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NCT Number: NCT05294029

Neuro-Orthopaedic Disorders During Aging in Patients With Neuromotor Disability

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Garches, 92380, France

Location status: Recruiting

Location contact

François Genêt

PRINCIPAL_INVESTIGATOR

Hélène Le Liepvre

SUB_INVESTIGATOR

Marjorie Salga

SUB_INVESTIGATOR

Vincent T Carpentier

CONTACT

Vincent T. Carpentier

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Under court protection.

Treatment and study plan

standard of care for patients with neuromotor disability

Other

clinical examination, radiological, biological and physiological examinations.

Primary outcomes

  1. Evolution of mobility during aging

    Time frame: Through study completion, an average of 1 year

    Walking range

Secondary outcomes

  1. Prevalence of falls and fractures

    Time frame: Through study completion, an average of 1 year

    Number and description of falls and fractures

  2. Characteristics of infiltrative procedures and surgeries

    Time frame: Through study completion, an average of 1 year

    Number and description of infiltrative procedures and surgeries

  3. Changes of devices (orthoses and prostheses) and technical aids used during aging

    Time frame: Through study completion, an average of 1 year

    Number and description of devices (orthoses and prostheses) and technical aids

  4. 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

    Questionnaires assessing physical activity levels (ex: PASPID) and barriers and facilitators to physical activity (ex: BPAQ)

  5. Evolution of comorbidities during aging

    Time frame: Through study completion, an average of 1 year

    Prevalence of comorbidities (e.g. obesity, diabetes, hypertension, sleep apnea, ...)

  6. Medication

    Time frame: Through study completion, an average of 1 year

    Medication list

  7. Prevalence of pressure sores

    Time frame: Through study completion, an average of 1 year

    Number and description of pressure sores

Study contacts

Contact information is provided by the study sponsor or research team.

François Genêt, MD-PhD

CONTACT

[email protected]

+33 1 47 10 70 82

Vincent T Carpentier, MD-MSc

CONTACT

[email protected]

+33 1 47 10 70 82

Sponsors and collaborators

Lead sponsor

Institut de Sante Parasport Connecte Synergies

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris

Registry information

Acronym: NO-AGING

Important dates

Study start
2022
Primary completion
2032
Study completion
2034
First posted
Mar 24, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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