PoliomyelitisNCT05303545
Physical Activity in People With Sequelae of Poliomyelitis
An observational study of Poliomyelitis, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
Trial summary
People with disabilities are less physically active than the general population. At present, the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poliomyelitis
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with poliomyelitis sequelae.
Who may be able to join
- Consulting to the Physical Medicine and Rehabilitation Department of our university hospital
- Having poliomyelitis sequelae
- No opposition to be enrolled in the study from the patient
- Affiliation to a social security scheme
Who cannot join
- Disability that does not allow the completion of questionnaires
- Acute intercurrent medical situation
- Use of electric wheelchair
- Under court protection.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Garches, 92380
Vincent T. Carpentier
François Genêt
About this study
Official title: Physical Activity in People With Sequelae of Poliomyelitis : a Cross-sectional Study
People with disabilities are less physically active than the general population. At present, the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity are unknown.
The aim of this study is to describe the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity.
Read the detailed description
This is a cross-sectional, monocentric, cohort study of subjects with poliomyelitis sequelae followed in a Physical Medicine and Rehabilitation Department.
All consecutive eligible outpatient subjects consulting to the Physical Medicine and Rehabilitation Department of our university hospital will be included.
Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.
It is an ancillary study to the NO-AGING study.
- Conditions
- Poliomyelitis
- Being tested
- standard of care for patients with poliomyelitis sequelae
- Keywords
- Exercise, Disabled persons, Rehabilitation, Cross sectional studies, Social inclusion
- Medical subject headings
- Poliomyelitis, Motor Activity, Social Inclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care for patients with poliomyelitis sequelaeOther
clinical examination, radiological, biological and physiological examinations.
| Study group | Role | What they receive |
|---|---|---|
| All subjects with poliomyelitis sequelae | Not described Receives: Other: standard of care for patients with poliomyelitis sequelae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) Questionnaire
Measured: Baseline
Secondary outcomes (1)
Barriers of physical activity
Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 May 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Sante Parasport Connecte Synergies
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- François Genêt, MD-PhD, Principal investigator, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, FranceVincent T Carpentier, MD-MSc, Study chair, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303545
- Sponsor's protocol ID
- 2022-003
- Status last verified
- Jan 2023
- First submitted
- 15 Mar 2022
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in People With Sequelae of Poliomyelitis : a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05303545
- Acronym / sponsor ID
- 2022-003
- Conditions
- Poliomyelitis
- Keywords
- Exercise, Disabled persons, Rehabilitation, Cross sectional studies, Social inclusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut de Sante Parasport Connecte SynergiesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 31 Mar 2022 (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.
People with disabilities are less physically active than the general population. At present, the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity are unknown.
The aim of this study is to describe the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity.
Detailed description
This is a cross-sectional, monocentric, cohort study of subjects with poliomyelitis sequelae followed in a Physical Medicine and Rehabilitation Department.
All consecutive eligible outpatient subjects consulting to the Physical Medicine and Rehabilitation Department of our university hospital will be included.
Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.
It is an ancillary study to the NO-AGING study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects with poliomyelitis sequelae | – | Other: standard of care for patients with poliomyelitis sequelae |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with poliomyelitis sequelae.
Key inclusion criteria (4 listed)
- Consulting to the Physical Medicine and Rehabilitation Department of our university hospital
- Having poliomyelitis sequelae
- No opposition to be enrolled in the study from the patient
- Affiliation to a social security scheme
Key exclusion criteria (4 listed)
- Disability that does not allow the completion of questionnaires
- Acute intercurrent medical situation
- Use of electric wheelchair
- Under court protection.
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 |
|---|---|---|
| standard of care for patients with poliomyelitis sequelaeclinical examination, radiological, biological and physiological examinations. | Other | All subjects with poliomyelitis sequelae |
Primary outcome
Physical activity level
Time frame: Baseline
Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) Questionnaire
1 secondary outcome
Barriers of physical activity
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Individual participant dataSharing planned: No
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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.
François Genêt, MD-PhD principal investigator
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
Vincent T Carpentier, MD-MSc study chair
Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poliomyelitis, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François Genêt, MD-PhD (+33 1 47 10 70 82, francois.genet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jan 2023.