Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine
SATRACE
1 other identifier
interventional
86
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2016
CompletedFirst Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedMarch 18, 2024
March 1, 2024
2.8 years
September 15, 2017
March 15, 2024
Conditions
Outcome Measures
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.
at 3 weeks
Study Arms (2)
manual therapy cervical spine
EXPERIMENTALcontrol group
SHAM COMPARATORInterventions
the manuel therapy in physiotherapy is focused on the cervival spine
the manuel therapy in physiotherapy is classic and not focused on the cervival spine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice
Nice, 06000, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sébastien GONFRIER, MD
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 18, 2017
Study Start
December 16, 2016
Primary Completion
October 15, 2019
Study Completion
January 1, 2024
Last Updated
March 18, 2024
Record last verified: 2024-03