- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02899845
Study of Improving Gait Parameters When Using a Cane in "Light Touch" Condition in Elderly People With and Without Walking Difficulties
September 9, 2016 updated by: Assistance Publique Hopitaux De Marseille
This project aims to study the effect of haptic sensory information delivered at the hand using a cane in "light touch" or "light support" condition on postural stability and spatial and temporal gait parameters of elderly subjects with and without walking difficulties
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katja MAGALON, MD
- Email: katja.magalon@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13005
- Recruiting
- Assistance Publique Hopitaux de Marseille
-
Contact:
- Katja MAGALON, MD
- Email: katja.magalon@ap-hm.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- presence of gait disturbance or balance disorders defined by a geriatric assessment and / or a walking speed test
Exclusion Criteria:
- presence of acute problems or central or peripheral neurological severe sequelae
- occurrence of a recent fracture of the lower limbs or spinal fracture
- cognitive disorders
- presence of comorbidities: blindness, heart or severe respiratory failure, disabling osteoarthritis of the hands or legs, severe malnutrition, muscle atrophy, untreated orthostatic hypotension
- patients using a cane to a mechanical support
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: elderly people with walking difficulties
subjects with proven gait disturbance and balance will be recruited from a walking speed test and a standardized geriatric assessment by a geriatrician
|
|
Active Comparator: elderly people without walking difficulties
subjects with no gait disturbance and balance disorders will be recruited from a walking speed test and a standardized geriatric assessment, once the subjects with gait disturbance and balance disorders have been recruited in order to make a match on the age criterion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of use of the cane
Time Frame: 12 mois
|
12 mois
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Anticipated)
November 1, 2016
Study Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
September 9, 2016
First Submitted That Met QC Criteria
September 9, 2016
First Posted (Estimate)
September 14, 2016
Study Record Updates
Last Update Posted (Estimate)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 9, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 2014-37
- 2014-A01381-46 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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