Clinical trial NCT06641973: Technological Balance Rehabilitation in Feed and Eating Disorders
Official title: Technological Balance and Gait Rehabilitation in Patients With Feed and Eating Disorders: Effects on Functional, Motor, and Cognitive Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Feeding Disorders
Anorexia Nervosa
Bulimia Nervosa
Keywords: Rehabilitation
Feeding Disorders
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proprioception
timeFrame: Change from Baseline proprioception at 5 weeks
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: Change from Baseline BBS at 5 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: Change from Baseline TUG at 5 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from Baseline SPPB at 5 weeks
measure: Timed-25 Foot Walk (T25FW)
timeFrame: Change from Baseline T25FW at 5 weeks
measure: Mental Deterioration battery (MDB)
timeFrame: Change from Baseline MDB at 5 weeks
measure: Trial Making Test (TMT)
timeFrame: Change from Baseline TMT at 5 weeks
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Change from Baseline SDMT at 5 weeks
measure: Stroop Colour Word Test (SCWT)
timeFrame: Change from Baseline SCWT at 5 weeks
measure: Eating Disorder Inventory (EDI-3)
timeFrame: Change from Baseline EDI-3 at 5 weeks
measure: Eating Disorder Examination Questionnaire 7.0 (EDE-Q)
timeFrame: Change from Baseline EDE-Q at 5 weeks
measure: Binge-Eating Scale (BES)
timeFrame: Change from Baseline BES at 5 weeks
measure: Heartbeat Perception Task (HPT)
timeFrame: Change from Baseline HPT at 5 weeks
measure: Depression Anxiety Stress Scales Short Version (DASS-21)
timeFrame: Change from Baseline DASS-21 at 5 weeks
measure: Difficulties in Emotion Regulation Scale-2 (DERS)
timeFrame: Change from Baseline DERS at 5 weeks
measure: Body Uneasiness Test (BUT)
timeFrame: Change from Baseline BUT at 5 weeks
measure: Toronto Alexithymia Scale 20-item version (TAS-20)
timeFrame: Change from Baseline TAS-20 at 5 weeks
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Change from Baseline MFIS at 5 weeks
measure: EuroQoL- 5D (EQ-5D)
timeFrame: Change from Baseline EQ-5D at 5 weeks
measure: Silver Index (SI)
timeFrame: Change from Baseline SI at 5 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
References: