Viewing Study NCT06641973



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06641973
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-10-11

Brief Title: Technological Balance Rehabilitation in Feed and Eating Disorders
Sponsor: None
Organization: None

Study Overview

Official Title: Technological Balance and Gait Rehabilitation in Patients With Feed and Eating Disorders Effects on Functional Motor and Cognitive Outcomes
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ROAR-FED
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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None