Effect of Attentional Touch in Stabilometric Assessments

NCT06066047 | Completed DMC

• 1 other identifier: 003
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postural Balance

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

TOUCH ATTENTIVE TREATMENT

EXPERIMENTAL

15 minutes of osteopathic treatment with operator's touch attention

Other: TOUCH ATTENTIVE TREATMENT

AUDITORY ATTENTIVE TREATMENT

SHAM COMPARATOR

15 minutes of osteopathic treatment with operator's auditory attention

Other: AUDITORY ATTENTIVE TREATMENT

CONTROL

NO INTERVENTION

The volunteers lay for 15 minutes in the same environment as the volunteers in the other two groups, without being touched in any way.

Interventions

TOUCH ATTENTIVE TREATMENT OTHER

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.

TOUCH ATTENTIVE TREATMENT

AUDITORY ATTENTIVE TREATMENT OTHER

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.

AUDITORY ATTENTIVE TREATMENT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aymptomatics

You may not qualify if:

• serious illnesses
• balance disorders
• recent trauma (within 2 years) to the lower limbs

Sponsors & Collaborators

• Accademia Italiana Medicina Osteopatica: lead

Study Sites (1)

Studio osteopatico Bettoni

Mantova, 46100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 4, 2023
• Study Start: September 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: January 20, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

IT (1)