Technological Balance Rehabilitation in Feed and Eating Disorders

NCT06641973 | Not Yet Recruiting

• 1 other identifier: 6656
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Postural control depends on the central integration of vestibular, visual, and somatosensory inputs and the integrity of the neural efferent motor pathway, which continuously provides postural adjustments to environmental and body position changes. It is considered a complex skill and involves the integration of movement strategies necessary for maintaining balance. Decreased postural control can induce instabilities that affect the performance of daily activities and increase the risk of falls. Decreased postural control can be linked to fluctuations in body weight: significant weight gain or loss, in fact, can induce musculoskeletal adaptations , which contribute to postural and motor alterations . In Italy, approximately 3 million people are affected by Feed and Eating Disorders (FED), which include, among others, anorexia nervosa (AN), bulimia nervosa (BN) and uncontrolled eating disorder (UED). There are works in the literature highlighting that both anorexic and obese patients present with impaired postural control and, consequently, reduced balance.

Conditions

Feeding Disorders; Anorexia Nervosa; Bulimia Nervosa

Keywords

Rehabilitation; Feeding Disorders

Outcome Measures

Primary Outcomes (1)

• Proprioception

  Improved proprioception as assessed by reduction of Center of Pressure (COP) oscillations using the hunova robotic platform

  Change from Baseline proprioception at 5 weeks

Secondary Outcomes (19)

• Berg Balance Scale (BBS)

  Change from Baseline BBS at 5 weeks

• Timed Up and Go Test (TUG)

  Change from Baseline TUG at 5 weeks

• Short Physical Performance Battery (SPPB)

  Change from Baseline SPPB at 5 weeks

• Timed-25 Foot Walk (T25FW)

  Change from Baseline T25FW at 5 weeks

• Mental Deterioration battery (MDB)

  Change from Baseline MDB at 5 weeks

Study Arms (2)

Experimental Group (G-Hun)

EXPERIMENTAL

The experimental group (G-Hun), will carry out robotic balance treatment with the hunova® robotic platform lasting 30 minutes per session, 2 times a week for 5 weeks, in addition to their clinical pathway services.

Device: Robotic balance rehabilitation with hunova® robotic platform

Control Group (G-Con)

NO INTERVENTION

Interventions

Robotic balance rehabilitation with hunova® robotic platform DEVICE

The G-Hun will perform robotic balance treatment with the hunova® robotic platform lasting 30 minutes per session, 2 times a week for 5 weeks, in addition to the services provided in their clinical pathway.

Experimental Group (G-Hun)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years;
• Diagnosis of AN, BN, DAI according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-5 Edition, DSM-5)
• Ability to walk independently or with little assistance;
• Ability to understand and sign informed consent.

You may not qualify if:

• Current or past cognitive disorders (mental retardation) with Mini Mental State Evaluation (MMSE) values ≤ 26 ;
• Severe clinical conditions (head trauma, severe neurological and cardiac diseases and vascular disorders, oncological diseases);
• Substance use disorders;
• Unstabilized major psychiatric disorders (e.g., manic episode, acute psychotic episode, etc.);
• Taking medications that alter cardiac activity;
• Orthopedic or postural problems;
• Presence of plantar ulcers;
• Partial or total amputation of foot segments;
• Inability to provide informed consent.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Roma, 00168, Italy

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Anorexia Nervosa; Bulimia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Silvia Giovannini, MD, PhD

CONTACT

+390630154382; silvia.giovannini@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)