Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Stroke Clinical Trial

— SMARTS2  

Official title:

Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02292251
• Other study ID #: IRB00047647
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: April 2018

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Device-assisted therapy

• Therapy-based occupational therapy

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich
United States	Johns Hopkins University	Baltimore	Maryland
United States	Columbia University	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Columbia University, James S McDonnell Foundation, University of Zurich

Countries where clinical trial is conducted

United States,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Upper Extremity (FM-UE)	Change in arm impairment, measured by FM-UE	from baseline to day 3 post-training
Secondary	Fugl-Meyer Upper Extremity (FM-UE)	Change in arm impairment, measured by FM-UE	from baseline to day 90 post-training