Skip to main content
OpenTrials
Completed

NCT Number: NCT02292251

Study to Enhance Motor Acute Recovery With Intensive Training After Stroke

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich, Zurich, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 21 years
  • Ischemic stroke confirmed by CT or MRI within the previous 6 weeks
  • No history of prior ischemic or hemorrhagic stroke with associated motor deficits (prior stroke with no motor symptoms is allowed)
  • Residual unilateral arm weakness with Fugl-Meyer Upper Extremity (FM-UE) score 6-40 at time of enrollment.
  • Ability to give informed consent and understand the tasks involved.

Exclusion criteria

  • Space-occupying hemorrhagic transformation or associated intracranial hemorrhage.
  • Arm impairment that is too severe or too mild on day of baseline testing just prior to beginning of the study intervention.
  • Recent botox injection to upper limb or planned botox injection over the course of the 7-month study duration.
  • Cognitive impairment, with score on Montreal Cognitive Assessment (MoCA) ≤ 20.
  • 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).
  • Inability to sit in a chair and perform upper limb exercises for one hour at a time.
  • Participation in another upper extremity rehabilitative therapy study during the study period.
  • Terminal illness
  • Social and/or personal circumstances that interfere with ability to return for therapy sessions and follow up assessments.

Treatment and study plan

Device-assisted therapy

Behavioral

Therapy-based occupational therapy

Behavioral

Primary outcomes

  1. Fugl-Meyer Upper Extremity (FM-UE)

    Time frame: from baseline to day 3 post-training

    Change in arm impairment, measured by FM-UE

Secondary outcomes

  1. Fugl-Meyer Upper Extremity (FM-UE)

    Time frame: from baseline to day 90 post-training

    Change in arm impairment, measured by FM-UE

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Columbia University
  • James S McDonnell Foundation
  • University of Zurich

Registry information

Acronym: SMARTS2

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Nov 17, 2014
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.