NCT02092662

Brief Summary

The purpose of this study is to evaluate by objective measures the improvement in upper extremity functioning, as reflection of motor learning, in stroke patients in the sub acute phase. The investigators hypothesize that the improvements in daily functioning are partially due to compensation strategies and partially due to motor learning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 6, 2015

Completed
Last Updated

August 6, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

March 12, 2014

Results QC Date

May 14, 2015

Last Update Submit

July 7, 2015

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment.

    zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.

    T1 at the beginning of the hospital stay and folloew up at T2 one month later.

  • Muscle Onset Time.

    Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.

    the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1

Secondary Outcomes (5)

  • Muscle Co-activation Index.

    T1 at the beginning of the hospital stay and folloew up at T2 one month later.

  • Handwriting Velocity

    T1 at the beginning of the hospital stay and follow up at T2 one month later.

  • % Maximum Voluntary Contraction.

    The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.

  • Handwriting Pressure.

    T1 at the beginning of the hospital stay and folloew up at T2 one mont...

  • Handwriting Off-paper Time.

    T1 at the beginning of the hospital stay and folloew up at T2 one mont...

Study Arms (2)

Stroke

Stroke patients at the subacute phase

Other: stroke

Healthy controls

healthy age-matched voluntiers

Other: Healthy controls

Interventions

strokeOTHER

task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context

Stroke
Healthy controlsOTHER

no treatment

Healthy controls

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort will be selected from Fliman Rehabilitation Geriatric Center. Healthy subjects, age and gender-matched will be served as a control group.

You may qualify if:

  • diagnosis of cerebral stroke with upper extremity hemiparesis
  • Ability to understand simple orders

You may not qualify if:

  • Other orthopedic pathology
  • Apraxia
  • Bilateral Paresis
  • Other neurologic pathology
  • sensory aphasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fliman Geriatric Rehabilitation Center

Haifa, Israel, 31021, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Sharon Israely
Organization
University of Haifa
sharonis@mh.org.il
972-523-755-091

Study Officials

  • Emanuel Markovich, MD

    Fliman Geriatric Rehabilitation Center

    PRINCIPAL INVESTIGATOR

  • Sharon Israely, MSc.

    University of Haifa

    STUDY DIRECTOR

  • Eli Carmeli, PhD.

    University of Hifa

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 20, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

August 6, 2015

Results First Posted

August 6, 2015

Record last verified: 2015-06

Locations

IL(1)