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

Elderly Clinical Trial

— ManEq  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05475652
• Other study ID #: 002B2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: EZUS-LYON 1
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Balance, Postural
• Elderly
• Gait

Intervention

Other:
• Manual therapy
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.
• Placebo intervention
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

Locations

Country	Name	City	State
France	Hôpital de la Croix-Rousse	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
EZUS-LYON 1

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention	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
Primary	change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention	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
Primary	SPPB (Short Physical Performance Battery test) score at day 21	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
Primary	change of walking speed at day 0 after 1 intervention	The subject will performed a 4m gait measurement	at Day 0 before and immediately after intervention in both groups
Primary	change of walking speed at day 7 after a second intervention intervention	The subject will performed a 4m gait measurement	at Day 7 before and immediately after intervention in both groups
Primary	walking speed at day 21	The subject will performed a 4m gait measurement	at Day 21 in both groups, before the intervention for sham group
Secondary	change in Heart Rate Variability at day 0 after 1 intervention	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
Secondary	change in Heart Rate Variability at day 7 after the second intervention	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
Secondary	Heart Rate Variability at day 21	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
Secondary	change in cervical range of motion at day 0 after 1 intervention	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
Secondary	change in cervical range of motion at day 7 after the second intervention	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
Secondary	cervical range of motion at day 21	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
Secondary	change in cervical muscle strength at day 0 after 1 intervention	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
Secondary	change in cervical muscle strength at day 7 after the second intervention	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
Secondary	cervical muscle strength at day 21	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
Secondary	change in quadriceps strength at day 0 after 1 intervention	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
Secondary	change in quadriceps strength at day 7 after the second intervention	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
Secondary	quadriceps strength at day 21	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
Secondary	change in static posturography at day 0 after 1 intervention	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
Secondary	change in static posturography at day 7 after the second intervention	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
Secondary	static posturography at day 21	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
Secondary	change in plantar support at day 0 after 1 intervention	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
Secondary	change in plantar support at day 7 after the second intervention	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
Secondary	plantar support at day 21	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