Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System

Status Not yet recruiting

Clinical Trial Summary

Development and validation study of a prognostic score - study of prognostic performance by a prospective longitudinal multicenter cohort spread over 8 centers: 4 for the development cohort and 4 for the validation cohort).

Clinical Trial Description

Progressive muscle weakness in neuromuscular diseases leads to motor disabilities leading to permanentfull-time wheelchair use. This is the case for infantile spinal muscular atrophy type II (SMA II), where people are dependent on a permanent sitting position from early childhood, at 2 years of age, or for Duchenne muscular dystrophy, when they lose their ability to walk around 10 years without corticosteroid therapy or around 13 years with treatment. These wheelchair users, weakened by the disease, are subject to musculotendinous retractions, osteo-articular stiffness, spinal deformities and pain. In addition, they use the wheelchair on a daily basis, on average 12 hours a day, whose permanent sitting position also conditions the performance of achieving life habits. The analysis of the static and dynamic seated postural installation in the wheelchair makes it possible to avoid harmful consequences on the health and quality of life of users on a daily basis. When performed early enough, regularly and optimally, it also contributes to the prevention of complications. In France, these assessments are carried out by occupational therapists, accompanied by doctors of Physical Medicine and Rehabilitation. The weakness of the literature in this area and the absence of recommendations do not allow the user or any health professional to identify the need and the level of urgency to benefit from a dedicated consultation. Faced with this observation, the development of a prognostic score for a change in positioning in the wheelchair, based on a prospective multicenter cohort and its validation on an external prospective cohort, will allow any healthcare professional to guide the user to a necessary positioning consultation. The hypothesis is that this score has discriminating qualities and that it is calibrated to predict a change in the seat of the RF and therefore the need to reassess the seated postural installation. ;

Study Design

Related Conditions & MeSH terms

Neuromuscular Diseases

Clinical Trial Details

NCT number	NCT05785546
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact	Samuel Pouplin, PhD
Phone	+ 33 (0)1.47.10.70.61
Email	samuel.pouplin@aphp.fr
Status	Not yet recruiting
Phase
Start date	October 2023
Completion date	March 2027

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03548779` - North Carolina Genomic Evaluation by Next-generation Exome Sequencing, 2	N/A
Completed	`NCT04435093` - Digitalization Playful Module of Motor Function Measure Assessment for Children With Neuromuscular Disorders, MFM-Play Pilot Study.
Not yet recruiting	`NCT04089696` - Validation of the "ExSpiron©" in Patients With ALS	N/A
Completed	`NCT01313325` - Hippotherapy to Improve the Balance of Children With Movement Disorders	N/A
Recruiting	`NCT04098094` - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Active, not recruiting	`NCT05070624` - The Peer Support Study	N/A
Completed	`NCT04729920` - Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases
Recruiting	`NCT04581577` - Perceptions of the Clinical and Psychosocial Impact of Covid-19 in Patients With Neuromuscular and Neurological Disorders
Enrolling by invitation	`NCT05539456` - Reliability and Validity of the Turkish Version of the PedsQL 3.0 Neuromuscular Module for 2-to 4- Year-old
Completed	`NCT05353738` - Efficacy of Vaccination Against COVID-19 in Patients Presenting a Neuromuscular Disease With Severe Amyotrophy
Recruiting	`NCT04541602` - Detection of Neuromuscular Complications in Critically Ill Patients
Completed	`NCT03394859` - Electronic Medical Records and Genomics (eMERGE) Phase III
Enrolling by invitation	`NCT05099107` - Changes of Motor Function Tests in Congenital Myopathy Subjects Treated With Oral Salbutamol as Compared to no Treatment	N/A
Completed	`NCT05070910` - NDT Effectiveness Study	N/A
Recruiting	`NCT04100993` - Multisystem and Autonomic Complications of NMD on Long-term NIV
Recruiting	`NCT04986059` - Effects of Pre-event Massage on Muscle Activity	N/A
Completed	`NCT01022931` - Epidemiology and Clinical Presentation of H1N1 Infection in Children in Geneva	N/A
Terminated	`NCT03353064` - Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure	N/A
Recruiting	`NCT05318638` - Soft-robotic Glove Support of High-demand Tasks	N/A
Completed	`NCT04837157` - Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Elaboration of a Pronostic Score of Changes on Wheelchair's Seating System — BPIP-Score MNM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms