- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05583760
Stabilometric and Baropodometric Evaluation After Osteopathic Scaphoid Tug Manipulation
February 7, 2023 updated by: SERGIO MONTERO NAVARRO, Cardenal Herrera University
Stabilometric and Baropodometric Evaluation of Osteopathic Scaphoid Tug Manipulation
This is a clinical, longitudinal, prospective and randomised study in which the subject will be assessed by stabilometric and baropodometric techniques on two occasions (before being subjected to the scaphoid tug manipulation for the experimental group or placebo technique in the case of the control group).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
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
-
-
Alicante
-
Elche, Alicante, Spain, 03204
- Sergio Montero Navarro
-
-
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
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects with right scaphoid external rotation dysfunction
Exclusion Criteria:
- Suffering from disorders that alter balance (tension headaches, vertigo, migraines...).
- Deformities, orthopaedic injuries or sequelae in the limbs or spine that may alter postural statics (valgus-varus, lower limb operations, lower limb dysmetries, scoliosis, etc.).
Pathologies or sequelae related to the postural sensors or disorders in the same:
- Uncorrected visual defects.
- Vestibular disorders.
- Uncorrected stomatological disorders.
- Sensory alterations in the foot sensor (Hypoaesthesia, Morton's neuroma, tarsal canal syndrome, etc.).
- Cutaneous alterations that influence the foot pick-up (papillomas, plantar warts, ingrown toenails, etc.).
- Ingestion of medication that alters the perception of stability.
- Having any contraindication to the scaphoid tug technique.
- Having carried out intense physical activity immediately prior to the study.
- Having received osteopathic treatment in the last month.
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Experimental: Osteopathic manipulation TUG for scaphoid bone
|
The sequence of execution of the scaphoid TUG technique shall be applied as follows.
Patient in the supine position.
The inner hand of the intervener makes contact with the pisiform through the hypothenar eminence and ulnar border of the hand over the scaphoid tubercle, the outer hand reinforces the contact.
The thumbs are directed to the sole of the patient's foot.
The parameters are sought by bringing the sole of the foot into eversion, thus bringing the scaphoid into internal rotation (the direction of correction).
In order to reduce the slack, the operator drops his body weight backwards while increasing the internal rotation parameter of the scaphoid.
The manipulation is performed by associating a rapid traction movement with an increase of the correction parameter towards the internal rotation of the scaphoid.
|
|
SHAM_COMPARATOR: Sham group: Sham osteopathic manipulation TUG for scaphoid bone
|
The intervention will be performed in the same way as the intervention group, without actually performing the TUG manipulation on the scaphoid bone, only placing it in tension.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
stabilometric measurements: oscillation about the X-axis
Time Frame: five minutes post-intervention
|
(mm)
|
five minutes post-intervention
|
|
stabilometric measurements: oscillation about the Y-axis
Time Frame: five minutes post-intervention
|
(mm)
|
five minutes post-intervention
|
|
stabilometric measurements: area of the ellipse
Time Frame: five minutes post-intervention
|
(cm2)
|
five minutes post-intervention
|
|
static baropodometric measurements: scan Foot bearing area
Time Frame: five minutes post-intervention
|
(cm2)
|
five minutes post-intervention
|
|
static baropodometric measurements: scan percentage of body load supported by each foot
Time Frame: five minutes post-intervention
|
five minutes post-intervention
|
|
|
static baropodometric measurements: scan point of maximum plantar pressure
Time Frame: five minutes post-intervention
|
(kg/cm2)
|
five minutes post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Latash ML, Krishnamoorthy V, Scholz JP, Zatsiorsky VM. Postural synergies and their development. Neural Plast. 2005;12(2-3):119-30; discussion 263-72. doi: 10.1155/NP.2005.119.
- Zhang Y, Kiemel T, Jeka J. The influence of sensory information on two-component coordination during quiet stance. Gait Posture. 2007 Jul;26(2):263-71. doi: 10.1016/j.gaitpost.2006.09.007. Epub 2006 Oct 13.
- Myklebust JB, Prieto T, Myklebust B. Evaluation of nonlinear dynamics in postural steadiness time series. Ann Biomed Eng. 1995 Nov-Dec;23(6):711-9. doi: 10.1007/BF02584470.
- Hessert MJ, Vyas M, Leach J, Hu K, Lipsitz LA, Novak V. Foot pressure distribution during walking in young and old adults. BMC Geriatr. 2005 May 19;5:8. doi: 10.1186/1471-2318-5-8.
- Van Buskirk RL. Nociceptive reflexes and the somatic dysfunction: a model. J Am Osteopath Assoc. 1990 Sep;90(9):792-4, 797-809.
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)
October 18, 2022
Primary Completion (ACTUAL)
October 18, 2022
Study Completion (ACTUAL)
February 7, 2023
Study Registration Dates
First Submitted
October 10, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (ACTUAL)
October 18, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CEEI22/322
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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