Technological Balance Rehabilitation in Feed and Eating Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.);
Trial design
Design model
Parallel
Treatments tested in this trial
Robotic balance rehabilitation with hunova® robotic platform
DeviceThe 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Experimental Group (G-Hun)Experimental treatment 1 intervention
Group B: Control Group (G-Con)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Proprioception
Improved proprioception as assessed by reduction of Center of Pressure (COP) oscillations using the hunova robotic platform
Time frame
Change from Baseline proprioception at 5 weeksSecondary outcomes
1
Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Time frame
Change from Baseline BBS at 5 weeks2
Timed Up and Go Test (TUG)
The Timed Up and Go test (TUG) measures in seconds the time it takes a subject to rise from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down. The performance is rated on a scale of 1 to 5 (where 1 is normal and 5 is severely abnormal) according to the observer's perception of the patient's risk of falling. The timed part of the test records the mean time (in seconds) from initial getting up to re-seating. Patients are compared with the mean time of adults in their age group, 60 to 69, 70 to 79, and 80 to 99 years of age.
Time frame
Change from Baseline TUG at 5 weeks3
Short Physical Performance Battery (SPPB)
SPPB is an objective measurement instrument of balance, lower extremity strength, and functional capacity in older adults (\>65 years of age). Three domains, which include balance, usual or self-selected gait speed, and lower limb strength, are assessed by a three-stage balance test (feet side-by-side, semitandem, and tandem positions), a 3-m or 4-m gait speed test (time spent to walk the course), and a repetitive chair stand test (five times chair sit-to-stand test), respectively. A 0- to 12-point scale is used to score the sum of the three assessments with higher point values corresponding with greater levels of physical function and lower disability, whereas lower point values correspond with lower levels of physical function and higher disability, respectively.
Time frame
Change from Baseline SPPB at 5 weeks4
Timed-25 Foot Walk (T25FW)
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-foot walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.
Time frame
Change from Baseline T25FW at 5 weeksSponsors and contacts
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Source ClinicalTrials.gov
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