Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Device-assisted therapy

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

Group Type ACTIVE_COMPARATOR

Device-assisted therapy

Intervention Type BEHAVIORAL

Therapy-based occupational therapy

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

Group Type ACTIVE_COMPARATOR

Therapy-based occupational therapy

Intervention Type BEHAVIORAL

Interventions

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Device-assisted therapy

Intervention Type BEHAVIORAL

Therapy-based occupational therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No