Disorders of BalanceNCT02899845
Study of Improving Gait Parameters When Using a Cane in "Light Touch" Condition in Elderly People With and Without Walking Difficulties
A study testing postural task and walk task in people with Disorders of Balance, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Disorders of Balance
- What is being tested?
- postural task and walk task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Nov 2017
- 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
- presence of gait disturbance or balance disorders defined by a geriatric assessment and / or a walking speed test
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Katja MAGALON, MD contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Katja MAGALON, MD, katja.magalon@ap-hm.fr
About this study
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
- Conditions
- Disorders of Balance
- Being tested
- postural task, walk task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postural taskOther
walk taskOther
| Study group | Role | What they receive |
|---|---|---|
| elderly people with walking difficulties | Experimental | subjects with proven gait disturbance and balance will be recruited from a walking speed test and a standardized geriatric assessment by a geriatrician Receives: Other: postural task; Other: walk task |
| elderly people without walking difficulties | Active comparator | 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 Receives: Other: postural task; Other: walk task |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of use of the cane
Measured: 12 mois
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2016 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders of BalanceStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899845
- Sponsor's protocol ID
- 2014-37
- Other IDs
- 2014-A01381-46
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Improving Gait Parameters When Using a Cane in "Light Touch" Condition in Elderly People With and Without Walking Difficulties
- ClinicalTrials.gov ID
- NCT02899845
- Acronym / sponsor ID
- 2014-37
- Conditions
- Disorders of Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 14 Sep 2016 (estimated)
- 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly people with walking difficulties | Experimental | Other: postural task, Other: walk tasksubjects with proven gait disturbance and balance will be recruited from a walking speed test and a standardized geriatric assessment by a geriatrician |
| elderly people without walking difficulties | Active comparator | Other: postural task, Other: walk tasksubjects 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 |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- presence of gait disturbance or balance disorders defined by a geriatric assessment and / or a walking speed test
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| postural task | Other | elderly people with walking difficulties, elderly people without walking difficulties |
| walk task | Other | elderly people with walking difficulties, elderly people without walking difficulties |
Primary outcome
number of use of the cane
Time frame: 12 mois
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Katja MAGALON, MD contact
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing postural task and walk task in people with Disorders of Balance, run by Assistance Publique Hopitaux De Marseille 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Sep 2016. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katja MAGALON, MD (katja.magalon@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of use of the cane (time frame: 12 mois). 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 14 Sep 2016.