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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02292251
• Collaborator: Columbia University (Other), University of Zurich (Other), James S McDonnell Foundation (Other)
• Enrollment: 32
• Locations: 3
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site: 10.7
• Patients Per Site Per Month: 0.3

Study Details

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	N/A

Study Design

• Study Type: Interventional
• 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 1, 2015
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Apr 1, 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) [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) [from baseline to day 90 post-training]

   Change in arm impairment, measured by FM-UE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21205
2	Columbia University	New York	New York	United States	10032
3	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02292251
• Other Study ID Numbers: IRB00047647
• First Posted: Nov 17, 2014
• Last Update Posted: Aug 10, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Johns Hopkins University: Stroke; Transcranial direct current stimulation
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Aug 10, 2018