- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882696
Evaluation of the Impact of Non-slip Socks on Motor Recovery in the Elderly (CHARM)
Evaluation of the Impact of Non-slip Socks on Motor Recovery in the Elderly An Open Label, Single-center, Randomized, Controlled Pilot Study
Some authors suggest a possible clinical interest of anti-slip socks. The scientific literature presents studies with methodological limitations. It is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population.
The investigatorswould therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Some authors suggest a possible clinical interest of anti-slip socks. The scientific literature presents studies with methodological limitations, but above all a different population than the one the investigators are interested in. It is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population.
Evaluating the value of these socks could allow to recommend them with solid data. Preventing this iatrogenic loss of autonomy would have a positive impact on the motor capacities of patients, a quicker and easier return home, and a reduction in health costs.
The investigators would therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
La Roche-sur-Yon, France, 85000
- Centre Hospitalier Departemental Vende
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient in Geriatric acute care or Post-Emergency Medicine,
- Patient 75 years and older,
- Patient requiring physiotherapy,
- Patient with a minimum of 7 days of physical therapy
- Patient arrived with unsuitable footwear (assessment at the discretion of the clinician: no back support, unsuitable size, etc.) or without footwear,
- Patient able to walk at least 10 m with or without technical assistance,
- Patient who has given oral consent
- Patient with social security coverage.
Exclusion Criteria:
- Inability to understand or perform study-specific clinical tests
- Known cognitive impairment, disease or condition that compromises comprehension of information or informed consent by the patient
- Blind patient
- Patient under guardianship or curatorship
- Patient participating in an interventional clinical research protocol that may alter the assessments of this protocol.
- Patient previously included in the Charm study
- Patient with an identified risk of being unable to wear socks or to walk barefoot within the next 7 days (need for compression stockings or socks, wound, excessive edema, orthostatic hypotension, other)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: usual care with bare feet
patients will be treated barefoot during their stay
|
|
|
Experimental: specific care with anti-slip socks
Patients in this group will wear non-slip socks
|
Patients will wear non-slip socks during their hospitalization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline walking speed (start of physiotherapy treatment) at D8.
Time Frame: Day 8
|
Change from Baseline walking speed at the patient's preferred speed over 10m between (start of physiotherapy treatment) at D8.
|
Day 8
|
Collaborators and Investigators
Investigators
- Principal Investigator: Thomas RULLEAU, Departmental Hospital Center of Vendee
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHD 20-0059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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