NCT Number: NCT02292251
Study to Enhance Motor Acute Recovery With Intensive Training After Stroke
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.
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Notify MeKey information
Conditions
Age range
21 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Zurich, Zurich, Switzerland
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Therapy-based occupational therapy
BehavioralPrimary outcomes
-
Fugl-Meyer Upper Extremity (FM-UE)
Time frame: from baseline to day 3 post-training
Change in arm impairment, measured by FM-UE
Secondary outcomes
-
Fugl-Meyer Upper Extremity (FM-UE)
Time frame: from baseline to day 90 post-training
Change in arm impairment, measured by FM-UE
Sponsors and collaborators
Lead sponsor
Johns Hopkins University
Other
Collaborators
- Columbia University
- James S McDonnell Foundation
- University of Zurich
Registry information
Acronym: SMARTS2
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Nov 17, 2014
- Registry last updated
- Aug 10, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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