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Behavioural Intervention
Exoskeletal Support for Stroke
N/A
Recruiting
Led By Heidi Schambra, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy controls: Neurologically healthy (i.e., no history of traumatic brain injury, peripheral neuropathy, seizures, etc.)
Survivors of stroke: have the ability to reach, unsupported, to approximately 70% of arm length
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of vr task (day 1 - session lasts approx. 2 hours)
Awards & highlights
Study Summary
This trial will measure motor performance of stroke patients and healthy controls, with data collected over 2 hours and MRI scans of stroke patients.
Who is the study for?
This trial is for adults who've had a stroke at least six months ago and can reach out their arm to about 70% of its length. It's also for right-handed, neurologically healthy adults over 18. People with conditions affecting VR headset use, upper body injuries, non-stroke neurological issues, severe joint pain, visuospatial neglect, apraxia or blindness cannot join.Check my eligibility
What is being tested?
The study tests how an exoskeleton device and Oculus Rift headset affect motor skills in stroke survivors compared to healthy individuals. Participants will undergo a single session lasting two hours where movement and muscle activity are analyzed.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the exoskeleton or VR headset and fatigue from the physical tasks during the session.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no history of brain or nerve disorders.
Select...
I can reach out with my arm to about 70% of its full length without support.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Muscle Contribution (MC) Level
Change in Relative Contribution (RC) Level
Secondary outcome measures
Corticospinal Tract (CST) Lesion Load
Trial Design
2Treatment groups
Experimental Treatment
Group I: Patients with History of StrokeExperimental Treatment2 Interventions
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.
Group II: Healthy ControlsExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,574 Total Patients Enrolled
19 Trials studying Stroke
2,172 Patients Enrolled for Stroke
Heidi Schambra, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
70 Total Patients Enrolled
1 Trials studying Stroke
70 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have injuries to my arms or hands.I am legally blind.I have difficulty noticing things on one side of my body or space.I am 18 years old or older.I have no history of brain or nerve disorders.I experience severe pain in my arm joints that could interfere with following treatment plans.I can reach out with my arm to about 70% of its full length without support.I have a neurological injury that is not a stroke.Participants with apraxia are not eligible.I am a stroke survivor and I am 18 years old or older.I had a stroke more than six months ago.Everyone: Difficulty paying attention to things around you.People who are very right-handed based on a test that measures hand dominance are needed for this study. This is because the study is looking at differences in arm control between left- and right-handed individuals.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with History of Stroke
- Group 2: Healthy Controls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any slots still available for participants in this research project?
"According to clinicaltrials.gov, this particular trial is not presently taking on any applicants; the listing was initially shared on August 21st 2023 and modified as recently as August 9th 2023. Although no longer enrolling patients, there are 1101 alternative trials actively looking for participants right now."
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