RecruitingNAINTERVENTIONAL

Intensive Psychomotor Rehabilitation on Cognitive Motor Abilities and Adaptive Capacity on Children With Polyhandicap

This study is investigating whether a specific type of intensive physical and mental therapy, called intensive psychomotor rehabilitation, can help children aged 4 to 13 years who have severe multiple disabilities (polyhandicap). Researchers want to compare this focused therapy with the care children usually receive, to see if it makes a difference to their everyday skills and movements after a year. They will also look at whether improvements last, how it affects families and caregivers, and if it causes any discomfort. The goal is to understand if this intensive therapy can improve the children's ability to do daily activities and develop motor skills more effectively than standard care.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

20 Jun 2022

Estimated completion

01 Jan 2026

Polyhandicap

What is this study about?

Imagine a study designed to help children who have 'polyhandicap' – a term used for children with severe multiple disabilities affecting their thinking, movement, and daily independence. This particular study is asking whether a special program of 'intensive psychomotor rehabilitation' makes a bigger difference than the usual care these children receive.

'Intensive psychomotor rehabilitation' means a very focused and hands-on therapy that aims to improve both mental and movement skills. The main goal is to see if, after a year, children receiving this intensive therapy show better improvements in their ability to cope with daily life compared to those receiving standard care. This is really important because better daily living skills can significantly improve a child's quality of life and that of their family.

Beyond just daily skills, the study will also look at different aspects. For example, they'll check development at different times, try to understand any pain the children might experience, see if any improvements gained from the therapy last over time, and even consider how the therapy affects the well-being of the families and the professional carers involved. This comprehensive look helps researchers get a full picture of the treatment's impact.

Key takeaways

The study compares a special intensive therapy to usual care for children with severe multiple disabilities.
It focuses on improving everyday skills and movements.
Children aged 4-13 with specific severe disabilities are eligible.
The study also looks at how the therapy affects families and caregivers.
Participation involves assessments over 18 months.

Who may be eligible?

This study is looking for children aged between 4 and 13 years old who have severe multiple disabilities, often called 'polyhandicap'. This means they would have had a brain injury before age 3, have significant learning difficulties (with an IQ generally below 40 or not measurable), and problems with movement like weak limbs, balance issues, or uncontrolled body movements. Their ability to move and do daily activities would also be quite limited.

To join, the child must be an inpatient in a hospital or clinic taking part in the study and be covered by social security. A parent or legal guardian must give written permission for their child to participate.

Children cannot join if they have certain conditions that get worse over time, such as some brain disorders, epilepsy that is not well controlled, or other diseases that progressively damage the brain. Also, if they are likely to move to another care setting or if following them up in the study would be very difficult, they won't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 4 and 13 years old?
Does your child have severe multiple disabilities from a brain injury before age 3?
Does your child have significant learning difficulties and motor problems?
Is your child currently an inpatient in a participating hospital or clinic?
Does your child NOT have a progressive brain disease or uncontrolled epilepsy?

Answer every question to see your result.

What does participation involve?

We don’t have all the details about what specifically taking part involves, but here's what we know from similar studies. If your child joins, they would either receive the intensive psychomotor rehabilitation or continue with their usual care for a total of 12 months. This therapy is hands-on and aims to improve both mental and movement skills.

Throughout the study, at specific times like 6 months and 12 months, your child will have assessments. These check their everyday skills, development, and pain levels. There will also be a follow-up assessment 6 months after the main treatment period ends (so, 18 months after starting the study) to see if improvements last. You and other family members, as well as professional caregivers, might be asked about your quality of life. The total duration of active participation and follow-up would be around 18 months.

Potential risks and benefits

While we don't have specific details on benefits or risks for this study, generally, potential benefits of taking part in a study like this could include receiving a specialised, intensive therapy that might improve your child's everyday skills and movements. There's also the chance to help advance medical understanding for other children with similar conditions. Potential risks could include the time commitment required for assessments and possible challenges with transport to appointments. As with any medical study, there's always the option to withdraw your child at any time, for any reason, without it affecting their ongoing care.

Locations (1)

Hôpital San Salvadour
Verified postcode
Hyères, France· Recruiting

Common questions

What does 'polyhandicap' mean?

It means a child has significant multiple disabilities, affecting their thinking, movement, and ability to do daily activities.

What is 'intensive psychomotor rehabilitation'?

It's a very focused and hands-on type of therapy designed to improve both mental and movement skills.

How long will the study last for my child?

The main part of the study lasts 12 months, with a follow-up assessment at 18 months after starting.

Will my child get the special new therapy?

Children in the study will be randomly assigned to receive either the intensive therapy or their usual care. It's not guaranteed they will get the new therapy.

What if we decide not to continue in the study?

You can withdraw your child from the study at any time, for any reason, and it will not affect their ongoing medical care.

How to find out more

Marie-Christine ROUSSEAU, MD

marie-christine.rousseau@aphp.fr +33 (4) 94 38 08 17 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.