Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964712
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-03-02
Brief Title:
Effects of Therapies in the Acromegaly Disease Acral Morpho-functional Study
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Effects of Therapies in the Acromegaly Disease Acral Morpho-functional Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACROMORFO
Brief Summary:
Acromegaly is a rare chronic disease due to excessive secretion of growth hormone GH and insulin-like growth factor-I IGF-I caused in over 98 of cases by GH-secreting pituitary adenoma Prolonged exposure to GHIGF-I excess is the cause of increased mortality and morbidity in these patients Arthropathy occurs in about 75 of acromegalic patients Any joint may be affected with the development of osteoarthritis arthralgia and an increase in fracture risk
The aims of the present project are to evaluate the dimensions of hands and feet with the 3D scanner method and to perform a quantitative analysis of movement through Gait Analysis technique in de novo patients with acromegaly group 1 and in patients with different disease status group 2
The aims of the present project are to evaluate the dimensions of hands and feet with the 3D scanner method and to perform a quantitative analysis of movement through Gait Analysis technique in de novo patients with acromegaly group 1 and in patients with different disease status group 2
Detailed Description:
This is an observational prospective study that aims to evaluate the effect of acromegalic disease and medicalsurgical therapy on acral morpho-functional alterations
To outline the morphological characteristics of the extremities hands and feet a three-dimensional laser scanning system will be used able to measure the geometrical and volumetric characteristics of the hands and feet of these subjects The three-dimensional scanning system that will be used is the portable FastScan system marketed by Rodin previously used for the volumetric evaluation of the lower and upper limbs of subjects suffering from lymphedema and lipedema The processing of the image and the parameters will be carried out through two softwares Rodin4DScan which carries out the reconstruction of the shape after the scan and Rodin4D which allows the construction of the final shape and allows the processing of the various parameters to the morphology of the extremity
The following tests will be used to characterize posture and balance control during walking
maintenance of the bipedal indifferent orthostatic posture with open and closed eyes
walking on level ground barefoot at natural speed 10 m walking test
The instrumentation BTS GAITLAB that will be used consists of
8-camera stereophotogrammetric system SMART DX BTS-Bioengineering IT
two dynamometric platforms AMTI USA
a baropodometric platform P-WALK BTS-Bioengineering IT
The variables analyzed will be divided according to the administered tests
1 maintenance of the orthostatic posture anteroposterior and mediolateral excursion of the center of pressure speed of displacement of the center of pressure length of postural ball and distribution of plantar pressures
2 gait spatio-temporal parameters kinematics of trunk and joints of lower limbs ground reaction forces moments and joint powers
A functional evaluation of the foot will be also performed positioning the patient pronesupine on the bed and measuring several joint angles
The measurement will be supported by a video from which images can be subsequently processed to trace and obtain the joint angles
For the functional evaluation of the hand the patient will be evaluated with the following outcome measures
1 Algo-functional index of the hand according to Dreiser which analyzes the ability to execute some gestures of daily life
2 Duruöz index questionnaire for assessing functional impairment of hand
To outline the morphological characteristics of the extremities hands and feet a three-dimensional laser scanning system will be used able to measure the geometrical and volumetric characteristics of the hands and feet of these subjects The three-dimensional scanning system that will be used is the portable FastScan system marketed by Rodin previously used for the volumetric evaluation of the lower and upper limbs of subjects suffering from lymphedema and lipedema The processing of the image and the parameters will be carried out through two softwares Rodin4DScan which carries out the reconstruction of the shape after the scan and Rodin4D which allows the construction of the final shape and allows the processing of the various parameters to the morphology of the extremity
The following tests will be used to characterize posture and balance control during walking
maintenance of the bipedal indifferent orthostatic posture with open and closed eyes
walking on level ground barefoot at natural speed 10 m walking test
The instrumentation BTS GAITLAB that will be used consists of
8-camera stereophotogrammetric system SMART DX BTS-Bioengineering IT
two dynamometric platforms AMTI USA
a baropodometric platform P-WALK BTS-Bioengineering IT
The variables analyzed will be divided according to the administered tests
1 maintenance of the orthostatic posture anteroposterior and mediolateral excursion of the center of pressure speed of displacement of the center of pressure length of postural ball and distribution of plantar pressures
2 gait spatio-temporal parameters kinematics of trunk and joints of lower limbs ground reaction forces moments and joint powers
A functional evaluation of the foot will be also performed positioning the patient pronesupine on the bed and measuring several joint angles
The measurement will be supported by a video from which images can be subsequently processed to trace and obtain the joint angles
For the functional evaluation of the hand the patient will be evaluated with the following outcome measures
1 Algo-functional index of the hand according to Dreiser which analyzes the ability to execute some gestures of daily life
2 Duruöz index questionnaire for assessing functional impairment of hand
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None