Technological Balance Rehabilitation in Feed and Eating Disorders

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Proprioception [Срок оценки: Change from Baseline proprioception at 5 weeks]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Идентификаторы

NCT: NCT06641973 · 6656

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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