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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06066047
Other study ID # 003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date January 20, 2024

Study information

Verified date January 2024
Source Accademia Italiana Medicina Osteopatica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Postural balance has been studied in the literature and ideal body mass distribution has been shown to provide stability to the body in an upright position. The use of stabilometry to assess posture is a standard in clinical practice and medical research. In the literature we find osteopathic treatment evaluated with stabilometry in specific pathological conditions. We will experiment on asymptomatic volunteers how attentive touch is effective compared to non-attentive touch and compared to an untreated group by measuring specific parameters that indicate postural balance.


Description:

Stabilometry measurements will be taken on asymptomatic volunteers before and after several specific treatments, in particular to measure whether the variance in sway speed is reduced after the treatments. The effect of attentional versus non-attentional touch will be compared in the other two groups, in addition to a control group that receives no treatment.


Recruitment information / eligibility

Status Completed
Enrollment 210
Est. completion date January 20, 2024
Est. primary completion date December 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: • aymptomatics Exclusion Criteria: - serious illnesses - balance disorders - recent trauma (within 2 years) to the lower limbs

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TOUCH ATTENTIVE TREATMENT
15-minute treatment using constant touch (0.20 N, approx. 20 grams) developed after training with visual feedback. 5 minutes bilateral touch on external malleolus 5 minutes longitudinal occipital front grip for reciprocal tension membrane movement and Sutherland's fulcrum 5 minutes bilateral touch on acromion, for midline, centring diaphragms Throughout the treatment, the practitioner maintained a focused attention on touch by voluntarily and constantly directing attention to the sensation/perception of the hands, perceiving texture, density, temperature, reactivity and motility of the tissue.
AUDITORY ATTENTIVE TREATMENT
15-minute treatment using constant touch (0.20 N, approx. 20 grams) developed after training with visual feedback. 5 minutes bilateral touch on external malleolus 5 minutes longitudinal occipital front grip for reciprocal tension membrane movement and Sutherland's fulcrum 5 minutes bilateral touch on acromion, for midline, centring diaphragms During the treatment, the operator's attention was focused on acoustic signals delivered through earphones. The beeps were delivered at random intervals between 0.5 and 2.0 seconds. The operator had to count the number of acoustic signals produced during the treatment period.

Locations

Country Name City State
Italy Studio osteopatico Bettoni Mantova

Sponsors (1)

Lead Sponsor Collaborator
Accademia Italiana Medicina Osteopatica

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary the velocity variation of the displacement of the centre of pressure (CoP). The variable is measured with a stabilometric scale (Cyber Sabots) by sampling the signal at 40 Hz. baseline
Primary the velocity variation of the displacement of the centre of pressure (CoP). The variable is measured with a stabilometric scale (Cyber Sabots) by sampling the signal at 40 Hz. 30 minutes
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