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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Unknown status
CT.gov ID
NCT03286322
Collaborator
(none)
86
1
2
27.5
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: manuel therapy cervical spine
  • Other: control group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine to Improve Balance in Elderly Patients
Actual Study Start Date :
Dec 16, 2016
Anticipated Primary Completion Date :
Oct 15, 2018
Anticipated Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: manual therapy cervical spine

Other: manuel therapy cervical spine
the manuel therapy in physiotherapy is focused on the cervival spine

Sham Comparator: control group

Other: control group
the manuel therapy in physiotherapy is classic and not focused on the cervival spine

Outcome Measures

Primary Outcome Measures

  1. Percentage decrease of the wobbling surface eyes open on steady ground, on a posturology platform [at 3 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
75 Years and Older
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Nice Nice France 06000

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: SĂ©bastien GONFRIER, MD, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT03286322
Other Study ID Numbers:
  • 2016-A00521-50
First Posted:
Sep 18, 2017
Last Update Posted:
Sep 18, 2017
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 18, 2017