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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05294029
Other study ID # 2022-002
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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