enGIneering For sporT for All

NCT ID: NCT04794114

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-11-30

Brief Summary

hemiplegia is a pathological condition that affects one side of the body which is associated with difficulty in maintaining an upright posture and walking and which is commonly compensated for by using orthoses (AFO). However, the orthoses are inadequate for sports from a design and prescription point of view, which specifies that the goal of the orthosis is to support walking and that any other use compromises its reliability.

The main objective therefore provides for an improvement in the involvement of these children in sports activities (both at school and during leisure time) through the development of new generation orthoses.

Detailed Description

The main objective therefore provides for an improvement in the involvement of these children in sports activities (both at school and during leisure time) through the development of new generation orthoses.

Secondary objective: the second objective involves the verification of the orthosis previously designed and built, ie the device must comply with the project specifications and allow the patient to perform sports activities. Correct functioning will be tested by functional evaluation of the model developed through biomechanical analysis of movement performed indoors (in the laboratory) and outdoors.

Notes on the calculation of the sample size: the project foresees the involvement at the moment of 20 children with hemiplegia under treatment at MEDEA to whom an overall improvement of the living conditions is to be guaranteed.

Steps: 1-Technology design - "to play together" 2 - Analysis and identification of the guidelines for the prescription of use; 3 - Evaluation of the motor biomechanical situation of subjects wearing orthoses: indoor and outdoor to evaluate the limits of the orthosis used; 4 - identification of indicators for the evaluation of motor performance; 5 - Identification of the technical specifications (functional and clinical, mechanical, structural, geometric, materials, design) of the new generation orthosis-sensor system.

6- Definition of inclusion criteria, recruitment of 20 subjects starting from Medea and contacts with schools and families to which they belong.

7- Validation- "to verify it really runs" WP5.1 - Functional evaluation of the model developed through biomechanical analysis of movement carried out in the laboratory.

The I.R.C.C.S E. Medea will appropriately select 20 children with hemiplegia and wearers of orthoses.

A biomechanical assessment will be performed through gait analysis to identify the limits of the orthosis used.

8- Two conditions will be evaluated:

• walking tests without orthoses;
• walking tests with orthoses usually used. From the comparative analysis of the collected data, the criticalities of the device will be defined in order to identify the project specifications of the new generation orthosis.

9-Following the design and construction of the new AFO, a biomechanical evaluation will be performed again by means of gait analysis to validate its correct functioning.

10- Further validation will be performed using virtual reality environments (GRAIL Gait Real time Analysis Interactive Lab).

After a rehabilitation process, once a certain degree of confidence has been reached in the use of the new orthosis, the device will be tested using outdoor wearable sensors. By doing so, it will be possible to identify indicators for the evaluation of sports performance.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

orthosis in hemiplegia

Group Type: EXPERIMENTAL

experimental ankle foot orthosis

Intervention Type: DEVICE

On the basis of an accurate kinetic and kinematic analysis, a customized orthosis in thermoplastic material with carbon inserts will be created that will make the brace more elastic and facilitate the child's motor activities.

traditional ankle foot orthosis

Intervention Type: DEVICE

The normal afos in thermoplastic material, while guaranteeing an ankle joint stability, make the joint more rigid and reduce the elasticity of movement especially during running, jumping and sprinting.

Interventions

experimental ankle foot orthosis

On the basis of an accurate kinetic and kinematic analysis, a customized orthosis in thermoplastic material with carbon inserts will be created that will make the brace more elastic and facilitate the child's motor activities.

Intervention Type: DEVICE

traditional ankle foot orthosis

The normal afos in thermoplastic material, while guaranteeing an ankle joint stability, make the joint more rigid and reduce the elasticity of movement especially during running, jumping and sprinting.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Users of Ankle Foot Orthosis (AFO) without any time limit;
• GMFCS 1-2 scale values;
• Ashworth triceps sural values <= 3.

Exclusion Criteria

• patients using knee and hip orthoses (KAFO, HKAFO);
• patients who need assisted walking (use of crutches, walkers or other);
• uncooperative patients.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS E. Medea

Bosisio Parini, LC, Italy

Countries

Italy

Other Identifiers

713

Identifier Type: -

Identifier Source: org_study_id