- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04670315
Validation of the Telematic Version of the Fugl-Meyer Scale
November 20, 2023 updated by: Rocío Llamas-Ramos, University of Salamanca
Validation of theTelematic Spanish Version of the Fugl-Meyer Assessment of Motor Recovery After Stroke
Stroke is one of the most prevalent pathologies worldwide and its consequences require long-term treatment.
The current situation caused by the Sars-cov-2 virus has collapsed health systems and has delayed these patient's treatment.
The proposed alternative is telerehabilitation: a treatment system that has already proved its effectiveness.
However, the difficulty to assess the stroke patient's functional status is the great problem.
For this reason, a Fugl Meyer Assessment Scale adaptation, one of the most widely used (in research and in clinic), is proposed to be carried out remotely.
The objective of our study is to validate this scale in stroke patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Salamanca, Spain, 37007
- Universidad de Salamanca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients older than 18 years with a diagnosis of stroke
Description
Inclusion Criteria:
- Being older than 18-years-old
- Diagnosis of stroke
Exclusion Criteria:
- Another neurological or orthopedic problem different than stroke that will affect functionality and balance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single Group
Scale validation in stroke patients
|
Validation of the Telematic Spanish Version of the Fugl Meyer Assessment Scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fugl Meyer Assessment of sensorimotor function
Time Frame: baseline
|
baseline
|
|
Fugl-Meyer Assessment Upper Extremity (FMA-UE)
Time Frame: Baseline
|
Baseline
|
|
Fugl-Meyer Assessment Lower Extremity (FMA-LE)
Time Frame: Baseline
|
Baseline
|
|
Fugl Meyer Assessment of sensorimotor function (Short Form)
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2022
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
December 9, 2020
First Submitted That Met QC Criteria
December 15, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Estimated)
November 22, 2023
Last Update Submitted That Met QC Criteria
November 20, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUROUSAL03/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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