3D for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stroke
3D - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a new tool that provides feedback on volitional finger force generation can help restore hand function post stroke.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stroke

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3rd baseline to 1 month post intervention

Month 1
Action Research Arm Test
Box and Block Test
Week 1
Action Research Arm Test (ARAT)
Month 1
Force Direction

Trial Safety

Safety Progress

1 of 3

Other trials for Stroke

Side Effects for

3DRT
65%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%Telangiectasia
15%Burn
15%Lymphedema-related fibrosis
15%Pruritus/itching
12%Dry skin
8%Hot flashes/flushes
8%Mood alteration
8%AST, SGOT(serum glutamic oxaloacetic transaminase)
8%Edema: trunk/genital
8%Pulmonary/Upper Respiratory - Other
8%Muscle weakness, generalized
8%Rash/desquamation
4%Dermatology/Skin - Other
4%Otitis, middle ear (non-infectious)
4%Leukocytes (total WBC)
4%Left ventricular diastolic dysfunction
4%Pain - Other
4%Nausea
4%Hair loss/alopecia (scalp or body)
4%Tremor
4%Anorexia
4%Infection with Grade 3 or 4 neutrophils
4%Glucose, serum-high (hyperglycemia)
4%Gastrointestinal - Other
4%ALT, SGPT (serum glutamic pyruvic transaminase)
4%Cardiac General - Other
4%Fibrosis-deep connective tissue
4%Extremity-lower (gait/walking)
4%Diarrhea
4%Lymphatics - Other
4%Lymphopenia
4%Irregular menses (change from baseline)
4%Musculoskeletal/Soft Tissue - Other
4%Joint-function
4%Vaginal dryness
4%Sodium, serum-low (hyponatremia)
4%Sexual/Reproductive Function - Other
4%Seroma
4%Neuropathy: motor
4%Neuropathy: sensory
This histogram enumerates side effects from a completed 2016 Phase 1 & 2 trial (NCT00581256) in the 3DRT ARM group. Side effects include: Hyperpigmentation with 65%, Rash: dermatitis associated with radiation with 62%, Fatigue (asthenia, lethargy, malaise) with 46%, Edema: limb with 42%, Induration/fibrosis (skin and subcutaneous tissue) with 31%.

Trial Design

2 Treatment Groups

1D
1 of 2
3D
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: 3D · No Placebo Group · N/A

3D
Behavioral
Experimental Group · 1 Intervention: 3D · Intervention Types: Behavioral
1D
Behavioral
ActiveComparator Group · 1 Intervention: 1D · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3D
2013
Completed Phase 2
~160

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3rd baseline to 1 month post intervention

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,472 Previous Clinical Trials
2,741,634 Total Patients Enrolled
78 Trials studying Stroke
3,958 Patients Enrolled for Stroke
Na Jin Seo, PhD MS BSPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Stroke
15 Patients Enrolled for Stroke

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have no limitation in the ability to recognize all quadrants of the visual field.
You have survived a stroke at least 3 months ago.
You have sufficient cognitive ability to participate in the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.