Validation of the Telematic Version of the Fugl-Meyer Scale | NCT04670315

Studies
Validation of the Telematic Version of the Fugl-Meyer Scale

NCT04670315

Sponsor

University of Salamanca

Status

Completed

Last Update Posted

Nov 22, 2023Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Stroke

Interventions

Telematic evaluation of motor function

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Dec 9, 2020

First Submission Date that Met QC Criteria

Dec 15, 2020

First Posted Date

Dec 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Group		Scale validation in stroke patients	Diagnostic Test: Telematic evaluation of motor function

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telematic evaluation of motor function	Diagnostic Test	Validation of the Telematic Spanish Version of the Fugl Meyer Assessment Scale	Single Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients older than 18 years with a diagnosis of stroke

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Salamanca		Salamanca		37007	Spain

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided