Loss of BalanceSATRACENCT03286322
Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine
A study testing manuel therapy cervical spine in people with Loss of Balance, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Loss of Balance
- What is being tested?
- manuel therapy cervical spine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 16 Dec 2016to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Loss of Balance
- Being tested
- manuel therapy cervical spine, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manuel therapy cervical spineOther
the manuel therapy in physiotherapy is focused on the cervival spine
control groupOther
the manuel therapy in physiotherapy is classic and not focused on the cervival spine
| Study group | Role | What they receive |
|---|---|---|
| manual therapy cervical spine | Experimental | Not described Receives: Other: manuel therapy cervical spine |
| control group | Sham comparator | Not described Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start16 Dec 2016
- Primary completion15 Oct 2019
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of BalanceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien GONFRIER, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286322
- Sponsor's protocol ID
- 2016-A00521-50
- Acronym
- SATRACE
- Status last verified
- Mar 2024
- First submitted
- 15 Sep 2017
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Classical Rehabilitation Method and a Specific Rehabilitation Method of the Cervical Spine to Improve Balance in Elderly Patients
- ClinicalTrials.gov ID
- NCT03286322
- Acronym / sponsor ID
- SATRACE / 2016-A00521-50
- Conditions
- Loss of Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual therapy cervical spine | Experimental | Other: manuel therapy cervical spine |
| control group | Sham comparator | Other: control group |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| manuel therapy cervical spinethe manuel therapy in physiotherapy is focused on the cervival spine | Other | manual therapy cervical spine |
| control groupthe manuel therapy in physiotherapy is classic and not focused on the cervival spine | Other | control group |
Primary outcome
Percentage decrease of the wobbling surface eyes open on steady ground, on a posturology platform
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien GONFRIER, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manuel therapy cervical spine in people with Loss of Balance, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage decrease of the wobbling surface eyes open on steady ground, on a posturology platform (time frame: at 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.