NCT05294029

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
May 2022Feb 2034

First Submitted

Initial submission to the registry

January 5, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 24, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2032

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2034

Last Updated

December 23, 2022

Status Verified

December 1, 2022

Enrollment Period

9.8 years

First QC Date

January 5, 2022

Last Update Submit

December 21, 2022

Conditions

Keywords

Neuromotor Disability, Neuro-Orthopaedics

Outcome Measures

Primary Outcomes (1)

  • Evolution of mobility during aging

    Walking range

    Through study completion, an average of 1 year

Secondary Outcomes (7)

  • Prevalence of falls and fractures

    Through study completion, an average of 1 year

  • Characteristics 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

    Through study completion, an average of 1 year

  • Changes of physical activity, as well as barriers and facilitators to physical activity, during aging

    Through study completion, an average of 1 year

  • Evolution of comorbidities during aging

    Through study completion, an average of 1 year

  • +2 more secondary outcomes

Study Arms (1)

All subjects with neuromotor disability

Other: standard of care for patients with neuromotor disability

Interventions

clinical examination, radiological, biological and physiological examinations.

All subjects with neuromotor disability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with neuromotor disability

You may qualify if:

  • 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.

You may not qualify if:

  • Under court protection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Garches, 92380, France

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • François Genêt, MD-PhD

    Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

    PRINCIPAL INVESTIGATOR
  • Vincent T Carpentier, MD-MSc

    Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

    STUDY DIRECTOR

Central Study Contacts

François Genêt, MD-PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

March 24, 2022

Study Start

May 1, 2022

Primary Completion (Estimated)

February 1, 2032

Study Completion (Estimated)

February 1, 2034

Last Updated

December 23, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations