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enGIneering For sporT for All (GIFT)

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
experimental ankle foot orthosis
traditional ankle foot orthosis
Sponsored by
IRCCS Eugenio Medea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring orthosis, hemiplegia

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS E. MedeaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

orthosis in hemiplegia

Arm Description

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

G- sensor with standard ankle foot orthosis
accelerometric evaluation during running and sprinting (linar parameters, velocity, step length, cadency) with standard orthosis
G- sensor with experimental ankle foot orthosis
accelerometric evaluation during running and sprinting (linar parameters, velocity, step length, cadency) with experimental orthosis

Full Information

First Posted
February 11, 2021
Last Updated
March 10, 2021
Sponsor
IRCCS Eugenio Medea
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1. Study Identification

Unique Protocol Identification Number
NCT04794114
Brief Title
enGIneering For sporT for All
Acronym
GIFT
Official Title
enGIneering For sporT for All
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
orthosis, hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
orthosis in hemiplegia
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
experimental ankle foot orthosis
Intervention Description
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
Intervention Name(s)
traditional ankle foot orthosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
gait analysis with standard ankle foot orthosis
Description
kinematic (joint angle during gait cycle) and kinetic evaluation (power generation and absorption and moments) both with standard orthosis
Time Frame
The evaluations are performed before the new ankle foot orthosis is delivered
Title
gait analysis with experimental ankle foot orthosis
Description
kinematic (joint angle during gait cycle) and kinetic evaluation (power generation and absorption and moments) both with experimental orthosis
Time Frame
The evaluations are performed 1 month after the new ankle foot orthosis is delivered
Secondary Outcome Measure Information:
Title
G- sensor with standard ankle foot orthosis
Description
accelerometric evaluation during running and sprinting (linar parameters, velocity, step length, cadency) with standard orthosis
Time Frame
The evaluations are performed before the new ankle foot orthosis is delivered
Title
G- sensor with experimental ankle foot orthosis
Description
accelerometric evaluation during running and sprinting (linar parameters, velocity, step length, cadency) with experimental orthosis
Time Frame
The evaluation is performed 1 month after the new ankle foot orthosis is delivered

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
luigi piccinini, m.d.
Phone
031877111
Ext
+39
Email
luigi.piccinini@lanostrafamiglia.it
Facility Information:
Facility Name
IRCCS E. Medea
City
Bosisio Parini
State/Province
LC
ZIP/Postal Code
23842
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
luigi piccinini, MD
Phone
031877111
Ext
+39
Email
luigi.piccinini@lanostrafamiglia.it

12. IPD Sharing Statement

Plan to Share IPD
No

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enGIneering For sporT for All

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