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Asymptomatic ConditionNCT05899244

Influence of Muscle Stretching and Neural Mobilizations on Lower Limbs Range of Motion in Asymptomatic Subjects.

A study testing muscle streching exercice, Slider and Tensioner in people with Asymptomatic Condition, run by University of Liege at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Asymptomatic Condition
What is being tested?
muscle streching exercice, Slider and Tensioner
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteBelgium
Study dates
15 Jun 2023to 4 Oct 2023
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults
  • Asymptomatic subject

Who cannot join

  • Mutiple Sclerosis
  • diabetis
  • Neuropathy
  • Stroke
  • Lumbar pain during the last 6 month
  • Lumbosacral radicular pain
Show all 11Show fewer
  • Meningitis
  • Sequelae of hamstring, gluteal or sural triceps tear
  • Sequelae of Achilles tendon section
  • Guillain-Barré Syndrom
  • hip and Knee replacement

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • UNiversity of liege

    Liège, Liege, 4000

Other trials in Belgium

About this study

Official title: Determining the Most Efficient Techniques of Gain of Range of Motion in Function of the Type of Limitation in Asymptomatic Subjects.

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.

Read more

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 1,2 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.

Read the 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 i.e., 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 test/retest 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 group"will 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 1,2 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.

Being tested
muscle streching exercice, Slider, Tensioner
Keywords
Straight leg raising test, Knee extension angle, Neural mobilization, Muscle Stretching, Asympotmatic subject
Medical subject headings
Asymptomatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • muscle streching exerciceOther

    For this exercice the participant will have to place the foot of the stretched leg on a step while maintaining his knee in extension.

    From this starting position the patient will have to do a pelvic anterior tilt while keeping is back straight and his gaze horizontal until the movement induce a feeling of stretching in the posterior part of the thigh.

  • SliderOther

    Also called neural sliding mobilization

    In order to define the starting position for a slider, the participant will be positioned in lateral decubitus with the knee extended and will perform a hip flexion until a sensation of pain or stretching feeling appears on the posterior part of the thigh or of the knee. If the hip flexion does not induce a stretching sensation or pain, a dorsal ankle flexion is added. Once this position is defined the patient slightly reduces the amount of hip flexion until the stretching/pain sensation disappears.

    From this starting position, to perform the slider: the subject performs a hip flexion movement and simultaneously a cervical extension movement, this corresponds to the outward movement. For the return movement the patient performs a hip extension and at the same time a cervical flexion. The slider technique must be pain free.

  • TensionerOther

    Also called neural tensioning mobilization

    The participant will be positioned in lateral decubitus with the knee extended and the hip, the cervical, thoracic and lumbar spine placed in neutral position.

    For the outward movement, the participant will perform a hip flexion associated with a simultaneous movement of cervical extension until a sensation of pain or a stretching feeling appears on the posterior part of the thigh or of the knee.If this combined movements do not induce a stretching sensation or pain, a dorsal flexion of the ankle is added.

    For the return movement, the participant will realize a hip extension simultaneously associated to a movement of extension of the cervical spine. If the dorsal flexion of the ankle was used during the outward movement, a movement plantar flexion of the ankle must be used in association to the movement of hip extension.

Study groups in NCT05899244
Study groupRoleWhat they receive
Muscle limitation subgroup receiving muscle stretching exerciceExperimentalThis subgroup of participants will have to perform 2 muscle stretching exercices every day during a month and to report the frequency of realisation on a smartphone or a web application.
Receives: Other: muscle streching exercice
Muscle limitation subgroup receiving a slider exerciceExperimentalThis subgroup of participants will have to perform two series of ten repetitions of a slider exercice every day during a month and to report the frequency of realisation on a smartphone or a web application.
Receives: Other: Slider
Muscle limitation subgroup receiving a tensioner exerciceExperimentalThis subgroup of participants will have to perform two series of ten repetitions of a tensioner exercice every day during a month and to report the frequency of realisation on a smartphone or a web application.
Receives: Other: Tensioner
Neural limitation subgroup receiving a muscle stretching exerciceExperimentalThis subgroup of participants will have to perform 2 muscle stretching exercices every day during a month and to report the frequency of realisation on a smartphone or a web application.
Receives: Other: muscle streching exercice
Neural limitation subgroup receiving a slider exerciceExperimentalThis subgroup of participants will have to perform two series of ten repetitions of a slider exercice every day during a month and to report the frequency of realisation on a smartphone or a web application.
Receives: Other: Slider
Neural limitation subgroup receiving a tensioner exerciceExperimentalThis subgroup of participants will have to perform two series of ten repetitions of a tensioner exercice every day during a month and to report the frequency of realisation on a smartphone or a web application.
Receives: Other: Tensioner
Neural limitation Control subgroupNo interventionParticipants in this subgroup will not receive an intervention.
Muscle limitation Control subgroupNo interventionParticipants in this subgroup will not receive an intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of the limitation type during the Knee extension angle test (KEA) after 31 days

    This outcome will be definfed as a muscle limitation or as a nerve limitation using the structural differentiation.

    Measured: After 31 days

  2. Change of Knee extension range of motion during KEA after 31 days

    This outcome corresponds to the angle of Knee extension mesured during the KEA which induced a discomfort or an unpleasant feeling at the posterior part of the buttock, the thigh, the leg or in the foot reported by the participant.

    An electronical inclinometer will be used for the measurement of this angle, placed on the tibial bone using the anterior tibial tuberosity as a reference point.

    Measured: After 31 days

  3. Change of limitation type of during the Straight leg raising test (SLR) after 31 days

    This outcome will be definfed as a muscle limitation or as a nerve limitation using the structural differentiation.

    Measured: After 31 days

  4. Change of Hip flexion range of motion during the Straight leg raising test after 31 days

    This outcome corresponds to angle of hip flexion measured during SLR test which induced a discomfort or an unpleasant feeling at the posterior part of the buttock, the thigh, the leg or in the foot reported by the participant.

    An electronical inclinometer will be used for the measurement of this angle, placed on the tibial bone using the anterior tibial tuberosity as a reference point.

    Measured: After 31 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2023
  2. Study start15 Jun 2023
  3. Primary completion4 Oct 2023
  4. Study completion4 Oct 2023

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05899244
Sponsor's protocol ID
ULiège Pesesse Pierre 02
Status last verified
Oct 2023
First submitted
5 Apr 2023
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing muscle streching exercice, Slider and Tensioner in people with Asymptomatic Condition, run by University of Liege at 1 site in Belgium.

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 2 inclusion and 11 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 5 Oct 2023. 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 Belgium. 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. 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?

Change of the limitation type during the Knee extension angle test (KEA) after 31 days (time frame: After 31 days). The study lists 4 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 5 Oct 2023.

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