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Clinical Trials/NCT06641973
NCT06641973
Not Yet Recruiting
N/A

Technological Balance and Gait Rehabilitation in Patients With Feed and Eating Disorders: Effects on Functional, Motor, and Cognitive Outcomes

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 site in 1 country72 target enrollmentSeptember 1, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Feeding Disorders
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Enrollment
72
Locations
1
Primary Endpoint
Proprioception
Status
Not Yet Recruiting
Last Updated
9 months ago

Overview

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.

Detailed Description

Some authors have pointed out that altered sensitivity may be related to impaired balance and/or postural control in obese patients : in fact, less accurate proprioceptive information is more detrimental to postural stability, especially in more demanding tasks . To prevent balance problems due to impaired proprioception, some authors suggest sensory training . However, to date, there are no works investigating the role of proprioceptive rehabilitation in patients with FED. The purpose of this study is to evaluate the effects of technological rehabilitation using a robotic platform (hunova® Movendo Technology srl, Genoa, IT) on motor performance, cognitive performance, mood, fatigue, and quality of life. Patients meeting the inclusion criteria will be recruited from the UOC Clinical and Emergency Psychiatry and the Outpatient Clinics of the Clinical Psychiatry and Addiction Area, and will be evaluated and treated at the UOS Post-Acute Rehabilitation, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Patients will be divided into 2 groups by randomization, as specified below. One group (G-Hun), will perform the robotic balance treatment with the robotic platform (hunova®) lasting 30 minutes per session, 2 times a week for 5 weeks, in addition to the services provided by their clinical pathway; while the other group (G-Con), will perform the services provided by the clinical pathway.

Registry
clinicaltrials.gov
Start Date
September 1, 2025
End Date
September 1, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

GIOVANNINI SILVIA

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Proprioception

Time Frame: Change from Baseline proprioception at 5 weeks

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

Secondary Outcomes

  • 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)
  • Trial Making Test (TMT)(Change from Baseline TMT at 5 weeks)
  • Symbol Digit Modalities Test (SDMT)(Change from Baseline SDMT at 5 weeks)
  • Stroop Colour Word Test (SCWT)(Change from Baseline SCWT at 5 weeks)
  • Eating Disorder Inventory (EDI-3)(Change from Baseline EDI-3 at 5 weeks)
  • Eating Disorder Examination Questionnaire 7.0 (EDE-Q)(Change from Baseline EDE-Q at 5 weeks)
  • Binge-Eating Scale (BES)(Change from Baseline BES at 5 weeks)
  • Heartbeat Perception Task (HPT)(Change from Baseline HPT at 5 weeks)
  • Depression Anxiety Stress Scales Short Version (DASS-21)(Change from Baseline DASS-21 at 5 weeks)
  • Difficulties in Emotion Regulation Scale-2 (DERS)(Change from Baseline DERS at 5 weeks)
  • Body Uneasiness Test (BUT)(Change from Baseline BUT at 5 weeks)
  • Toronto Alexithymia Scale 20-item version (TAS-20)(Change from Baseline TAS-20 at 5 weeks)
  • Modified Fatigue Impact Scale (MFIS)(Change from Baseline MFIS at 5 weeks)
  • EuroQoL- 5D (EQ-5D)(Change from Baseline EQ-5D at 5 weeks)
  • Silver Index (SI)(Change from Baseline SI at 5 weeks)

Study Sites (1)

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