enGIneering For sporT for All

NCT04794114 | Completed

• 1 other identifier: 713
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

orthosis; hemiplegia

Outcome Measures

Primary Outcomes (2)

• gait analysis with standard ankle foot orthosis

  kinematic (joint angle during gait cycle) and kinetic evaluation (power generation and absorption and moments) both with standard orthosis

  The evaluations are performed before the new ankle foot orthosis is delivered

• gait analysis with experimental ankle foot orthosis

  kinematic (joint angle during gait cycle) and kinetic evaluation (power generation and absorption and moments) both with experimental orthosis

  The evaluations are performed 1 month after the new ankle foot orthosis is delivered

Secondary Outcomes (2)

• G- sensor with standard ankle foot orthosis

  The evaluations are performed before the new ankle foot orthosis is delivered

• G- sensor with experimental ankle foot orthosis

  The evaluation is performed 1 month after the new ankle foot orthosis is delivered

Study Arms (1)

orthosis in hemiplegia

EXPERIMENTAL

Device: experimental ankle foot orthosis; Device: traditional ankle foot orthosis

Interventions

experimental ankle foot orthosis 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.

orthosis in hemiplegia

traditional ankle foot orthosis 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.

orthosis in hemiplegia

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, LC, 23842, Italy

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: March 11, 2021
• Study Start: September 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)