Neuro-Orthopaedic Disorders During Aging in Patients With Neuromotor Disability

Disability or Chronic Disease Leading to Disablement Clinical Trial

— NO-AGING  

Official title:

Neuro-Orthopaedic Disorders During Aging in Patients With Neuromotor Disability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05294029
• Other study ID #: 2022-002
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: February 1, 2034

Study information

• Verified date: December 2022
• Source: Institut de Sante Parasport Connecte Synergies
• Contact: François Genêt, MD-PhD
• Phone: +33 1 47 10 70 82
• Email: francois.genet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 1, 2034
• Est. primary completion date: February 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Disability or Chronic Disease Leading to Disablement

Intervention

Other:
• standard of care for patients with neuromotor disability
clinical examination, radiological, biological and physiological examinations.

Locations

Country	Name	City	State
France	Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP	Garches

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Sante Parasport Connecte Synergies	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of mobility during aging	Walking range	Through study completion, an average of 1 year
Secondary	Prevalence of falls and fractures	Number and description of falls and fractures	Through study completion, an average of 1 year
Secondary	Characteristics of infiltrative procedures and surgeries	Number and description of infiltrative procedures and surgeries	Through study completion, an average of 1 year
Secondary	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
Secondary	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
Secondary	Evolution of comorbidities during aging	Prevalence of comorbidities (e.g. obesity, diabetes, hypertension, sleep apnea, ...)	Through study completion, an average of 1 year
Secondary	Medication	Medication list	Through study completion, an average of 1 year
Secondary	Prevalence of pressure sores	Number and description of pressure sores	Through study completion, an average of 1 year