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

Johns Hopkins University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Device-assisted therapy; Behavioral: Therapy-based occupational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02292251

IRB00047647

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Device-assisted therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Device-assisted therapy

Therapy-based occupational therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Therapy-based occupational therapy