- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475652
The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly (ManEq)
The Influence of Manual Therapy Applied to the Cervical Spine (Versus Light Touch) in the Prevention of Balance Disorders in the Elderly: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main hypothesis of the present study is therefore that manual therapy applied to the cervical spine may have a beneficial impact on the balance and motor performance of seniors. The study also aims to propose an assessment of the physical parameters of balance, in order to validate the contribution of the cervical spine in compensatory mechanisms.
To do so, an interventional study was designed, monocentric, prospective, controlled, randomized double-blind (patient and evaluator performing the measurements). The experiment will take place over three measurement periods on D0, D7 and D21.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhône
-
Lyon, Rhône, France, 69004
- Hopital de la Croix-Rousse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65 years of age or older, of either sex
- Autonomous, able to walk ten meters alone without walking aid
- Able to understand instructions necessary for the correct performance of the measurements.
Exclusion Criteria:
- Patients suffering from a locomotor handicap or severe chronic progressive pathologies preventing the protocol from being carried out correctly
- Patient who has an history of surgery - fracture - dislocation of the cervical spine
- Patient who has cognitive impairments (Mini Mental Statement <20)
- Patient who has life expectancy less than 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Sham (ligth touch)
Placebo intervention composed of light touch treatment on the cervical spine.
|
The Sham group receives placebo treatment twice (D0 and D7).
This placebo treatment also called "light touch" treatment consists of applying light pressure with broad support from both hands on either side of the joint, in contact with the skin, without equal bone pressure or therapeutic intention, for a duration comparable to that of manual therapy.
Outcomes are evaluation before and after placebo intervention.
The same schedule will be reproduced at D7. On D21, only one assessment will be done at the beginning of the session and a manual therapy treatment on the cervical spine is provided to balance access to care in the two group
|
Experimental: Manual therapy
Manual therapy applied to the cervical spine.
|
The manual therapy intervention is performed twice on the experimental group, once on day 0 (D0) and the second time on day 7 (D7).
This intervention consists of a manual therapy protocol (base on myofascial release) applied to the cervical spine.
Protocol consists of succession of techniques: suboccipital decompression, disengagement of Cervical 0-1-2,vibratory stimulation at C4 level and myofascial release technique of the cervical aponeuroses.
Outcomes are evaluated before and after intervention.The same schedule will be reproduced on D7.
On D21, only one assessment will be done at the beginning of the session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention
Time Frame: at Day 0 before and immediately after intervention in both groups
|
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
|
at Day 0 before and immediately after intervention in both groups
|
change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention
Time Frame: at Day 7 before and immediately after intervention in both groups
|
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
|
at Day 7 before and immediately after intervention in both groups
|
SPPB (Short Physical Performance Battery test) score at day 21
Time Frame: at Day 21 in both groups before the intervention for sham group
|
The subject will then be asked to stand up and perform the different steps of the Short Physical Performance Battery test following the instructions of the evaluator, leading to a score between 0 (worse score) and 12 (best score)
|
at Day 21 in both groups before the intervention for sham group
|
change of walking speed at day 0 after 1 intervention
Time Frame: at Day 0 before and immediately after intervention in both groups
|
The subject will performed a 4m gait measurement
|
at Day 0 before and immediately after intervention in both groups
|
change of walking speed at day 7 after a second intervention intervention
Time Frame: at Day 7 before and immediately after intervention in both groups
|
The subject will performed a 4m gait measurement
|
at Day 7 before and immediately after intervention in both groups
|
walking speed at day 21
Time Frame: at Day 21 in both groups, before the intervention for sham group
|
The subject will performed a 4m gait measurement
|
at Day 21 in both groups, before the intervention for sham group
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Heart Rate Variability at day 0 after 1 intervention
Time Frame: at Day 0 before and immediately after intervention in both groups
|
Participants will be equipped with a heart rate monitor (Polar RS800) and a heart belt to collect HRV.
The watch will be placed on the subjects' wrists and the belt on the chest (under the pectoral muscles for men and under the bra for women).
The skin under the sensor will be slightly moistened to ensure good electrical contact and to avoid artifacts.
The belt must be tight enough to ensure that the sensor is in perfect contact with the skin but must remain comfortable.
Thus, a total recording time of 5 minutes, in the supine position and with spontaneous breathing, will be performed on each patient.
|
at Day 0 before and immediately after intervention in both groups
|
change in Heart Rate Variability at day 7 after the second intervention
Time Frame: at Day 7 before and immediately after intervention in both groups
|
Participants will be equipped with a heart rate monitor (Polar RS800) and a heart belt to collect HRV.
The watch will be placed on the subjects' wrists and the belt on the chest (under the pectoral muscles for men and under the bra for women).
The skin under the sensor will be slightly moistened to ensure good electrical contact and to avoid artifacts.
The belt must be tight enough to ensure that the sensor is in perfect contact with the skin but must remain comfortable.
Thus, a total recording time of 5 minutes, in the supine position and with spontaneous breathing, will be performed on each patient.
|
at Day 7 before and immediately after intervention in both groups
|
Heart Rate Variability at day 21
Time Frame: at Day 21 before the intervention for sham group
|
Participants will be equipped with a heart rate monitor (Polar RS800) and a heart belt to collect HRV.
The watch will be placed on the subjects' wrists and the belt on the chest (under the pectoral muscles for men and under the bra for women).
The skin under the sensor will be slightly moistened to ensure good electrical contact and to avoid artifacts.
The belt must be tight enough to ensure that the sensor is in perfect contact with the skin but must remain comfortable.
Thus, a total recording time of 5 minutes, in the supine position and with spontaneous breathing, will be performed on each patient.
|
at Day 21 before the intervention for sham group
|
change in cervical range of motion at day 0 after 1 intervention
Time Frame: at Day 0 before and immediately after intervention in both groups
|
the patients will be seated in a neutral position, with their backs against the back of the chair, and will perform the cervical range of motion tests.
For this, the experimenter will use the anatomical points previously identified: ear tragus, chin symphysis, anterior angle of the acromion, sternal incisure.
The subject will be asked to perform movements of flexion, extension, right rotation, left rotation, right tilt, and left tilt, returning to the neutral position each time.
All movements will be performed 3 times.
The measurement will retain the difference between the neutral position and the maximum position of the movement
|
at Day 0 before and immediately after intervention in both groups
|
change in cervical range of motion at day 7 after the second intervention
Time Frame: at Day 7 before and immediately after intervention in both groups
|
the patients will be seated in a neutral position, with their backs against the back of the chair, and will perform the cervical range of motion tests.
For this, the experimenter will use the anatomical points previously identified: ear tragus, chin symphysis, anterior angle of the acromion, sternal incisure.
The subject will be asked to perform movements of flexion, extension, right rotation, left rotation, right tilt, and left tilt, returning to the neutral position each time.
All movements will be performed 3 times.
The measurement will retain the difference between the neutral position and the maximum position of the movement
|
at Day 7 before and immediately after intervention in both groups
|
cervical range of motion at day 21
Time Frame: at Day 21 before the intervention for sham group
|
the patients will be seated in a neutral position, with their backs against the back of the chair, and will perform the cervical range of motion tests.
For this, the experimenter will use the anatomical points previously identified: ear tragus, chin symphysis, anterior angle of the acromion, sternal incisure.
The subject will be asked to perform movements of flexion, extension, right rotation, left rotation, right tilt, and left tilt, returning to the neutral position each time.
All movements will be performed 3 times.
The measurement will retain the difference between the neutral position and the maximum position of the movement
|
at Day 21 before the intervention for sham group
|
change in cervical muscle strength at day 0 after 1 intervention
Time Frame: at Day 0 before and immediately after intervention in both groups
|
the cervical strength tests will be performed seated too, using a manual dynamometer (Micro FET2, Hoggan, Salt Lake City, USA).
To obtain the maximum isometric force of the neck muscles in the 6 movements, a "make test" will be performed: the experimenter will resist the subject's force without trying to exceed it.
The subject will be asked to perform progressively and as hard as possible, from the neutral position, a flexion movement (resistance applied under the chin), an extension movement (resistance applied to the back of the occiput), a right and left rotation movement (resistance applied along the horizontal side of the right and left mandibles), and a right and left tilt movement (resistance applied above the right and left ears).
|
at Day 0 before and immediately after intervention in both groups
|
change in cervical muscle strength at day 7 after the second intervention
Time Frame: at Day 7 before and immediately after intervention in both groups
|
the cervical strength tests will be performed seated too, using a manual dynamometer (Micro FET2, Hoggan, Salt Lake City, USA).
To obtain the maximum isometric force of the neck muscles in the 6 movements, a "make test" will be performed: the experimenter will resist the subject's force without trying to exceed it.
The subject will be asked to perform progressively and as hard as possible, from the neutral position, a flexion movement (resistance applied under the chin), an extension movement (resistance applied to the back of the occiput), a right and left rotation movement (resistance applied along the horizontal side of the right and left mandibles), and a right and left tilt movement (resistance applied above the right and left ears).
|
at Day 7 before and immediately after intervention in both groups
|
cervical muscle strength at day 21
Time Frame: at Day 21 before the intervention for sham group
|
the cervical strength tests will be performed seated too, using a manual dynamometer (Micro FET2, Hoggan, Salt Lake City, USA).
To obtain the maximum isometric force of the neck muscles in the 6 movements, a "make test" will be performed: the experimenter will resist the subject's force without trying to exceed it.
The subject will be asked to perform progressively and as hard as possible, from the neutral position, a flexion movement (resistance applied under the chin), an extension movement (resistance applied to the back of the occiput), a right and left rotation movement (resistance applied along the horizontal side of the right and left mandibles), and a right and left tilt movement (resistance applied above the right and left ears).
|
at Day 21 before the intervention for sham group
|
change in quadriceps strength at day 0 after 1 intervention
Time Frame: At Day 0 before and immediately after intervention in both groups
|
to measure the maximal isometric extension force of the dominant quadriceps by applying the dynamometer to the lower tibia and requesting leg extension from a 90° flexion position
|
At Day 0 before and immediately after intervention in both groups
|
change in quadriceps strength at day 7 after the second intervention
Time Frame: At Day 7 before and immediately after intervention in both groups
|
to measure the maximal isometric extension force of the dominant quadriceps by applying the dynamometer to the lower tibia and requesting leg extension from a 90° flexion position
|
At Day 7 before and immediately after intervention in both groups
|
quadriceps strength at day 21
Time Frame: At Day 21 before the intervention for sham group
|
to measure the maximal isometric extension force of the dominant quadriceps by applying the dynamometer to the lower tibia and requesting leg extension from a 90° flexion position
|
At Day 21 before the intervention for sham group
|
change in static posturography at day 0 after 1 intervention
Time Frame: At Day 0 before and immediately after intervention in both groups
|
the static posturography test will be performed under standard conditions using the WIN-POSTURO platform (Medicapteur, Balma, France) allowing the measurement of displacements of the center of pressure in a static standing position at a frequency of 40 Hz for 25.6 seconds . The measurement will be repeated 3 times. The data collected will be processed using WIN-POSTURO software (Medicapteur, Balma, France) |
At Day 0 before and immediately after intervention in both groups
|
change in static posturography at day 7 after the second intervention
Time Frame: At Day 7 before and immediately after intervention in both groups
|
the static posturography test will be performed under standard conditions using the WIN-POSTURO platform (Medicapteur, Balma, France) allowing the measurement of displacements of the center of pressure in a static standing position at a frequency of 40 Hz for 25.6 seconds . The measurement will be repeated 3 times. The data collected will be processed using WIN-POSTURO software (Medicapteur, Balma, France) |
At Day 7 before and immediately after intervention in both groups
|
static posturography at day 21
Time Frame: At Day 21 before the intervention for sham group
|
the static posturography test will be performed under standard conditions using the WIN-POSTURO platform (Medicapteur, Balma, France) allowing the measurement of displacements of the center of pressure in a static standing position at a frequency of 40 Hz for 25.6 seconds . The measurement will be repeated 3 times. The data collected will be processed using WIN-POSTURO software (Medicapteur, Balma, France) |
At Day 21 before the intervention for sham group
|
change in plantar support at day 0 after 1 intervention
Time Frame: At Day 0 before and immediately after intervention in both groups
|
The subject will perform the 4 m gait measurement part (which will measure walking speed) equipped with W-INSHOE plantar sensors (Medicapteur, Balam, France) which will be analyzed using the software of the same name.
The sensors are attached to the skin with hypoallergenic tape
|
At Day 0 before and immediately after intervention in both groups
|
change in plantar support at day 7 after the second intervention
Time Frame: At Day 7 before and immediately after intervention in both groups
|
The subject will perform the 4 m gait measurement part (which will measure walking speed) equipped with W-INSHOE plantar sensors (Medicapteur, Balam, France) which will be analyzed using the software of the same name.
The sensors are attached to the skin with hypoallergenic tape
|
At Day 7 before and immediately after intervention in both groups
|
plantar support at day 21
Time Frame: At Day 21 before the intervention for sham group
|
The subject will perform the 4 m gait measurement part (which will measure walking speed) equipped with W-INSHOE plantar sensors (Medicapteur, Balam, France) which will be analyzed using the software of the same name.
The sensors are attached to the skin with hypoallergenic tape
|
At Day 21 before the intervention for sham group
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurianne PINLOCHE, MD, Laboratoire Interuniversitaire de Biologie de la Motricité
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 002B2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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