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

Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine to Improve Balance in Elderly Patients

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.

Study Overview

• Status: Completed
• Conditions: Loss of Balance
• Intervention / Treatment: Other: manuel therapy cervical spine; Other: control group

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06000
    • CHU de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group	Other: control group; the manuel therapy in physiotherapy is classic and not focused on the cervival spine
Experimental: manual therapy cervical spine	Other: manuel therapy cervical spine; the manuel therapy in physiotherapy is focused on the cervival spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Sébastien GONFRIER, MD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2016
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2016-A00521-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No