Clinical trial NCT05964712: Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study
Official title: Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acromegaly
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
First posted: 2023-07-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group #1: De novo patients with acromegaly, diagnosed according to Endocrine Society guidelines, aged equal or above 18 years old;

Group #2: Acromegalic patients with different disease status (active disease despite ongoing therapies, controlled disease under medical therapy, and disease remission), aged equal or above 18 years old

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 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in serum concentration of GH and IGF1
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
measure: Change in postural
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
measure: Gait analysis
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
measure: Change in function of the foot - angle ankle joint
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
measure: Change in function of the foot - angle subtalar joint
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
measure: Change in function of the foot - angle metatarsophalangeal joint of the big toe
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
measure: Change in Function of the hand - Dreiser functional index
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
measure: Change in Function of the hand - Duruöz hand index
timeFrame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Auxologico Italiano IRCCS San Luca
Study officials:
affiliation: Istituto Auxologico Italiano IRCCS
name: Giovanni Vitale
role: PRINCIPAL_INVESTIGATOR
References: