Active not recruitingNAINTERVENTIONAL

Randomized Controlled Trial of Early Intensive Leg Exercise to Improve Walking in Children With Diplegia

This study is investigating if early, intensive leg exercises can improve walking and movement in young children with a condition called spastic diplegia. This condition typically affects both legs and often results from brain injury in babies born prematurely. Currently, treatments are often passive, like braces. This trial will compare a 3-month program of focused leg exercises to the usual physiotherapy care. Researchers hope that very early and regular exercise could lead to children walking sooner and more easily. They will follow children until age four to see if the benefits last. This research aims to find better ways to help these children improve their movement.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Alberta

Enrolment target

Start

28 Jan 2019

Estimated completion

31 Mar 2027

Spastic Diplegia Periventricular Leukomalacia

What is this study about?

This research study is looking for better ways to help young children who have a type of cerebral palsy called spastic diplegia. This condition mainly affects the legs, making them stiff and difficult to move, which can make walking challenging. It often happens in babies born early because of a brain injury. Usually, treatments for this condition include things like leg braces, injections to relax stiff muscles, or surgery if problems develop. Often, active exercise sessions for weak muscles are not very frequent, perhaps only twice a month.

However, some studies on animals have shown that if young animals with early brain injuries get a lot of exercise very early on, it can help improve their condition. Our team has already seen good results using intensive therapy for children who had a stroke very early in life. Building on this knowledge, we want to see if the same idea applies to children with spastic diplegia by giving them lots of focused leg exercises.

We believe that if children with spastic diplegia start these special exercises early, it could help them move better, learn to walk sooner, and walk more easily. The study will also look at whether these improvements last over a long time and if this kind of therapy is a good use of resources. This could lead to new and better ways to help children with this condition achieve greater independence in their movement.

Key takeaways

This study explores if early, intense leg exercises can help children with spastic diplegia walk better.
Children will either get special exercises or standard care, with a chance for everyone to get the exercises eventually.
The therapy is play-based and guided by experts.
Researchers will track progress until age four to see long-term benefits.
The study aims to find more effective ways to help children with movement challenges.

Who may be eligible?

To join this study, children need to be between 8 months and 3 years old. They must have difficulties with movement in both legs due to premature birth and specific brain injury. They should also be able to stand with some help.

Children cannot join if they have significant problems with their arms, have uncontrolled seizures or infantile spasms within the last six months, or have heart or bone problems that would make intensive exercise unsafe. Also, if they've had specific muscle-relaxing injections in their legs in the last six months, they won't be able 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.

Is your child between 8 months and 3 years old?
Does your child have movement difficulties mainly in both legs due to early brain injury?
Can your child stand with some help?
Has your child NOT had significant arm problems?
Has your child been free from uncontrolled seizures or infantile spasms for the last 6 months?
Has your child NOT had specific muscle injections in their legs in the last 6 months?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will be randomly assigned to one of two groups, like flipping a coin. One group will start the intensive leg exercise therapy straight away for three months. The other group will delay starting the therapy for six months, acting as a comparison group to see how children improve without immediate treatment. After this six-month delay, children in the second group will have the option to receive the same intensive therapy.

The therapy itself will be guided by physical therapists and will involve play-based activities to make the exercises fun for your child. Throughout the study, we will take measurements before, during, and after these periods. These will include checking your child's motor skills, how well they walk, how much they participate in activities at home, and specific measurements of their muscle and sensory function. All children will be followed until they are 4 years old so we can understand if the benefits last for a long time. The total duration of active therapy for a child would likely be 3 months, with follow-up until age 4.

Potential risks and benefits

Taking part in this study may offer your child the potential benefit of improved walking and overall movement, which could last a long time. This active approach might help them achieve better independence. As with any exercise, there's a small risk of muscle soreness or fatigue. The exercises will be guided by physical therapists to ensure they are safe and appropriate for your child. Understanding that this is a research study, you have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (2)

Alberta Children's Hospital
Verified postcode
Calgary, Canada
University of Alberta
Verified postcode
Edmonton, Canada

Common questions

What is spastic diplegia?

It's a type of cerebral palsy where the legs are mainly affected, making them stiff and hard to move, often due to a brain injury that happened before or around birth.

Will my child definitely get the new therapy?

Your child will be randomly assigned to either receive the intensive therapy straight away or to a group that delays it for six months. However, the delayed group will have the option to receive the therapy afterwards.

How long will the therapy last?

The intensive leg exercise therapy itself will last for three months.

What does 'randomized controlled trial' mean?

It means children are put into different groups by chance. This helps researchers compare the new treatment fairly against standard care or a delay in treatment.

What happens after the treatment period?

All children will be followed until they turn four years old to see if the positive effects of the therapy are long-lasting.