Your session is about to expire
← Back to Search
Feedback Training for Hand Function After Stroke (NEAD Trial)
N/A
Waitlist Available
Led By Na Jin Seo, PhD MS BS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ability to generate palpable volitional grip force upon cue
Sufficient cognitive ability to participate (NIH Stroke Scale, NIHSS, Questions and Commands score = 0-1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3rd baseline to 1 month post intervention
Awards & highlights
NEAD Trial Summary
This trial will test if a new tool that provides feedback on volitional finger force generation can help restore hand function post stroke.
Who is the study for?
This trial is for stroke survivors with moderate to severe hand impairment who can grip and follow simple instructions. They should be at least 3 months post-stroke, have some cognitive ability, and no visual field loss. Excluded are those in other upper limb rehab, with severe muscle tone issues or total sensory loss in fingertips, recent spasticity treatment changes, or certain comorbidities.Check my eligibility
What is being tested?
The study tests a new tool that gives feedback on finger force direction during exercises (1D vs. 3D training) to see if it helps restore hand function after a stroke. Participants will use this tool to practice generating forces with their fingers in different directions.See study design
What are the potential side effects?
Since the intervention involves physical therapy tools rather than medication, typical side effects related to drugs are not expected. However, participants may experience fatigue or discomfort from the exercises.
NEAD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You can squeeze an object when asked to do so.
Select...
You need to be able to understand and follow simple instructions.
NEAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3rd baseline to 1 month post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3rd baseline to 1 month post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Action Research Arm Test (ARAT)
Other outcome measures
Action Research Arm Test
Box and Block Test
Force Direction
Side effects data
From 2016 Phase 1 & 2 trial • 54 Patients • NCT0058125665%
Hyperpigmentation
62%
Rash: dermatitis associated with radiation
46%
Fatigue (asthenia, lethargy, malaise)
42%
Edema: limb
31%
Induration/fibrosis (skin and subcutaneous tissue)
27%
Pain
27%
Breast volume/hypoplasia
19%
Breast nipple/areolar deformity
15%
Lymphedema-related fibrosis
15%
Telangiectasia
15%
Burn
15%
Pruritus/itching
12%
Dry skin
8%
Mood alteration
8%
Pulmonary/Upper Respiratory - Other
8%
Rash/desquamation
8%
AST, SGOT(serum glutamic oxaloacetic transaminase)
8%
Hot flashes/flushes
8%
Muscle weakness, generalized
8%
Edema: trunk/genital
4%
Neuropathy: motor
4%
Leukocytes (total WBC)
4%
Lymphopenia
4%
Otitis, middle ear (non-infectious)
4%
Cardiac General - Other
4%
Vaginal dryness
4%
Nausea
4%
Diarrhea
4%
Pain - Other
4%
Sodium, serum-low (hyponatremia)
4%
Tremor
4%
Anorexia
4%
Dermatology/Skin - Other
4%
Neuropathy: sensory
4%
Extremity-lower (gait/walking)
4%
Glucose, serum-high (hyperglycemia)
4%
Hair loss/alopecia (scalp or body)
4%
Infection with Grade 3 or 4 neutrophils
4%
Left ventricular diastolic dysfunction
4%
Musculoskeletal/Soft Tissue - Other
4%
Gastrointestinal - Other
4%
ALT, SGPT (serum glutamic pyruvic transaminase)
4%
Fibrosis-deep connective tissue
4%
Lymphatics - Other
4%
Irregular menses (change from baseline)
4%
Joint-function
4%
Sexual/Reproductive Function - Other
4%
Seroma
100%
80%
60%
40%
20%
0%
Study treatment Arm
3DRT
IMRT
NEAD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 3DExperimental Treatment1 Intervention
The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen.
Group II: 1DActive Control1 Intervention
The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3D
2013
Completed Phase 2
~210
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,608 Previous Clinical Trials
3,306,192 Total Patients Enrolled
83 Trials studying Stroke
6,667 Patients Enrolled for Stroke
Na Jin Seo, PhD MS BSPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
2 Previous Clinical Trials
77 Total Patients Enrolled
2 Trials studying Stroke
77 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently undergoing therapy for your upper limbs.You have difficulty understanding and following simple instructions.You have very tight muscles that make it hard for you to move your fingers or place them correctly for the training.You had a stroke at least 3 months ago.You can squeeze an object when asked to do so.You need to be able to understand and follow simple instructions.You have complete loss of feeling in your fingertips.You have other health conditions that could limit your movement or affect your nerves.You have changed your spasticity medication or had a botulinum toxin injection in your arm within the past 3 months or during the study.You have moderate to severe hand impairment.You can see well in all areas of your field of vision.
Research Study Groups:
This trial has the following groups:- Group 1: 3D
- Group 2: 1D
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.
How many people are currently engaged in this research?
"Yes, according to information on clinicaltrials.gov, this medical trial is actively recruiting patients and began accepting applications as of October 28th 2020. The data was last updated on February 15th 2022 and the team needs roughly 60 volunteers from a single site."
Answered by AI
Are there currently vacancies for this research endeavor?
"Affirmative, the clinicaltrials.gov page has evidence that this trial is currently in need of volunteers. Originally posted on October 28th 2020 and updated February 15 2022, 60 individuals are needed for this single-site research project."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger