Disability or Chronic Disease Leading to DisablementNO-AGINGNCT05294029
Neuro-Orthopaedic Disorders During Aging in Patients With Neuromotor Disability
An observational study of Disability or Chronic Disease Leading to Disablement, run by Institut de Sante Parasport Connecte Synergies at 1 site in France.
Trial summary
People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of worsening their neuro-orthopaedic disorders during aging, including fracture risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disability or Chronic Disease Leading to Disablement
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2022to 1 Feb 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 neuromotor disability
Who may be able to join
- Patients >= 18 years old ;
- Treated in the Neuro Orthopaedic Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital ;
- Having a neuromotor disability ;
- No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it ;
- Affiliation to a social security scheme.
Who cannot join
- Under court protection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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
People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of worsening their neuro-orthopaedic disorders during aging, including fracture risk. Nevertheless, at the present time, the natural evolution of their neuro-orthopedic disorders and the long-term functional impact of their medical and surgical treatments is unknown.
The aim of this study is to describe neuro-orthopedic disorders during aging of patients with neuromotor disability, their functional repercussions, their comorbidities and the therapeutic strategies used.
Read the detailed description
This is an ambispective, monocentric, cohort study of subjects with neuromotor disability followed in a Physical Medicine and Rehabilitation Department.
All consecutive eligible inpatient and outpatient subjects treated in the Neuro Orthopaedic Unit (UPOH) of 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.
- Being tested
- standard of care for patients with neuromotor disability
- Keywords
- Neuromotor Disability, Neuro-Orthopaedics
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 neuromotor disabilityOther
clinical examination, radiological, biological and physiological examinations.
| Study group | Role | What they receive |
|---|---|---|
| All subjects with neuromotor disability | Not described Receives: Other: standard of care for patients with neuromotor disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of mobility during aging
Walking range
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Prevalence of falls and fractures
Number and description of falls and fractures
Measured: Through study completion, an average of 1 year
Characteristics of infiltrative procedures and surgeries
Number and description of infiltrative procedures and surgeries
Measured: Through study completion, an average of 1 year
Changes of devices (orthoses and prostheses) and technical aids used during aging
Number and description of devices (orthoses and prostheses) and technical aids
Measured: Through study completion, an average of 1 year
Changes of physical activity, as well as barriers and facilitators to physical activity, during aging
Questionnaires assessing physical activity levels (ex: PASPID) and barriers and facilitators to physical activity (ex: BPAQ)
Measured: Through study completion, an average of 1 year
Evolution of comorbidities during aging
Prevalence of comorbidities (e.g. obesity, diabetes, hypertension, sleep apnea, ...)
Measured: Through study completion, an average of 1 year
Medication
Medication list
Measured: Through study completion, an average of 1 year
Prevalence of pressure sores
Number and description of pressure sores
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 May 2022
- Primary completion1 Feb 2032 (estimated)
- Study completion1 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability or Chronic Disease Leading to DisablementStudies 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
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
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 director, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294029
- Sponsor's protocol ID
- 2022-002
- Acronym
- NO-AGING
- Status last verified
- Dec 2022
- First submitted
- 5 Jan 2022
- Last updated
- 23 Dec 2022
- 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 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-Orthopaedic Disorders During Aging in Patients With Neuromotor Disability
- ClinicalTrials.gov ID
- NCT05294029
- Acronym / sponsor ID
- NO-AGING / 2022-002
- Keywords
- Neuromotor Disability, Neuro-Orthopaedics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 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 Feb 2032 (estimated)
- Study completion
- 1 Feb 2034 (estimated)
- First posted
- 24 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 neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at risk of worsening their neuro-orthopaedic disorders during aging, including fracture risk. Nevertheless, at the present time, the natural evolution of their neuro-orthopedic disorders and the long-term functional impact of their medical and surgical treatments is unknown.
The aim of this study is to describe neuro-orthopedic disorders during aging of patients with neuromotor disability, their functional repercussions, their comorbidities and the therapeutic strategies used.
Detailed description
This is an ambispective, monocentric, cohort study of subjects with neuromotor disability followed in a Physical Medicine and Rehabilitation Department.
All consecutive eligible inpatient and outpatient subjects treated in the Neuro Orthopaedic Unit (UPOH) of 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects with neuromotor disability | – | Other: standard of care for patients with neuromotor disability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with neuromotor disability
Key inclusion criteria (5 listed)
- Patients >= 18 years old ;
- Treated in the Neuro Orthopaedic Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital ;
- Having a neuromotor disability ;
- No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it ;
- Affiliation to a social security scheme.
Key exclusion criteria (1 listed)
- 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 neuromotor disabilityclinical examination, radiological, biological and physiological examinations. | Other | All subjects with neuromotor disability |
Primary outcome
Evolution of mobility during aging
Time frame: Through study completion, an average of 1 year
Walking range
7 secondary outcomes
Prevalence of falls and fractures
Time frame: Through study completion, an average of 1 year
Characteristics of infiltrative procedures and surgeries
Time frame: Through study completion, an average of 1 year
Changes of devices (orthoses and prostheses) and technical aids used during aging
Time frame: Through study completion, an average of 1 year
Changes of physical activity, as well as barriers and facilitators to physical activity, during aging
Time frame: Through study completion, an average of 1 year
Evolution of comorbidities during aging
Time frame: Through study completion, an average of 1 year
Medication
Time frame: Through study completion, an average of 1 year
Prevalence of pressure sores
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- 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.
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 director
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 Disability or Chronic Disease Leading to Disablement, 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Dec 2022. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evolution of mobility during aging (time frame: Through study completion, an average of 1 year). 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 23 Dec 2022.