Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05899244
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2023-04-05
Brief Title:
Influence of Muscle Stretching and Neural Mobilizations on Lower Limbs Range of Motion in Asymptomatic Subjects
Sponsor:
University of Liege
Organization:
University of Liege
Study Overview
Official Title:
Determining the Most Efficient Techniques of Gain of Range of Motion in Function of the Type of Limitation in Asymptomatic Subjects
Status:
COMPLETED
Status Verified Date:
2023-10
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:
First this study aims to use the straight leg raising test SLR and the knee angle extension test KEA test associated to a structural differentiation to determine the limitation of the lower limb muscular or nervous in asymptomatic subjects
Second this study will try to determine the most efficient exercice to increase range of motion of the lower limb in function of subjects limitation type muscular nervous using neural mobilization sliders or tensioners and muscle stretching
Two groups will be constituted for each test SLR and KEA based on the limitation defined during the test
Group 1 Muscle limitation Group 2 Neural limitation
Each group will be subdivided in four subgroups depending on the intervention participants will receive
subgroup 1 Muscle stretching group
subgroup 2 Neural tensioner group
subgroup 3 Neural slider group
subgroup 4 Control group
Participants from groups 12 and 3 will be asked to do an exercice every day during 31 days independently of their subgroup allocation
Participants from group 1 will perform a muscle stretching technique during 20 second twice a day
Participants from group 2 will do 10 repetitions of tensioner twice a day Participants from group 3 will do 10 repetitions of a slider twice a day
Subgroup comparisons of the evolution of the range of motion during SLR and KEA before and after the month of exercice will determine which technique is the most efficient for a specific type of limitation
Second this study will try to determine the most efficient exercice to increase range of motion of the lower limb in function of subjects limitation type muscular nervous using neural mobilization sliders or tensioners and muscle stretching
Two groups will be constituted for each test SLR and KEA based on the limitation defined during the test
Group 1 Muscle limitation Group 2 Neural limitation
Each group will be subdivided in four subgroups depending on the intervention participants will receive
subgroup 1 Muscle stretching group
subgroup 2 Neural tensioner group
subgroup 3 Neural slider group
subgroup 4 Control group
Participants from groups 12 and 3 will be asked to do an exercice every day during 31 days independently of their subgroup allocation
Participants from group 1 will perform a muscle stretching technique during 20 second twice a day
Participants from group 2 will do 10 repetitions of tensioner twice a day Participants from group 3 will do 10 repetitions of a slider twice a day
Subgroup comparisons of the evolution of the range of motion during SLR and KEA before and after the month of exercice will determine which technique is the most efficient for a specific type of limitation
Detailed Description:
Objectives
First this study aims to use the straight leg raising test SLR and the knee angle extension test KEA test associated to a structural differentiation to determine the limitation of the lower limb muscular or nervous in asymptomatic subjects
Second this study will try to determine the most efficient exercice to increase range of motion of the lower limb in function of subjects limitation type muscular nervous using neural mobilization sliders or tensioners and muscle stretching
Procedures
All the participants will attend two assessment sessions ie at baseline and after 31 days expect for participants allocate in the control group who will be also tested 48 to 72 hours after the first evaluation in order to determine the testretest reliability of the structural differentiation
Baseline session
During the baseline session demographics data will be collected age gender height and weight and a check for exclusions criteria will be conducted The identification of the dominant lower limb will then be performed by asking participants to shoot on a ball
The Identification of the limitation
The leg to be tested will be the dominant one in half of the population while the other half will have the non-dominant leg tested In order to standardize the assessments participants will be placed supine with the cervical spine in neutral position and with the upper part of head at the edge of the examination table Table with a moveable head set with both hands placed under the lumbar spine Furthermore a belt will be place to fix the pelvis to the examination table at the level of the anterior superior iliac spine
The SLR and the KEA tests will then be performed For standardization purposes the same sequence of testing will be used at each session for the same participant first SLR and second KEA or conversely but sequences of tests will be used alternatively between participants to avoid methodological bias Participants will be asked to say stop when a discomfort appears at the posterior part of the tight the calf the knee the buttock or in the foot
For the SLR the investigator will induce a hip flexion movement while maintaining the knee in extension with one hand placed on the distal anterior part of the tight and with the other hand located on the posterior distal part of the leg 9
For the KEA a labrique inclinometer will be placed on the anterior part of the tight allowing the investigator to control that a 90 of hip flexion is maintained while he will passively induce a knee extension
A second investigator will evaluate the hip and knee range of motion during the SLR and KEA respectively with an electronical inclinometer using the more proximal part of the tibial tuberosity as a marker for the device placement
While maintaining the ipsilateral SLR or KEA a structural differentiation SD will be used to identify the structure related to patient discomfort In order to do the SD 2 stages will be conducted first a third investigator will passively induce a flexion of the thoracic spine using the movable cranial part of the table and will manually move the cervical spine in flexion The participant will then be invited to define if the discomfort in the limb tested is modified using the following predefined descriptors increase decrease not changed different location of the symptoms or a combination of these In the second stage the third investigator will induce a passive extension of the thoracic and cervical spine and participants will be asked to report any potential changes of the lower limbs discomfort using the same descriptors as mentioned previously
Interpretation of the tests and group allocation
If both stages of the SD did not change the lower limb discomfort a muscle limitation will be suspected Nervous structures will be suspected to be the limiting factor if the discomfort was increased during the flexion part of the SD and decreased during the extension part
Thereby participants will be divided in two groups the Nerve groupwill included the participants in whom nervous structures were suspected to be the limiting factor after SD the Muscle group will include participant for whom a muscle limitation was suspected
Exercise allocation will be done by another investigator in a separate room In each groups Nerve or Muscle participants will be randomized in one of the four following subrgroups
subgroup 1 Muscle stretching group
subgroup 2 Neural tensioner group
subgroup 3 Neural slider group
subgroup 4 Control group
Participants from groups 12 and 3 will be asked to do an exercice every day during 31 days independently of their subgroup allocation
Participants from group 1 will perform a muscle stretching technique during 20 second twice a day
Participants from group 2 will do 10 repetitions of tensioner twice a day Participants from group 3 will do 10 repetitions of a slider twice a day
Subgroup comparisons of the evolution of the range of motion during SLR and KEA before and after the month of exercice will determine which technique is the most efficient for a specific type of limitation
First this study aims to use the straight leg raising test SLR and the knee angle extension test KEA test associated to a structural differentiation to determine the limitation of the lower limb muscular or nervous in asymptomatic subjects
Second this study will try to determine the most efficient exercice to increase range of motion of the lower limb in function of subjects limitation type muscular nervous using neural mobilization sliders or tensioners and muscle stretching
Procedures
All the participants will attend two assessment sessions ie at baseline and after 31 days expect for participants allocate in the control group who will be also tested 48 to 72 hours after the first evaluation in order to determine the testretest reliability of the structural differentiation
Baseline session
During the baseline session demographics data will be collected age gender height and weight and a check for exclusions criteria will be conducted The identification of the dominant lower limb will then be performed by asking participants to shoot on a ball
The Identification of the limitation
The leg to be tested will be the dominant one in half of the population while the other half will have the non-dominant leg tested In order to standardize the assessments participants will be placed supine with the cervical spine in neutral position and with the upper part of head at the edge of the examination table Table with a moveable head set with both hands placed under the lumbar spine Furthermore a belt will be place to fix the pelvis to the examination table at the level of the anterior superior iliac spine
The SLR and the KEA tests will then be performed For standardization purposes the same sequence of testing will be used at each session for the same participant first SLR and second KEA or conversely but sequences of tests will be used alternatively between participants to avoid methodological bias Participants will be asked to say stop when a discomfort appears at the posterior part of the tight the calf the knee the buttock or in the foot
For the SLR the investigator will induce a hip flexion movement while maintaining the knee in extension with one hand placed on the distal anterior part of the tight and with the other hand located on the posterior distal part of the leg 9
For the KEA a labrique inclinometer will be placed on the anterior part of the tight allowing the investigator to control that a 90 of hip flexion is maintained while he will passively induce a knee extension
A second investigator will evaluate the hip and knee range of motion during the SLR and KEA respectively with an electronical inclinometer using the more proximal part of the tibial tuberosity as a marker for the device placement
While maintaining the ipsilateral SLR or KEA a structural differentiation SD will be used to identify the structure related to patient discomfort In order to do the SD 2 stages will be conducted first a third investigator will passively induce a flexion of the thoracic spine using the movable cranial part of the table and will manually move the cervical spine in flexion The participant will then be invited to define if the discomfort in the limb tested is modified using the following predefined descriptors increase decrease not changed different location of the symptoms or a combination of these In the second stage the third investigator will induce a passive extension of the thoracic and cervical spine and participants will be asked to report any potential changes of the lower limbs discomfort using the same descriptors as mentioned previously
Interpretation of the tests and group allocation
If both stages of the SD did not change the lower limb discomfort a muscle limitation will be suspected Nervous structures will be suspected to be the limiting factor if the discomfort was increased during the flexion part of the SD and decreased during the extension part
Thereby participants will be divided in two groups the Nerve groupwill included the participants in whom nervous structures were suspected to be the limiting factor after SD the Muscle group will include participant for whom a muscle limitation was suspected
Exercise allocation will be done by another investigator in a separate room In each groups Nerve or Muscle participants will be randomized in one of the four following subrgroups
subgroup 1 Muscle stretching group
subgroup 2 Neural tensioner group
subgroup 3 Neural slider group
subgroup 4 Control group
Participants from groups 12 and 3 will be asked to do an exercice every day during 31 days independently of their subgroup allocation
Participants from group 1 will perform a muscle stretching technique during 20 second twice a day
Participants from group 2 will do 10 repetitions of tensioner twice a day Participants from group 3 will do 10 repetitions of a slider twice a day
Subgroup comparisons of the evolution of the range of motion during SLR and KEA before and after the month of exercice will determine which technique is the most efficient for a specific type of limitation
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?:
None
Is an FDA AA801 Violation?:
None