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NCT Number: NCT05964712

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

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).

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS San Luca

Milan, 20149, Italy

Location status: Recruiting

Location contact

Giovanni Vitale

CONTACT

[email protected]

About this study

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:

  • 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;
  • 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:

  • Algo-functional index of the hand according to Dreiser, which analyzes the ability to execute some gestures of daily life;
  • Duruöz index, questionnaire for assessing functional impairment of hand.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical surgery therapy

Procedure

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.

Primary outcomes

  1. Change in serum concentration of GH and IGF1

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    Serum concentration of GH and IGF1

  2. Change in postural

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    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.

  3. Gait analysis

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    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.

  4. Change in function of the foot - angle ankle joint

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the ankle joint

  5. Change in function of the foot - angle subtalar joint

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the subtalar joint

  6. Change in function of the foot - angle metatarsophalangeal joint of the big toe

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    The functional evaluation of the foot involves positioning the patient prone/supine on the bed and assessing the metatarsophalangeal joint of the big toe

  7. Change in Function of the hand - Dreiser functional index

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    Algo-functional index of the hand according to Dreiser functional index

  8. Change in Function of the hand - Duruöz hand index

    Time frame: At baseline in population #1 and # 2 and at 3, 6, 12 months after intervention in population #1

    Algo-functional index of the hand according to Duruöz hand index

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Farina, Doctor

CONTACT

[email protected]

+393386822298

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • Politecnico di Milano

Registry information

Acronym: ACROMORFO

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2023
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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