Cerebral Palsy Clinical Studies with Children

Characteristics and Prevalence of Cerebral Palsy

Cerebral palsy is the leading cause of motor disability in children. By definition, cerebral palsy is a group of disorders that affect a person’s ability to move and maintain balance and posture (CDC). Therefore, motor rehabilitation is essential in its management. Above all, it is important to focus on the autonomy, participation, and quality of life of the individual.

According to the Cerebral Palsy Alliance Research Foundation:

• Worldwide, around 18 million people of all ages have cerebral palsy.
• Approximately 1 million people have cerebral palsy in the US.
• 1 in 323 babies are diagnosed with cerebral palsy in the US.

Thus, researchers are continuously searching for new, effective, and validated rehabilitation therapies. For that reason, Ubique Tech is participating in research projects with its motor rehabilitation device, HabilUp.

Clinical Pre-Study : Children with Cerebral Palsy (France)

In 2020, Ubique Tech carried out its first clinical pre-study in partnership with the Institute of Motor Eduction of Château de Bailly in Île-de-France. HabilUp was tested with 15 children with cerebral palsy between the ages of 3 and 18 years old.

Results

Firstly, the results of this study confirmed that the HabilUp motor rehabilitation device aided the children to nearly triple the number of movement repetitions.

Secondly, the children were also more engaged and joyful during rehabilitation sessions while using the device. They remained interested and motivated to play, and, thus, continued to do their exercises.

Furthermore, this outcome aligns with the results at the Institute of Motor Education of La Croix Faubin in Paris. HabilUp was introduced to the facility in January 2019. It is utilized once a week with children with cerebral palsy who do not use their ankle. To date, more than 5 children have regained the use of their ankle.

Clinical Studies : Children with Cerebral Palsy (France)

In addition, a clinical study of HabilUp at the Grenoble University Hospital will begin in December 2022.

Study Question

Does HabilUp accelerate the remission phases of a child with cerebral palsy in comparison to traditional motor therapies?

Objectives

This study has two objectives:

1. To show that the HabilUp system increases the number of movement repetitions during a motor rehabilitation session.
2. Sub-objective 1 : To show that the HabilUp system improves the amplitude of the joint. In addition, it increases the precision and speed of the movement.
   Sub-objective 2: To show that the HabilUp system reduces the amount of pain felt during the exercise.

Target Population

• Children ages 6 to 18 years of age
• Diagnosed with cerebral palsy
• Capable of understanding the instructions and conceptualizing the effect of their movements with the screen

Procedure

30 children with cerebral palsy will be included in this study over a period of 12 months. The total participation duration of each subject is 3 months. This study will be mulicentric, prospective, randomized, controlled, and open.

1. Period 1 (15 days): All children will perform their usual rehabilitation exercises for a minimum of two sessions per week.
2. Period 2 (1.5 months): All children will perform their usual rehabilitation exercises while wearing the HabilUp sensors and playing the video games. A minimum of two sessions per week is required.Randomization:
3. Period 3 (1 month): 15 children will continue performing their usual rehabilitation exercises while wearing the HabilUp sensors and playing the video games. 15 children will perform their usual rehabilitation exercises without wearing the sensors. A minimum of two sessions per week is required.

Importance

Undoubtably, the search for new, effective, and validated rehabilitation therapies is a major challenge in caring for children with motor disabilities. The sensors of the HabilUp system make it possible to measure and precisely characterize the movements made. At the same time, the interface in the form of games makes it possible to encourage children during their rehabilitation.

Ubique Tech anticipates that the utilization of the HabilUp system will increase the motivation of children during their rehabilitation sessions in comparison to traditional therapy methods.

Future Clinical Studies : Children with Cerebral Palsy (USA)

At the present time, Ubique Tech is in the first stages of designing and beginning clinical studies with its research partners in the United States. With the help of our collaborators, we can continue to provide accessible rehabilitation technology to children with motor disabilities in the United States. Thank you to the International Institute of the Brain in Manhattan, New York and Fortis Therapy Center in Dripping Springs, Texas for conducting these trials!