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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Device-assisted therapy
Therapy-based occupational therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Transcranial direct current stimulation

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University
  • Columbia University
  • University of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Device-assisted therapy

Therapy-based occupational therapy

Arm Description

30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation

30 hours of conventional occupational therapy that emphasizes task-oriented training.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity (FM-UE)
Change in arm impairment, measured by FM-UE

Secondary Outcome Measures

Fugl-Meyer Upper Extremity (FM-UE)
Change in arm impairment, measured by FM-UE

Full Information

First Posted
November 8, 2014
Last Updated
August 8, 2018
Sponsor
Johns Hopkins University
Collaborators
Columbia University, University of Zurich, James S McDonnell Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02292251
Brief Title
Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
Acronym
SMARTS2
Official Title
Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Columbia University, University of Zurich, James S McDonnell Foundation

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device-assisted therapy
Arm Type
Active Comparator
Arm Description
30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation
Arm Title
Therapy-based occupational therapy
Arm Type
Active Comparator
Arm Description
30 hours of conventional occupational therapy that emphasizes task-oriented training.
Intervention Type
Behavioral
Intervention Name(s)
Device-assisted therapy
Intervention Type
Behavioral
Intervention Name(s)
Therapy-based occupational therapy
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity (FM-UE)
Description
Change in arm impairment, measured by FM-UE
Time Frame
from baseline to day 3 post-training
Secondary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity (FM-UE)
Description
Change in arm impairment, measured by FM-UE
Time Frame
from baseline to day 90 post-training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age over 21 years Ischemic stroke confirmed by CT or MRI within the previous 6 weeks No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed) Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment. Ability to give informed consent and understand the tasks involved. Exclusion Criteria: Space-occupying hemorrhagic transformation or associated intracranial hemorrhage. Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention. Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration. Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20. 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). Inability to sit in a chair and perform upper limb exercises for one hour at a time. Participation in another upper extremity rehabilitative therapy study during the study period. Terminal illness Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John W. Krakauer, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Zurich
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33745372
Citation
Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortes 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.
Results Reference
derived
PubMed Identifier
33175411
Citation
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(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived

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Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

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