Postural BalanceNCT06066047
Effect of Attentional Touch in Stabilometric Assessments
A study testing TOUCH ATTENTIVE TREATMENT and AUDITORY ATTENTIVE TREATMENT in people with Postural Balance, run by Accademia Italiana Medicina Osteopatica at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- TOUCH ATTENTIVE TREATMENT and AUDITORY ATTENTIVE TREATMENT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aymptomatics
Who cannot join
- serious illnesses
- balance disorders
- recent trauma (within 2 years) to the lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postural Balance
- Being tested
- TOUCH ATTENTIVE TREATMENT, AUDITORY ATTENTIVE TREATMENT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOUCH ATTENTIVE TREATMENTOther
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 TREATMENTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TOUCH ATTENTIVE TREATMENT | Experimental | 15 minutes of osteopathic treatment with operator's touch attention Receives: Other: TOUCH ATTENTIVE TREATMENT |
| AUDITORY ATTENTIVE TREATMENT | Sham comparator | 15 minutes of osteopathic treatment with operator's auditory attention Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Sep 2023
- Primary completion20 Dec 2023
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accademia Italiana Medicina Osteopatica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066047
- Sponsor's protocol ID
- 003
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Term Effect of Attentional Touch on Sway Rate Variation of CoP in Asymptomatic Subjects: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06066047
- Acronym / sponsor ID
- 003
- Conditions
- Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Accademia Italiana Medicina OsteopaticaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TOUCH ATTENTIVE TREATMENT | Experimental | Other: TOUCH ATTENTIVE TREATMENT15 minutes of osteopathic treatment with operator's touch attention |
| AUDITORY ATTENTIVE TREATMENT | Sham comparator | Other: AUDITORY ATTENTIVE TREATMENT15 minutes of osteopathic treatment with operator's auditory attention |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aymptomatics
Key exclusion criteria (3 listed)
- serious illnesses
- balance disorders
- recent trauma (within 2 years) to the lower limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOUCH ATTENTIVE TREATMENT15-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. | Other | TOUCH ATTENTIVE TREATMENT |
| AUDITORY ATTENTIVE TREATMENT15-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. | Other | AUDITORY ATTENTIVE TREATMENT |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOUCH ATTENTIVE TREATMENT and AUDITORY ATTENTIVE TREATMENT in people with Postural Balance, run by Accademia Italiana Medicina Osteopatica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the velocity variation of the displacement of the centre of pressure (CoP). (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.