Stroke
Conditions
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.
Interventions
DEVICEOculus 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.
DEVICEExoskeleton 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.
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corticospinal Tract (CST) Lesion Load | Baseline | Measured via MRI; lesion load is expressed as percentage of the entire CST. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 8 |
| 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.
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. | 10 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Patients With History of Stroke | Total | Healthy Controls |
|---|---|---|---|
| Age, Continuous | 59.75 years STANDARD_DEVIATION 8.46 | 60.77 years STANDARD_DEVIATION 10.01 | 61.6 years STANDARD_DEVIATION 11.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 18 Participants | 10 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 8 participants | 18 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 10 |
| other Total, other adverse events | 0 / 9 | 0 / 10 |
| serious Total, serious adverse events | 0 / 9 | 0 / 10 |
Outcome results
Primary
Muscle Contribution (MC)
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.
Time frame: Baseline, End of VR Task (Day 1 - session lasts approx. 2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With History of Stroke | Muscle Contribution (MC) | -0.68 Percent | Standard Deviation 2.86 |
| Healthy Controls | Muscle Contribution (MC) | -4.35 Percent | Standard Deviation 11.58 |
Primary
Relative Contribution (RC)
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.
Time frame: End of VR Task (Day 1 - session lasts approx. 2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With History of Stroke | Relative Contribution (RC) | -0.74 percent | Standard Deviation 1.94 |
| Healthy Controls | Relative Contribution (RC) | -0.25 percent | Standard Deviation 1.65 |
Secondary
Corticospinal Tract (CST) Lesion Load
Measured via MRI; lesion load is expressed as percentage of the entire CST.
Time frame: Baseline
Population: Outcome Measure was not assessed for the Healthy Control Arm/Group as the healthy controls do not have lesioned brain tissue.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With History of Stroke | Corticospinal Tract (CST) Lesion Load | 5.71 Percentage of the entire CST | Standard Deviation 6.6 |