Neuro-Orthopaedic Disorders During Aging in Patients With Neuromotor Disability (NO-AGING)

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.

Study Overview

• Status: Recruiting
• Conditions: Disability or Chronic Disease Leading to Disablement
• Intervention / Treatment: Other: standard of care for patients with neuromotor disability

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
    • Sub-Investigator: Marjorie Salga
    • Contact: Vincent T Carpentier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with neuromotor disability

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All subjects with neuromotor disability	Other: standard of care for patients with neuromotor disability; clinical examination, radiological, biological and physiological examinations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of mobility during aging	Walking range	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of falls and fractures	Number and description of falls and fractures	Through study completion, an average of 1 year
Characteristics of infiltrative procedures and surgeries	Number and description of infiltrative procedures and surgeries	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	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)	Through study completion, an average of 1 year
Evolution of comorbidities during aging	Prevalence of comorbidities (e.g. obesity, diabetes, hypertension, sleep apnea, ...)	Through study completion, an average of 1 year
Medication	Medication list	Through study completion, an average of 1 year
Prevalence of pressure sores	Number and description of pressure sores	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Institut de Sante Parasport Connecte Synergies
• Collaborators: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): February 1, 2032
• Study Completion (Anticipated): February 1, 2034

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Neuromotor Disability, Neuro-Orthopaedics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2022-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No