RecruitingNAINTERVENTIONAL

Evaluation of an Intensive Training Program for Patients with Hereditary Spastic Paraparesis SPG4/Spast

This study is for people with a genetic condition called Hereditary Spastic Paraparesis (SPG4), which affects how you move your legs. Many people with this condition feel that physiotherapy helps them, especially with muscle stiffness. This study aims to find out if having more frequent physiotherapy effectively improves walking speed. Researchers will compare two groups of patients: one group will continue their usual physiotherapy, while the other will have extra, intensive exercise sessions. They want to see if these extra sessions make a real, measurable difference to how well people walk.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

04 Apr 2024

Estimated completion

01 Oct 2026

Hereditary Spastic Paraparesis

What is this study about?

Hereditary Spastic Paraparesis (HSP) is a group of inherited brain and nerve conditions that mainly cause stiffness and weakness in the legs. For now, treatments primarily help with the symptoms, rather than curing the condition itself. Our research team previously found that people with HSP felt that physiotherapy, especially when done often, was really helpful for easing leg stiffness.

Building on this, the 'WALK-UP' study wants to measure if this feeling of effectiveness is true. Specifically, we want to see if an intensive exercise programme can truly improve walking difficulties for people with SPG4/Spast – which is the most common form of HSP. We believe that doing physiotherapy more often (about three extra sessions a week) could lead to significant improvements in walking speed.

This study involves physical training and will compare two groups of patients. One group will continue with their current physiotherapy, and the other will have a more intense exercise program. By comparing these groups, we hope to show a clearer picture of how effective this extra training can be in helping people with HSP to walk better.

Key takeaways

This study explores if more frequent physiotherapy improves walking for people with SPG4.
It involves an intensive, 6-week exercise program for some participants.
The main goal is to measure changes in walking speed.
You need a specific genetic link (SPAST gene fault) to be eligible.
Participation requires internet access and existing physiotherapy.
You can leave the study at any time.

Who may be eligible?

To join this study, you need to have a confirmed genetic diagnosis of Hereditary Spastic Paraparesis caused by a fault in the SPAST gene (also known as SPG4). You must be able to walk by yourself for at least 6 minutes, even if you use aids like a cane, walker, or leg supports. You should also already be having at least one physiotherapy session per week. It's important that you understand what the study involves and can access the internet from home to view educational videos.

There are also some reasons why you wouldn't be able to join. For example, if you've had a special injection (Botulinum toxin) in the last two months or if you stop your regular physiotherapy. You also can't be pregnant, be taking part in another study that tests a new treatment, or be under certain legal arrangements like guardianship. You also need to be part of a social security scheme, like NHS in the UK, to participate.

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.

Do I have a confirmed genetic diagnosis of Hereditary Spastic Paraparesis (SPG4)?
Can I walk on my own for at least 6 minutes, even if I use a walking aid?
Am I currently having at least one physiotherapy session per week?
Do I understand what the study involves and agree to its requirements?
Do I have internet access at home?
Am I over 18 years old?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of two groups. One group will continue with their usual physiotherapy sessions (at least one per week) with their own therapist. The other group will also have their usual physiotherapy, but they will additionally take part in an intensive exercise program. This program will involve about three extra exercise sessions each week over 6 weeks. These extra sessions might include exercises you do at home, potentially guided by online materials.

Throughout the study, we will check your walking speed and other physical abilities to see if there are any changes. You'll have initial assessments, and then follow-up assessments during and after the 6-week intensive period. The total duration of your active participation, including assessments, will be a few months, with the main intensive training lasting 6 weeks.

Potential risks and benefits

Potential benefits of taking part include the possibility of improved walking speed and physical function, particularly if you are in the intensive training group. This study could also provide valuable information to help others with Hereditary Spastic Paraparesis in the future. As with any exercise programme, there’s a small risk of muscle soreness or mild injury, which will be monitored. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

ICM, Hôpital Pitié-Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is Hereditary Spastic Paraparesis (SPG4)?

It's a genetic condition that causes stiffness and weakness, mostly in the legs, making walking difficult over time.

What will I have to do in this study?

You'll either continue your regular physiotherapy or have extra, intensive exercise sessions for 6 weeks, alongside your regular sessions. We'll also measure your walking and physical abilities.

Will I or my doctor choose which group I'm in?

No, you will be randomly assigned to one of the two groups, like flipping a coin. Neither you nor your doctor can choose.

Do I need to pay for the extra physiotherapy?

The study aims to evaluate an intensive program, and details about funding for additional sessions for the intervention group would be fully explained by the study team before you agree to participate.

What happens after the 6 weeks of intensive training?

After the 6 weeks, you will continue to be monitored with assessments to see if any improvements are maintained. The study team will provide more details on long-term follow-up.

How to find out more

Pauline Lallemant, MD

pauline.lallemant@icm-institute.org 1. 57.27.46.69 Official trial record

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