Study to Enhance Motor Acute Recovery With Intensive Training After Stroke (SMARTS2)

• ClinicalTrials.gov Identifier: NCT02292251
• Recruitment Status: Completed
• First Posted: November 17, 2014
• Last Update Posted: August 10, 2018
• Sponsor: Johns Hopkins University
• Collaborators: Columbia University; University of Zurich; James S McDonnell Foundation
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.

Condition or disease	Intervention/treatment	Phase
Stroke	Behavioral: Device-assisted therapy; Behavioral: Therapy-based occupational therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
• Actual Study Start Date: May 2015
• Actual Primary Completion Date: November 2017
• Actual Study Completion Date: April 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Device-assisted therapy; 30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation	Behavioral: Device-assisted therapy
Active Comparator: Therapy-based occupational therapy; 30 hours of conventional occupational therapy that emphasizes task-oriented training.	Behavioral: Therapy-based occupational therapy

Outcome Measures

Primary Outcome Measures :

1. Fugl-Meyer Upper Extremity (FM-UE) [ Time Frame: from baseline to day 3 post-training ]
   Change in arm impairment, measured by FM-UE

Secondary Outcome Measures :

1. Fugl-Meyer Upper Extremity (FM-UE) [ Time Frame: from baseline to day 90 post-training ]
   Change in arm impairment, measured by FM-UE

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age over 21 years
2. Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
3. No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
4. Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
5. Ability to give informed consent and understand the tasks involved.

Exclusion Criteria:

1. Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
2. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
3. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
4. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
5. History of physical or neurological condition that interferes with study procedures or assessment of motor function (e.g. severe arthritis, severe neuropathy, Parkinson's disease).
6. Inability to sit in a chair and perform upper limb exercises for one hour at a time.
7. Participation in another upper extremity rehabilitative therapy study during the study period.
8. Terminal illness
9. Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205

United States, New York

Columbia University

New York, New York, United States, 10032

Switzerland

University of Zurich

Zurich, Switzerland

Sponsors and Collaborators

Johns Hopkins University

Columbia University

University of Zurich

James S McDonnell Foundation

Investigators

• Principal Investigator: John W. Krakauer, MD; Johns Hopkins University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortés JC, Forrence A, Xu J, DeLuzio S, Held JP, Schwarz A, Steiner L, Widmer M, Jordan K, Ludwig D, Moore M, Barbera M, Vora I, Stockley R, Celnik P, Zeiler S, Branscheidt M, Kwakkel G, Luft AR. Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Neurorehabil Neural Repair. 2021 May;35(5):393-405. doi: 10.1177/15459683211000730. Epub 2021 Mar 20.

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11:CD009645. doi: 10.1002/14651858.CD009645.pub4.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02292251
• Other Study ID Numbers: IRB00047647
• First Posted: November 17, 2014
• Last Update Posted: August 10, 2018
• Last Verified: August 2018

Keywords provided by Johns Hopkins University:

Stroke; Transcranial direct current stimulation

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases