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CompletedNCT03286322SATRACEUpdated Mar 18, 2024

Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine

An interventional study of manuel therapy cervical spine and control group in Loss of Balance, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
75 Years and older
Sex
All
01

Study summary

In more than 90% of cases, victims of fall are elderly people over 65. Nearly the third of those people fall at least 1 time by year. The incidence substantially increases for people over 80 and women are at higher risk than men.

The value of balance rehabilitation no longer needs to be demonstrated in Gerontology. Nevertheless, a more specific therapy based on the aged-related cervical problems seems to be essential. Indeed, those problems are numerous (arthrosis-like pains, joint stiffness, muscular contractures...) and often lessen vestibular and/or proprioceptive afferents. The cervical spine is a link between different systems which regulate balance, as the visual, vestibular and cervical systems (muscular, articular afferents...), and this role is key to balance control. Indeed, the cervical spine owns an exceptional function thanks to Ruffinian corpuscles, muscle and neurotendinal spindles.

Many studies point up the importance of the relation between balance, cervical spine and vestibular system, and others between tissue changes and postural adaptations in elderly people. Nevertheless, the take into consideration of all these data and their impacts in rehabilitation has not been reported yet.

This brings us to question the added-value of a cervical mobility management in balance rehabilitation in Gerontology.

02

Conditions studied

  • Loss of Balance
03

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients over 75 hospitalized in rehabilitation department and long-term unit of Cimiez Hospital
  • With MMSE > 20
  • In need of balance rehabilitation
  • Who can stand Bipodal position for >1 minute
  • Who can walk for more than 10 meters without walking aid
  • Having signed an informed consent
  • Affiliated to a health insurance plan

Exclusion criteria

Exclusion Criteria:

  • Motor neurological deficit, specific vestibular pathologies
  • Patient hospitalized for traumatological pathology or who has been hospitalized for traumatological pathology within 3 months
  • Vulnerable people: adults under guardianship, deprived of freedom
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    manual therapy cervical spine

    Other: manuel therapy cervical spine

  • Sham comparator
    control group

    Other: control group

Interventions

  • Othermanuel therapy cervical spine

    the manuel therapy in physiotherapy is focused on the cervival spine

  • Othercontrol group

    the manuel therapy in physiotherapy is classic and not focused on the cervival spine

05

What researchers measure

Primary outcomes

  1. Percentage decrease of the wobbling surface eyes open on steady ground, on a posturology platform

    To compare the balance improvement, thanks to a posturology platform, between 2 groups of elderly patients hospitalized for balance disorders, in order to highlight the way of manual therapy in physiotherapy, focused on the cervical spine, can increase these parameters and contribute to lessen the risk of falls in elderly people.

    Time frame: at 3 weeks

06

Study locations

1 site
  • CHU de Nice
    Nice, 06000, France
07

Registry details

Key details

Study ID
NCT03286322
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Dec 16, 2016
Primary completion
Oct 15, 2019
Completion
Jan 1, 2024
Last update
Mar 18, 2024

Study contacts

Sébastien GONFRIER, MD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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