Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474585
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-12
Brief Title:
Clinical Effects of the Medial Longitudinal Arch Slope of a Plantar Orthosis
Sponsor:
Universidad Complutense de Madrid
Organization:
Universidad Complutense de Madrid
Study Overview
Official Title:
Effects of the Medial Longitudinal Slope on Clinical Parameters and Acceleration Impacts During Gait
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this clinical trial is to compare the effects of the geometry of the medial longitudinal arch MLA of the insole on acceleration impacts during gait measured using an accelerometry system in patients with pain related to the presence of a pronated foot morphotype The main questions it aims to answer are
Is the slope of the medial longitudinal arch of the orthotic treatment a factor that reduces the peak tibial accelerometry in a symptomatic foot with a medially oriented subtalar joint axis To assess the predictive effect of changes in acceleration impacts on the patients painful symptoms
The researchers will compare the MLA of the insole taken in a standing position with the MLA of the insole taken in a sitting position the treatment applied in routine clinical practice to evaluate if changing the slope of the MLA generates changes in the tibial acceleration impacts
The participants
Must use the insoles to carry out their daily activities except for sleeping or bathing
The first review of the orthotic treatment will be conducted 3 months after the treatment initiation
Is the slope of the medial longitudinal arch of the orthotic treatment a factor that reduces the peak tibial accelerometry in a symptomatic foot with a medially oriented subtalar joint axis To assess the predictive effect of changes in acceleration impacts on the patients painful symptoms
The researchers will compare the MLA of the insole taken in a standing position with the MLA of the insole taken in a sitting position the treatment applied in routine clinical practice to evaluate if changing the slope of the MLA generates changes in the tibial acceleration impacts
The participants
Must use the insoles to carry out their daily activities except for sleeping or bathing
The first review of the orthotic treatment will be conducted 3 months after the treatment initiation
Detailed Description:
Study Population The study population will consist of patients treated from June 2024 onwards at the Pathology and Orthopedics Service of the University Clinic of Podiatry at Complutense University of Madrid All participants will be informed beforehand about the characteristics objectives and methodology of the present study and must consent by signing the informed consent form which complies with the regulatory legislation under the Organic Law on Data Protection and guarantee of digital rights 32018 of December 5 and Law 412002 of November 14 which regulates the patients autonomy and rights and obligations in terms of information and clinical documentation Organic Law 32018 recognizes a series of rights for citizens such as the right of access rectification cancellation and opposition to their personal data the right to limit the treatment of incorrect data request a copy or transfer the data provided for the study to a third party portability to the extent that they are applicable
Sample Size A sample size is estimated for the comparison of two independent proportions at a 5 significance level an 80 statistical power and a two-tailed test Since no published study has evaluated exactly the angulation in both sitting and standing positions under the same conditions reference values are not precisely known However it is estimated that the main outcome variable peak acceleration will behave similarly There is a threshold for this variable at 8 g such that a peak above this is a risk factor for developing lower limb pathology In our study it is expected that only 5 of patients in group A will have a peak above 8 g while 30 of patients in group B will have a peak above 8 g Considering these factors and anticipating a 15 possible dropout rate a minimum sample size of 37 patients per group is needed to achieve the main objective totaling 74 patients
Analyzed Variables and Data Collection Procedures Patient data recording will begin on the first consultation day after conducting the relevant screening and fulfilling the established inclusion and exclusion criteria All data will be collected in a data collection notebook with each patient assigned an identification code to safeguard compliance with the Organic Law on Data Protection and guarantee of digital rights 32018 of December 5 and Law 412002 of November 14 which regulates the patients autonomy and rights and obligations in terms of information and clinical documentation
Dependent Variables
Outcome Variables
Primary Variable Maximum tibial acceleration g Continuous quantitative variable ms²
Secondary Variables
Maximum head acceleration g Continuous quantitative variable ms² Magnitude of head acceleration g Continuous quantitative variable ms² Head acceleration ratio 38-70 gs Continuous quantitative variable ms² Magnitude of tibial acceleration g Continuous quantitative variable ms² Tibial acceleration ratio 30-70 gs Continuous quantitative variable ms²
Impact attenuation Continuous quantitative variable ms² Step length cm Continuous quantitative variable cm Stride frequency Hz Continuous quantitative variable Hz Independent Variables Treatment Variables Demographic Variables - Covariates Clinical Variables Variables related to the wear of the orthotic treatment Study Planning Patient Recruitment Start June 2024 Estimated End of Patient Recruitment December 2024 Treatments Treatment A A plantar orthosis made of 45 mm polypropylene with BIO at the necessary degrees according to the patients biomechanical characteristics MLA that replicates the geometry and slope of the MLA in the sitting position unloaded Duration of treatment 12 weeks
Treatment B A plantar orthosis made of 45 mm polypropylene with BIO and the MLA taken from the patient replicates the geometry and slope of the MLA in the standing position loaded Duration 12 weeks
Patient Visit Planning VISIT 1 Inclusion in the study VISIT 2 Treatment delivery Acceleration data will be recorded using an Xsens DOR accelerometry system Xsens Enschede Netherlands total mass 109 g dimensions 36x30x11 mm range 16 g consisting of 3 triaxial accelerometers Two accelerometers will be placed on the anteromedial surface of the distal end of both tibias 3 cm superior to the medial malleolus where the first uniformflat surface is present with the vertical axis of the accelerometer parallel to the tibial vertical axis the third accelerometer will be placed on the forehead with the tibial vertical axis and the third accelerometer will be placed on the forehead with the accelerometers vertical axis perpendicular to the ground All accelerometers will be placed by a single researcher ASR Patients will wear sports clothing shorts and neutral Reebok Classics sneakers Before starting the test the patient will walk freely around the room for 5 minutes to get used to the shoes andor orthosis Then the patient will be instructed to walk at a comfortable and safe speed along a straight 12 m corridor performing a total of 10 series Accelerometry data will be recorded during the central 8 meters with 2 meters at the start and 2 meters at the end designated as acceleration and deceleration zones respectively to avoid their effects The speed of each series will be recorded using a photo-cell system Chronojump Boscosystem but it will not be controlled to avoid altering the natural gait pattern The average speed of all series for each participant will be calculated and those not within 5 of each participants average speed will be discarded to minimize the effect of gait speed on acceleration impacts
After this second visit orthoses A and B will be distributed randomly dividing the sample into two equal halves so that patients will use the assigned orthosis daily for 12 weeks
VISIT 3 12 weeks after starting the treatment
Sample Size A sample size is estimated for the comparison of two independent proportions at a 5 significance level an 80 statistical power and a two-tailed test Since no published study has evaluated exactly the angulation in both sitting and standing positions under the same conditions reference values are not precisely known However it is estimated that the main outcome variable peak acceleration will behave similarly There is a threshold for this variable at 8 g such that a peak above this is a risk factor for developing lower limb pathology In our study it is expected that only 5 of patients in group A will have a peak above 8 g while 30 of patients in group B will have a peak above 8 g Considering these factors and anticipating a 15 possible dropout rate a minimum sample size of 37 patients per group is needed to achieve the main objective totaling 74 patients
Analyzed Variables and Data Collection Procedures Patient data recording will begin on the first consultation day after conducting the relevant screening and fulfilling the established inclusion and exclusion criteria All data will be collected in a data collection notebook with each patient assigned an identification code to safeguard compliance with the Organic Law on Data Protection and guarantee of digital rights 32018 of December 5 and Law 412002 of November 14 which regulates the patients autonomy and rights and obligations in terms of information and clinical documentation
Dependent Variables
Outcome Variables
Primary Variable Maximum tibial acceleration g Continuous quantitative variable ms²
Secondary Variables
Maximum head acceleration g Continuous quantitative variable ms² Magnitude of head acceleration g Continuous quantitative variable ms² Head acceleration ratio 38-70 gs Continuous quantitative variable ms² Magnitude of tibial acceleration g Continuous quantitative variable ms² Tibial acceleration ratio 30-70 gs Continuous quantitative variable ms²
Impact attenuation Continuous quantitative variable ms² Step length cm Continuous quantitative variable cm Stride frequency Hz Continuous quantitative variable Hz Independent Variables Treatment Variables Demographic Variables - Covariates Clinical Variables Variables related to the wear of the orthotic treatment Study Planning Patient Recruitment Start June 2024 Estimated End of Patient Recruitment December 2024 Treatments Treatment A A plantar orthosis made of 45 mm polypropylene with BIO at the necessary degrees according to the patients biomechanical characteristics MLA that replicates the geometry and slope of the MLA in the sitting position unloaded Duration of treatment 12 weeks
Treatment B A plantar orthosis made of 45 mm polypropylene with BIO and the MLA taken from the patient replicates the geometry and slope of the MLA in the standing position loaded Duration 12 weeks
Patient Visit Planning VISIT 1 Inclusion in the study VISIT 2 Treatment delivery Acceleration data will be recorded using an Xsens DOR accelerometry system Xsens Enschede Netherlands total mass 109 g dimensions 36x30x11 mm range 16 g consisting of 3 triaxial accelerometers Two accelerometers will be placed on the anteromedial surface of the distal end of both tibias 3 cm superior to the medial malleolus where the first uniformflat surface is present with the vertical axis of the accelerometer parallel to the tibial vertical axis the third accelerometer will be placed on the forehead with the tibial vertical axis and the third accelerometer will be placed on the forehead with the accelerometers vertical axis perpendicular to the ground All accelerometers will be placed by a single researcher ASR Patients will wear sports clothing shorts and neutral Reebok Classics sneakers Before starting the test the patient will walk freely around the room for 5 minutes to get used to the shoes andor orthosis Then the patient will be instructed to walk at a comfortable and safe speed along a straight 12 m corridor performing a total of 10 series Accelerometry data will be recorded during the central 8 meters with 2 meters at the start and 2 meters at the end designated as acceleration and deceleration zones respectively to avoid their effects The speed of each series will be recorded using a photo-cell system Chronojump Boscosystem but it will not be controlled to avoid altering the natural gait pattern The average speed of all series for each participant will be calculated and those not within 5 of each participants average speed will be discarded to minimize the effect of gait speed on acceleration impacts
After this second visit orthoses A and B will be distributed randomly dividing the sample into two equal halves so that patients will use the assigned orthosis daily for 12 weeks
VISIT 3 12 weeks after starting the treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None