Effect of Attentional Touch in Stabilometric Assessments

January 25, 2024 updated by: Accademia Italiana Medicina Osteopatica

Low Term Effect of Attentional Touch on Sway Rate Variation of CoP in Asymptomatic Subjects: a Randomized Clinical Trial.

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Mantova, Italy, 46100
        • Studio osteopatico Bettoni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

• aymptomatics

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TOUCH ATTENTIVE TREATMENT
15 minutes of osteopathic treatment with operator's touch attention

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.

Sham Comparator: AUDITORY ATTENTIVE TREATMENT
15 minutes of osteopathic treatment with operator's auditory attention

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.

No Intervention: CONTROL
The volunteers lay for 15 minutes in the same environment as the volunteers in the other two groups, without being touched in any way.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

January 20, 2024

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 30, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Estimated)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 003 (NuSkin International)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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