Actively Recruiting
Effects of Therapies in Acromegaly: Acral Morphofunctional Observational Study
Led by Istituto Auxologico Italiano · Updated on 2025-08-03
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Auxologico Italiano
Lead Sponsor
P
Politecnico di Milano
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acromegaly is a rare chronic condition caused mainly by a growth hormone-secreting pituitary tumor, leading to excess growth hormone and insulin-like growth factor-I. This excess results in increased health risks including joint problems like osteoarthritis and higher fracture risk. Researchers are studying how acromegaly and its treatments affect the size and function of patients' hands and feet using advanced scanning and movement analysis techniques, comparing new patients with those at different disease stages. This observational study uses a portable 3D laser scanning system to measure the geometric and volume characteristics of hands and feet. It also employs gait analysis technology to assess posture, balance, and walking patterns. Patients undergo various tests including standing with eyes open and closed, walking barefoot, and functional evaluations of foot and hand joint angles. These assessments are supported by video analysis and questionnaires that evaluate hand function. Participants will be assessed at the start and, for new patients receiving medical or surgical therapy, again at 3, 6, and 12 months after treatment begins. Researchers will measure changes in growth hormone and IGF-1 levels, posture control, gait parameters, and joint function of the hands and feet. This comprehensive evaluation helps understand how acromegaly and its treatments impact extremity morphology and movement over time.
CONDITIONS
Brief Title
Effects of Therapies in the Acromegaly Disease: Acral Morpho-functional Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- De novo patients with acromegaly diagnosed according to Endocrine Society guidelines
- Age 18 years or older
- Acromegalic patients with different disease status
- Age 18 years or older
You will not qualify if you...
- Cardiorespiratory, neurological, or musculoskeletal disorders
- Previous orthopedic surgery
- Previous lower limbs traumatic injuries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants with acromegaly, including those with different disease statuses, undergo initial morpho-functional evaluations of their hands and feet along with assessments of posture, balance, gait, and joint function.
1 baseline visit (in-person)
Duration - 12 months
De novo participants with acromegaly receive medical or surgical therapy following clinical guidelines. Morphofunctional examinations and disease stage evaluations are performed alongside therapy.
Visits at baseline, 3, 6, and 12 months (in-person)
Duration - Up to 12 months after treatment starts
Participants continue to have morpho-functional evaluations and disease assessments during and after treatment to observe changes in physical and functional parameters.
Visits at 3, 6, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Istituto Auxologico Italiano IRCCS San Luca
Milan, Italy, 20149
Actively Recruiting
Research Team
S
Sara Farina, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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