NCT03286322

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

September 15, 2017

Last Update Submit

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

EXPERIMENTAL
Other: manuel therapy cervical spine

control group

SHAM COMPARATOR
Other: control group

Interventions

the manuel therapy in physiotherapy is focused on the cervival spine

manual therapy cervical spine

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

control group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sébastien GONFRIER, MD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

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

Locations