The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly

Not Applicable

• Conditions: Balance, Postural; Elderly; Gait
• Interventions: Other: Manual therapy; Other: Placebo intervention

• Registration Number: NCT05475652
• Lead Sponsor: EZUS-LYON 1

Brief Summary

Falling is a major trauma that can occur with aging, leading to very significant psychological and physical health effects with financial and societal consequences. It is therefore essential to explore therapeutic treatments that can reduce this risk. Some recognized effective treatments exist, concerning in particular the re-education of the muscles of the lower limbs. However, to our knowledge, none of them focus on the cervical spine although the latter is located at an essential physiological crossroads. Manual therapy, which has already demonstrated its impact on pain and balance parameters in the elderly, could be a painless and non-invasive tool of choice in addressing this problem.

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 Timeline

• Study Start: 2020-02-04
• Study First Submitted: 2022-05-20
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-24
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-27
• Last Update Posted: 2022-07-28
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual therapy	Manual therapy	Manual therapy applied to the cervical spine.
Sham (ligth touch)	Placebo intervention	Placebo intervention composed of light touch treatment on the cervical spine.

Primary Outcome Measures

Name	Time	Method
change of walking speed at day 7 after a second intervention intervention	at Day 7 before and immediately after intervention in both groups	The subject will performed a 4m gait measurement
change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention	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)
change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention	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)
SPPB (Short Physical Performance Battery test) score at day 21	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)
change of walking speed at day 0 after 1 intervention	at Day 0 before and immediately after intervention in both groups	The subject will performed a 4m gait measurement
walking speed at day 21	at Day 21 in both groups, before the intervention for sham group	The subject will performed a 4m gait measurement

Secondary Outcome Measures

Name	Time	Method
change in Heart Rate Variability at day 0 after 1 intervention	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.
cervical muscle strength at day 21	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).
change in static posturography at day 0 after 1 intervention	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)
change in static posturography at day 7 after the second intervention	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)
static posturography at day 21	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)
change in plantar support at day 0 after 1 intervention	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
change in Heart Rate Variability at day 7 after the second intervention	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.
change in cervical range of motion at day 7 after the second intervention	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
cervical range of motion at day 21	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
quadriceps strength at day 21	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
change in cervical range of motion at day 0 after 1 intervention	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
change in cervical muscle strength at day 0 after 1 intervention	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).
change in cervical muscle strength at day 7 after the second intervention	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).
change in quadriceps strength at day 0 after 1 intervention	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
change in quadriceps strength at day 7 after the second intervention	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
plantar support at day 21	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
Heart Rate Variability at day 21	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.
change in plantar support at day 7 after the second intervention	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

Trial Locations

Locations (1)

Hôpital de la Croix-Rousse; 🇫🇷 Lyon, Rhône, France