Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study

Acromegaly Clinical Trial

— ACROMORFO  

Official title:

Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964712
• Other study ID #: 40C901
• Status: Recruiting
• Start date: June 18, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Sara Farina, Doctor
• Phone: +393386822298
• Email: sara.farina[@]unimi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 GH/IGF-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).

Description:

This is an observational, prospective study that aims to evaluate the effect of acromegalic disease and medical/surgical 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 prone/supine 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• De novo patients with acromegaly (group # 1), diagnosed according to Endocrine Society guidelines,

• Age equal to18 years or older

• Acromegalic patients with different disease status (group #2)

• Age equal to18 years or older

Exclusion Criteria:

• Cardiorespiratory, neurological or musculoskeletal disorder

• Previous orthopaedic surgery

• Previous lower limbs traumatic injuries

Related Conditions & MeSH terms

• Acromegaly

Intervention

Procedure:
• Medical surgery therapy
De novo patients with acromegaly will undergo medical/surgical therapy of this disease, according to the guidelines of the Endocrine Society. In this population (group #1) morpho-functional examinations together with the evaluation of the stage of the disease, with serum dosage of GH and IGF-1, will be performed at baseline and at months 3, 6 and 12 after initiating the treatment.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS San Luca	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano	Politecnico di Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum concentration of GH and IGF1	Serum concentration of GH and IGF1	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Primary	Change in postural	The postural evaluation was performed for 60 seconds while the participants were standing on a baropodometric platform (P-Walk, BTSBioengineering, Italy). They were instructed to maintain an upright position, with their eyes focused on a 6 cm black circle placed at their individual eye level, at a distance of 1.5 meters. Subsequently, they were asked to repeat the same task with their eyes closed. To avoid any learning or fatigue effects, two evaluations were acquired with open eyes and two with closed eyes, and between each trial, the subjects were allowed to rest and sit for 2 minutes, maintaining the foot position during the tests.; Postural parameters were calculated using dedicated software (G-Studio, BTS, Italy). The relative range of the center of pressure track length is essentially the difference between the maximum and minimum CoP position in the anterior-posterior and medial-lateral (ML) directions during the maintenance of the upright posture.	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Primary	Gait analysis	All participants were evaluated with 3D-Gait Analysis using an optoelectronic system composed of eight cameras (SMARTDX, BTSBioengineering, Italy) set at 100 Hz, and two force platforms (AMTI, USA). To evaluate the kinematics of each body segment, passive markers were positioned on the participants' body, as described by Davis III et al., and the underlying skeletal model was scaled on behalf of anthropometric data (height, weight, tibial length, distance between the femoral condyles or diameter of the knee, distance between the malleoli or diameter of the ankle, distance between the anterior iliac spines and thickness of the pelvis).; After placing the markers, the participants were asked to walk barefoot at self-selected speed along a walkway where the force platforms were embedded. Kinematic and kinetic data were collected for each individual from at least five trials to guarantee the reproducibility of the results.	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Primary	Change in function of the foot - angle ankle joint	The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the ankle joint	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Primary	Change in function of the foot - angle subtalar joint	The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the subtalar joint	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Primary	Change in function of the foot - angle metatarsophalangeal joint of the big toe	The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the metatarsophalangeal joint of the big toe	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Primary	Change in Function of the hand - Dreiser functional index	Algo-functional index of the hand according to Dreiser functional index	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Primary	Change in Function of the hand - Duruöz hand index	Algo-functional index of the hand according to Duruöz hand index	At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1