NCT05899244

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

April 5, 2023

Last Update Submit

October 4, 2023

Conditions

Keywords

Straight leg raising testKnee extension angleNeural mobilizationMuscle StretchingAsympotmatic subject

Outcome Measures

Primary Outcomes (4)

  • 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.

    After 31 days

  • 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.

    After 31 days

  • 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.

    After 31 days

  • 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.

    After 31 days

Study Arms (8)

Muscle limitation subgroup receiving muscle stretching exercice

EXPERIMENTAL

This 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.

Other: muscle streching exercice

Muscle limitation subgroup receiving a slider exercice

EXPERIMENTAL

This 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.

Other: Slider

Muscle limitation subgroup receiving a tensioner exercice

EXPERIMENTAL

This 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.

Other: Tensioner

Neural limitation subgroup receiving a muscle stretching exercice

EXPERIMENTAL

This 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.

Other: muscle streching exercice

Neural limitation subgroup receiving a slider exercice

EXPERIMENTAL

This 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.

Other: Slider

Neural limitation subgroup receiving a tensioner exercice

EXPERIMENTAL

This 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.

Other: Tensioner

Neural limitation Control subgroup

NO INTERVENTION

Participants in this subgroup will not receive an intervention.

Muscle limitation Control subgroup

NO INTERVENTION

Participants in this subgroup will not receive an intervention.

Interventions

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.

Muscle limitation subgroup receiving muscle stretching exerciceNeural limitation subgroup receiving a muscle stretching exercice
SliderOTHER

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.

Also known as: neural sliding mobilization
Muscle limitation subgroup receiving a slider exerciceNeural limitation subgroup receiving a slider exercice

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.

Also known as: neural tensioning mobilization
Muscle limitation subgroup receiving a tensioner exerciceNeural limitation subgroup receiving a tensioner exercice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults
  • Asymptomatic subject

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNiversity of liege

Liège, Liege, 4000, Belgium

Location

MeSH Terms

Conditions

Asymptomatic Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre Pesesse, master

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor is blind to participant group allocation. After the first evaluation participant are conduct in another room where a second investigator allocate them to a subgroup and give them instructions concerning the intervention. After a month the re-avaluation takes place and patient are told to keep secret their affiliation group until the end of the re-evaluation in order to keep the outcomes assessor blind.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiopherapist PHD student

Study Record Dates

First Submitted

April 5, 2023

First Posted

June 12, 2023

Study Start

June 15, 2023

Primary Completion

October 4, 2023

Study Completion

October 4, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations