NCT06162104

Brief Summary

The aim of this study is to investigate the differences in the severity of fatigue, impact on quality of life, and mood between individuals with post-polio syndrome and healthy volunteer groups. Additionally, the interrelationships of these parameters within the post-polio syndrome patient group will be examined. The goal is to raise awareness during the follow-up process for individuals with post-polio syndrome by questioning fatigue and mood symptoms, and to facilitate the implementation of necessary precautions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2023

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

17 days

First QC Date

November 30, 2023

Last Update Submit

February 18, 2024

Conditions

Polio and Post-polio SyndromeFatiguePolio

Keywords

PoliomyelitisFatiguePostpoliomyelitis Syndrome

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity Scale

    This scale consists of 9 items assessing the severity of fatigue and its impact on individuals. Each item is scored on a scale ranging from 0 to 7.

    0 day

Secondary Outcomes (3)

  • Short Form-36

    0 day

  • Hospital Anxiety and Depression Scale

    0 day

  • Visual Analogue Scale

    0 day

Study Arms (2)

Post-poliomyelitis syndrome group

Patients suffering from post-poliomyelitis syndrome

Other: No intervention

Healthy volunteers

Control gruoup with healthy volunteers

Other: No intervention

Interventions

No interventionOTHER

No intervention

Healthy volunteersPost-poliomyelitis syndrome group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

* Individuals aged between 18 and 60 with post-polio syndrome. * Healthy volunteers aged between 18 and 60

You may qualify if:

  • Individuals aged between 18 and 60 with post-polio syndrome.
  • Healthy volunteers aged between 18 and 60

You may not qualify if:

  • fibromyalgia,
  • chronic fatigue syndrome,
  • presence of chronic decompensated cardiac, renal, and hepatic insufficiency,
  • known psychiatric disorders,
  • rheumatological diseases,
  • presence of other known neurological diseases,
  • use of medications aimed at improving physical performance or alleviating fatigue.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

İstanbul Physical Medicine and Rehabilitation Research and Training Hospital

Istanbul, Bahcelievler, 34147, Turkey (Türkiye)

Location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location

Related Publications (3)

  • Gusi N, Madruga M, Gonzalez-Gonzalez MLA, Perez-Gomez J, Prieto-Prieto J. Health-related quality of life and multidimensional fitness profile in polio survivors. Disabil Rehabil. 2022 Apr;44(8):1374-1379. doi: 10.1080/09638288.2020.1804629. Epub 2020 Aug 13.

    PMID: 32790481BACKGROUND

  • On AY, Oncu J, Atamaz F, Durmaz B. Impact of post-polio-related fatigue on quality of life. J Rehabil Med. 2006 Sep;38(5):329-32. doi: 10.1080/16501970600722395.

    PMID: 16931464BACKGROUND

  • Bruno RL, Creange SJ, Frick NM. Parallels between post-polio fatigue and chronic fatigue syndrome: a common pathophysiology? Am J Med. 1998 Sep 28;105(3A):66S-73S. doi: 10.1016/s0002-9343(98)00161-2.

    PMID: 9790485RESULT

MeSH Terms

Conditions

Postpoliomyelitis SyndromeFatiguePoliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

December 1, 2023

Primary Completion

December 18, 2023

Study Completion

December 19, 2023

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)