NCT02292251

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2015

Typical duration for not_applicable stroke

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2.5 years

First QC Date

November 8, 2014

Last Update Submit

August 8, 2018

Conditions

Stroke

Keywords

StrokeTranscranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Upper Extremity (FM-UE)

    Change in arm impairment, measured by FM-UE

    from baseline to day 3 post-training

Secondary Outcomes (1)

  • Fugl-Meyer Upper Extremity (FM-UE)

    from baseline to day 90 post-training

Study Arms (2)

Device-assisted therapy

ACTIVE COMPARATOR

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

Behavioral: Device-assisted therapy

Therapy-based occupational therapy

ACTIVE COMPARATOR

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

Behavioral: Therapy-based occupational therapy

Interventions

Device-assisted therapyBEHAVIORAL
Device-assisted therapy
Therapy-based occupational therapyBEHAVIORAL
Therapy-based occupational therapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Columbia University

New York, New York, 10032, United States

Location

University of Zurich

Zurich, Switzerland

Location

Related Publications (2)

  • Krakauer JW, Kitago T, Goldsmith J, Ahmad O, Roy P, Stein J, Bishop L, Casey K, Valladares B, Harran MD, Cortes JC, Forrence A, Xu J, DeLuzio S, Held JP, Schwarz A, Steiner L, Widmer M, Jordan K, Ludwig D, Moore M, Barbera M, Vora I, Stockley R, Celnik P, Zeiler S, Branscheidt M, Kwakkel G, Luft AR. Comparing a Novel Neuroanimation Experience to Conventional Therapy for High-Dose Intensive Upper-Limb Training in Subacute Stroke: The SMARTS2 Randomized Trial. Neurorehabil Neural Repair. 2021 May;35(5):393-405. doi: 10.1177/15459683211000730. Epub 2021 Mar 20.

    PMID: 33745372DERIVED

  • Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

    PMID: 33175411DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • John W. Krakauer, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2014

First Posted

November 17, 2014

Study Start

May 1, 2015

Primary Completion

November 1, 2017

Study Completion

April 1, 2018

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(2)CH(1)