditions: Stroke

Interventions: Device: Oculus Rift headset
Device: Exoskeleton Device

Registration Number: NCT05996198

Lead Sponsor: NYU Langone Health

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with History of Stroke	Oculus Rift headset	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.
Patients with History of Stroke	Exoskeleton Device	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 Controls	Oculus Rift headset	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.
Healthy Controls	Exoskeleton Device	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.

Primary Outcome Measures

Name	Time	Method
Muscle Contribution (MC)	Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)	Muscle Contribution (MC) is a measure of the relative muscle activity between the arms during a bimanual reaching task. Muscle activity was measured using electromyography (EMG); the root-mean-square (RMS) of the EMG timeseries signal in the anterior deltoid. MC in the anterior deltoid was calculated as the RMS in the more-impaired anterior deltoid divided by the sum of RMS values in both anterior deltoids, multiplied by 100. For example, an MC (deltoid) value of 50% indicates that the muscle activity in both anterior deltoids was the same while reaching; an MC value less than 50% indicates that reaching occurred with less muscle activity in the more-impaired deltoid compared to the less-impaired deltoid.
Relative Contribution (RC)	End of VR Task (Day 1 - session lasts approx. 2 hours)	Relative Contribution (RC) is a measure of the relative displacement between the hands during a bimanual reaching task. Displacement of both hands was measured using 3D motion capture using the Oculus Rift VR system. RC is calculated as the displacement of the more-impaired hand divided by the sum of displacements of both hands, multiplied by 100.

Secondary Outcome Measures