Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02292251
• Date of registration: 08/11/2014
• Prospective Registration: Yes
• Primary sponsor: Johns Hopkins University
• Public title: Study to Enhance Motor Acute Recovery With Intensive Training After Stroke SMARTS2
• Scientific title: Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
• Date of first enrolment: May 2015
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02292251
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland, United States

Contacts

• Name: John W. Krakauer, MD
• Affiliation: Johns Hopkins University

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Behavioral: Device-assisted therapy

Behavioral: Therapy-based occupational therapy

Primary Outcome(s)

Fugl-Meyer Upper Extremity (FM-UE) [Time Frame: from baseline to day 3 post-training]

Secondary Outcome(s)

Fugl-Meyer Upper Extremity (FM-UE) [Time Frame: from baseline to day 90 post-training]

Secondary ID(s)

IRB00047647

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Zurich

Columbia University

James S McDonnell Foundation