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

Overview

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.

Interventions

• Device Robotic balance rehabilitation with hunova® robotic platform
  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.

Primary outcome measures

• Proprioception [Time frame: Change from Baseline proprioception at 5 weeks]

Secondary outcome measures (12)

• Berg Balance Scale (BBS) [Time frame: Change from Baseline BBS at 5 weeks]
• Timed Up and Go Test (TUG) [Time frame: Change from Baseline TUG at 5 weeks]
• Short Physical Performance Battery (SPPB) [Time frame: Change from Baseline SPPB at 5 weeks]
• Timed-25 Foot Walk (T25FW) [Time frame: Change from Baseline T25FW at 5 weeks]
• Mental Deterioration battery (MDB) [Time frame: Change from Baseline MDB at 5 weeks]
• Trial Making Test (TMT) [Time frame: Change from Baseline TMT at 5 weeks]
• Symbol Digit Modalities Test (SDMT) [Time frame: Change from Baseline SDMT at 5 weeks]
• Stroop Colour Word Test (SCWT) [Time frame: Change from Baseline SCWT at 5 weeks]
• Eating Disorder Inventory (EDI-3) [Time frame: Change from Baseline EDI-3 at 5 weeks]
• Eating Disorder Examination Questionnaire 7.0 (EDE-Q) [Time frame: Change from Baseline EDE-Q at 5 weeks]
• Binge-Eating Scale (BES) [Time frame: Change from Baseline BES at 5 weeks]
• Heartbeat Perception Task (HPT) [Time frame: Change from Baseline HPT at 5 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Identifiers

NCT: NCT06641973 · 6656

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗