Validation of the Telematic Version of the Fugl-Meyer Scale

NCT04670315 | Completed

• 1 other identifier: NEUROUSAL03/2020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Stroke; Validation Study; Patient Outcome Assessment

Outcome Measures

Primary Outcomes (4)

• Fugl Meyer Assessment of sensorimotor function

  baseline

• Fugl-Meyer Assessment Upper Extremity (FMA-UE)

  Baseline

• Fugl-Meyer Assessment Lower Extremity (FMA-LE)

  Baseline

• Fugl Meyer Assessment of sensorimotor function (Short Form)

  Baseline

Study Arms (1)

Single Group

Scale validation in stroke patients

Diagnostic Test: Telematic evaluation of motor function

Interventions

Telematic evaluation of motor function DIAGNOSTIC_TEST

Validation of the Telematic Spanish Version of the Fugl Meyer Assessment Scale

Single Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 years with a diagnosis of stroke

You may qualify if:

• Being older than 18-years-old
• Diagnosis of stroke

You may not qualify if:

• Another neurological or orthopedic problem different than stroke that will affect functionality and balance

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Universidad de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 17, 2020
• Study Start: June 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

ES (1)