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
Status
Completed
Conditions
Intervention / Treatment
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 Locations
-
-
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Mantova, Italy, 46100
- Studio osteopatico Bettoni
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-
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.
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.
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 (033)
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.