An interventional study of Early Intensive upper extremity motor training and Sub-acute intensive upper extremity motor training in Stroke, Brain Infarction and Brain Ischemia, sponsored by MedStar National Rehabilitation Network. Status unknown at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-07.
Sponsored by MedStar National Rehabilitation Network · Not applicable, Interventional, and Treatment
To perform an exploratory single center randomized study that will form the basis for a larger scale, more definitive randomized clinical trial to determine the optimal time after stroke for intensive motor training. The investigators will perform a prospective exploratory study of upper extremity (UE) motor training delivered at higher than usual intensity at three different time points after stroke:
The control group will not receive the therapy intervention during the 1-year study.
Outcome measures will be assessed at baseline, pre-treatment, post-treatment, 6 months and one year after stroke onset.
Compared to individuals randomized during the outpatient (2-3 months after stroke onset) or chronic (6-9 months after stroke onset) time points, participants randomized to early intensive motor training will show greater upper extremity motor improvement measured at one year post stroke.
Please see the following reference:
Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan, E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M., Fiandaca, M.S., Federoff, H.J., \& Newport, E.L. (2015). Critical Periods after Stroke Study: Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human Neuroscience, 9, 002231. PMCID: PMC4413691.
219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 139 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →MedStar National Rehabilitation Network is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Compared within Cerebral Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Recovering moderate motor impairment at the shoulder and elbow or hand such as:
or
or
Active range of motion (AROM) to at least 50% of range in gravity eliminated position for shoulder flexion or abduction, and for any of the following motions: elbow flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger extension.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention: A 20-hour dose of early intensive upper extremity motor training therapy will be initiated within 30 days post-stroke.
Behavioral: Early Intensive upper extremity motor training
Intervention: A 20-hour dose of sub-acute intensive upper extremity motor training therapy will be initiated within 2 to 3 months post-stroke.
Behavioral: Sub-acute intensive upper extremity motor training
Intervention: A 20-hour dose of chronic intensive upper extremity motor training therapy will be initiated 6 to 9 months post-stroke
Behavioral: Chronic intensive upper extremity motor training
Intervention: Usual and customary care. No additional therapy will be initiated during the 1-year study.
Behavioral: Control
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset.
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke.
Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke.
Usual and Customary Care only. No additional therapy will be given during the 1-year study.
Action Research Arm Test (ARAT)
The ARAT assesses functional limitations and evaluates changes in limb function for the upper extremity.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Motor Activity Log - 28 Quality of Movement (MAL-28 QOM)
A structured interview to measure upper extremity use and function as well as assess the quality of movement of the hemiparetic arm.
Time frame: Pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Nine Hole Peg Test (9-HPT)
A standardized quantitative test of upper extremity function and fine manual dexterity.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Functional Independence Measure (FIM)
A basic indicator of severity of disability. Tracks changes in the functional ability of the patient during an episode of hospital rehabilitation care.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Barthel Index (BI)
Measures performance in activities of daily living and functional disability.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Motricity Index - Arm only (MI)
To assess motor impairment and strength in the upper extremity.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Perception of change (POC)
A stroke-specific self-report to assess how stroke has impacted a person's life and their overall perception of recovery.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Stroke Impact Scale - Hand-Arm subscale (SIS)
A self-report health status measure to assess perceived recovery with regard to the more affected hand and arm following a stroke.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Modified Rankin Scale (MRS)
A measure of the degree of disability or dependence in daily activities following a stroke.
Time frame: Baseline (pre-stroke assessment), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended) and 1 year post stroke
Activity Card Sort (ACS)
An interview-based assessment used to measure an individual's participation in instrumental, leisure and social activities.
Time frame: Pre-treatment (ideally within 72 hours of baseline), post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Reintegration to Normal Living Index (RNLI)
To assess quantitatively the degree that individuals who have experienced a traumatic injury or illness come to manage and reintegrate normal social activities with regard to recreation, movement at home and within the community, family and relationships.
Time frame: Post-treatment (within 72 hours after treatment has ended), 6 months and 1 year post stroke
Geriatric Depression Scale (GDS-15)
A self-report assessment used to identify depressive symptoms in the elderly.
Time frame: Baseline (within 30 days post stroke), pre-treatment, and 1 year post stroke
NIH Stroke Scale (NIHSS)
A systematic assessment used to evaluate and measure stroke-related. neurological impairments and stroke severity.
Time frame: Baseline (within 30 days post stroke), pre-treatment, 6 months and 1 year post stroke
Short Blessed Orientation and Memory Concentration Test (SBT)
An assessment of cognitive ability and impairment.
Time frame: Baseline (within 30 days post stroke)
Mesulam Symbol Cancellation Test (SCT)
An assessment used to evaluate visuospatial function and attention.
Time frame: Baseline (within 30 days post stroke)
Faces Pain Scale
A self-report measure of pain intensity.
Time frame: Baseline (within 30 days post stroke), pre-treatment, post-treatment (ideally within 72 hours after treatment has ended), 6 months and 1 year post stroke
Fugl Meyer Assessment (Upper Extremity)
A performanced-based impairment index to assess motor function, sensation and joint function.
Time frame: Baseline (within 30 days post stroke) and 1 year post stroke
Manual Muscle Test (Upper Extremity)
Muscle strength assessment
Time frame: Baseline (within 30 days post stroke)
Motor Assessment Scale - Upper Arm Function (MAS)
Performance-based scale to assess everyday motor function.
Time frame: Baseline (within 30 days of stroke onset)
Plan to share: No — There is no plan at this time to make individual participant data available.
Started Aug 2014 (actual). Primary completion is estimated for Dec 2020, 76 months after the start.
Of 27 interventional studies with no phase under Cerebral Infarction, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 49. This study's planned 76 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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MedStar National Rehabilitation Network