Polio and Post-polio SyndromeNCT06162104
Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome
An observational study of Polio and Post-polio Syndrome and Fatigue, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Polio and Post-polio Syndrome, Fatigue, Polio
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 19 Dec 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Individuals aged between 18 and 60 with post-polio syndrome. * Healthy volunteers aged between 18 and 60
Who may be able to join
- Individuals aged between 18 and 60 with post-polio syndrome.
- Healthy volunteers aged between 18 and 60
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İstanbul Physical Medicine and Rehabilitation Research and Training Hospital
Istanbul, Bahcelievler, 34147
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
About this study
Official title: Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome: A Controlled Study
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.
Read the detailed description
Our research is designed as a case-control study. 20 patients diagnosed with post-polio syndrome who present to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital clinics and 20 healthy volunteers will be included in the study. The sociodemographic data of patients and volunteers, such as age, gender, height, weight, body mass index, education level, and occupation, will be recorded. The age at which polio was contracted, the time elapsed since polio, and any accompanying illnesses will be documented. Additionally, if patients experience new symptoms such as pain, weakness, or fatigue, the severity of these symptoms will be assessed using the Visual Analog Scale. The frequency of falls and the presence of fractures caused by falls, ambulation method, and devices used will be noted. Muscle weakness in the extremities will be identified by applying the Manual Muscle Test through physical examination. Subsequently, the patient's current symptoms related to depression and anxiety will be evaluated using the Hospital Anxiety and Depression Scale (HADS), fatigue level will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Short Form-36 (SF-36).
- Conditions
- Polio and Post-polio Syndrome, Fatigue, Polio
- Being tested
- No intervention
- Keywords
- Poliomyelitis, Fatigue, Postpoliomyelitis Syndrome
- Medical subject headings
- Postpoliomyelitis Syndrome, Fatigue, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Post-poliomyelitis syndrome group | Patients suffering from post-poliomyelitis syndrome Receives: Other: No intervention | |
| Healthy volunteers | Control gruoup with healthy volunteers Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 day
Secondary outcomes (3)
Short Form-36
This form comprises 36 items that inquire about the quality of life. Lower scores indicate a poorer condition.
Measured: 0 day
Hospital Anxiety and Depression Scale
This scale is a 14-item assessment method, consisting of 7 questions each, designed to inquire about symptoms related to anxiety and depression in patients. As the score increases, the level of anxiety and depression worsens.
Measured: 0 day
Visual Analogue Scale
The Visual Analog Scale is a simple measurement tool consisting of a line with endpoints representing extreme points of a characteristic, such as "No Pain" to "Worst Pain Imaginable." Respondents mark a point on the line to indicate their perception or experience of the given characteristic.
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023
- Primary completion18 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Polio and Post-polio SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162104
- Sponsor's protocol ID
- IstPRMTRH6
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32790481On 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.
PubMed 16931464Bruno 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.
PubMed 9790485
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fatigue Severity, Mood, and Quality of Life in Post-Polio Syndrome: A Controlled Study
- ClinicalTrials.gov ID
- NCT06162104
- Acronym / sponsor ID
- IstPRMTRH6
- Conditions
- Polio and Post-polio Syndrome, Fatigue, Polio
- Keywords
- Poliomyelitis, Fatigue, Postpoliomyelitis Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our research is designed as a case-control study. 20 patients diagnosed with post-polio syndrome who present to the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital clinics and 20 healthy volunteers will be included in the study. The sociodemographic data of patients and volunteers, such as age, gender, height, weight, body mass index, education level, and occupation, will be recorded. The age at which polio was contracted, the time elapsed since polio, and any accompanying illnesses will be documented. Additionally, if patients experience new symptoms such as pain, weakness, or fatigue, the severity of these symptoms will be assessed using the Visual Analog Scale. The frequency of falls and the presence of fractures caused by falls, ambulation method, and devices used will be noted. Muscle weakness in the extremities will be identified by applying the Manual Muscle Test through physical examination. Subsequently, the patient's current symptoms related to depression and anxiety will be evaluated using the Hospital Anxiety and Depression Scale (HADS), fatigue level will be assessed using the Fatigue Severity Scale (FSS), and quality of life will be evaluated using the Short Form-36 (SF-36).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-poliomyelitis syndrome group | – | Other: No interventionPatients suffering from post-poliomyelitis syndrome |
| Healthy volunteers | – | Other: No interventionControl gruoup with healthy volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Individuals aged between 18 and 60 with post-polio syndrome. * Healthy volunteers aged between 18 and 60
Key inclusion criteria (2 listed)
- Individuals aged between 18 and 60 with post-polio syndrome.
- Healthy volunteers aged between 18 and 60
Key exclusion criteria (7 listed)
- fibromyalgia,
- chronic fatigue syndrome,
- presence of chronic decompensated cardiac, renal, and hepatic insufficiency,
- known psychiatric disorders,
- rheumatological diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Healthy volunteers, Post-poliomyelitis syndrome group |
Primary outcome
Fatigue Severity Scale
Time frame: 0 day
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.
3 secondary outcomes
Short Form-36
Time frame: 0 day
Hospital Anxiety and Depression Scale
Time frame: 0 day
Visual Analogue Scale
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 32790481Gusi 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.
- Background: PubMed 16931464On 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.
- Results publication: PubMed 9790485Bruno 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.
- Individual participant dataSharing planned: No
Related trials for Polio and Post-polio Syndrome
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Nomad P-KAFO Study
Cerebrovascular Accident, Post-polio Syndrome
Active, not recruiting
Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis
Spinal Cord Injuries, Poliomyelitis
RecruitingObservational study
Impairments of Neuro-muscular Communication in Motor-Neuron Disease: A Bio-Marker for Early and Personalised Diagnosis
ALS (Amyotrophic Lateral Sclerosis), Postpoliomyelitis Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polio and Post-polio Syndrome and Fatigue, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: 0 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162104, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.