Clinical trial NCT05475652: The Influence of Manual Therapy Applied to the Cervical Spine in the Prevention of Balance Disorders in the Elderly
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Balance, Postural
Gait
Elderly
Keywords: senior;
gait
neck
myofascial release
Lead sponsor: EZUS-LYON 1
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change of SPPB (Short Physical Performance Battery test) score at day 0 after 1 intervention
timeFrame: at Day 0 before and immediately after intervention in both groups
measure: change of SPPB (Short Physical Performance Battery test) score at day 7 after a second intervention
timeFrame: at Day 7 before and immediately after intervention in both groups
measure: SPPB (Short Physical Performance Battery test) score at day 21
timeFrame: at Day 21 in both groups before the intervention for sham group
measure: change of walking speed at day 0 after 1 intervention
timeFrame: at Day 0 before and immediately after intervention in both groups
measure: change of walking speed at day 7 after a second intervention intervention
timeFrame: at Day 7 before and immediately after intervention in both groups
measure: walking speed at day 21
timeFrame: at Day 21 in both groups, before the intervention for sham group
Secondary outcomes:
measure: change in Heart Rate Variability at day 0 after 1 intervention
timeFrame: at Day 0 before and immediately after intervention in both groups
measure: change in Heart Rate Variability at day 7 after the second intervention
timeFrame: at Day 7 before and immediately after intervention in both groups
measure: Heart Rate Variability at day 21
timeFrame: at Day 21 before the intervention for sham group
measure: change in cervical range of motion at day 0 after 1 intervention
timeFrame: at Day 0 before and immediately after intervention in both groups
measure: change in cervical range of motion at day 7 after the second intervention
timeFrame: at Day 7 before and immediately after intervention in both groups
measure: cervical range of motion at day 21
timeFrame: at Day 21 before the intervention for sham group
measure: change in cervical muscle strength at day 0 after 1 intervention
timeFrame: at Day 0 before and immediately after intervention in both groups
measure: change in cervical muscle strength at day 7 after the second intervention
timeFrame: at Day 7 before and immediately after intervention in both groups
measure: cervical muscle strength at day 21
timeFrame: at Day 21 before the intervention for sham group
measure: change in quadriceps strength at day 0 after 1 intervention
timeFrame: At Day 0 before and immediately after intervention in both groups
measure: change in quadriceps strength at day 7 after the second intervention
timeFrame: At Day 7 before and immediately after intervention in both groups
measure: quadriceps strength at day 21
timeFrame: At Day 21 before the intervention for sham group
measure: change in static posturography at day 0 after 1 intervention
timeFrame: At Day 0 before and immediately after intervention in both groups
measure: change in static posturography at day 7 after the second intervention
timeFrame: At Day 7 before and immediately after intervention in both groups
measure: static posturography at day 21
timeFrame: At Day 21 before the intervention for sham group
measure: change in plantar support at day 0 after 1 intervention
timeFrame: At Day 0 before and immediately after intervention in both groups
measure: change in plantar support at day 7 after the second intervention
timeFrame: At Day 7 before and immediately after intervention in both groups
measure: plantar support at day 21
timeFrame: At Day 21 before the intervention for sham group
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
state: Rhône
Study officials:
affiliation: Laboratoire Interuniversitaire de Biologie de la Motricité
name: Laurianne PINLOCHE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinloche L, Souvignet S, Germain M, Monteil K, Hautier C. The short-term effect of a myofascial protocol versus light touch applied to the cervical spine towards the prevention of balance disorders in the elderly: protocol of a randomised controlled trial. Chiropr Man Therap. 2022 Aug 31;30(1):33. doi: 10.1186/s12998-022-00446-0.