NCT03575481

Brief Summary

The investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

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

September 30, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.4 years

First QC Date

June 17, 2018

Last Update Submit

June 28, 2018

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Muscle activity

    The activity levels of electromyographic signal (in millivolts) will be averaged for the duration of the recording.

    30 minutes

  • Muscle fatigue

    Fatigue expressed by calculation of the the difference between the median frequency in the first 5 minutes and last five minutes of a 30 minute session

    30 minutes

Study Arms (1)

Post stroke patients

Diagnostic Test: The RAT and The TST

Interventions

The RAT and The TSTDIAGNOSTIC_TEST

The RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm.

Post stroke patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

stroke survivors

You may qualify if:

  • to 85 year old individuals up to three months following stroke
  • National Institutes of Health Stroke Scale (NIHSS) score 3-15
  • Intact cognitive function
  • mild to moderate weakness of the affected hand
  • normal or corrected eyesight

You may not qualify if:

  • neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function
  • a pace-maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, 91240, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2018

First Posted

July 2, 2018

Study Start

September 30, 2015

Primary Completion

March 1, 2017

Study Completion

March 29, 2017

Last Updated

July 2, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)