Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: Device-assisted therapy; Behavioral: Therapy-based occupational therapy

• Registration Number: NCT02292251
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-08
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-17
• Study Start: 2015-05
• Primary Completion: 2017-11
• Study Completion: 2018-04
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device-assisted therapy	Device-assisted therapy	30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation
Therapy-based occupational therapy	Therapy-based occupational therapy	30 hours of conventional occupational therapy that emphasizes task-oriented training.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Extremity (FM-UE)	from baseline to day 3 post-training	Change in arm impairment, measured by FM-UE

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Extremity (FM-UE)	from baseline to day 90 post-training	Change in arm impairment, measured by FM-UE

Trial Locations

Locations (3)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Columbia University; 🇺🇸 New York, New York, United States

University of Zurich; 🇨🇭 Zurich, Switzerland