HemiparesisCALIGALOCNCT03668561
the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
A study testing Caligaloc in people with Hemiparesis and Varus Deformity of Equine Carpus, run by University Hospital, Lille at 1 site in France.
Trial summary
To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiparesis, Varus Deformity of Equine Carpus
- What is being tested?
- Caligaloc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2019to 18 Nov 2021
- Phase
- Interventional
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiparesis at > 3 months (whatever the etiology)
- varus or equinovarus foot disturbing the stance phase of gait
- Able to walk at least 10m, with or without assistive device
Who cannot join
- unable to walk 10m
- Botulinum toxin injection less than 3 months before inclusion
- history of neurological or locomotor pathology in addition to the etiology of hemiparesis
- Severe comprehension troubles
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.
- Conditions
- Hemiparesis, Varus Deformity of Equine Carpus
- Being tested
- Caligaloc
- Keywords
- stroke, hemiplegia
- Medical subject headings
- Paresis, Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaligalocDevice
15 days of wearing of the Caligaloc orthosis
| Study group | Role | What they receive |
|---|---|---|
| Treatment (CALIGALOC) | Experimental | Wearing of the Caligaloc orthosis Receives: Device: Caligaloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walk test (in seconds)
Maximum gait velocity, from a standing start
Measured: comparison between baseline and 15 days
Secondary outcomes (6)
Assessment of gait temporospatial parameters by GaitRite®
Specific temporal and spatial parameters of gait will be measured with the GaitRite gait evaluation system: gait cadence, hemiparetic step length, spatial asymmetry, swing and stance times.
Measured: comparison between baseline and 15 days
Posturographic analysis during static upright stance (center of pressure surface)
Assessment of displacements of the center of pressure during quiet upright standing for 30s, using a Zebris platform
Measured: comparison between baseline and 15 days
Baropodometric analysis during gait
Assessment of the paretic footprint during gait, using the Zebris platform
Measured: comparison between baseline and 15 days
Gait endurance (2-minute walk test)
Assessment of maximum gait perimeter during a 2mwt
Measured: comparison between baseline and 15 days
Assessment of walking function
Lower Limb Function assessment scale (LL-FAS, Allart et al. 2015) functional subscores
Measured: comparison between baseline and 15 days
Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale
visual analog scale (0=major discomfort - 10=excellent comfort)
Measured: at 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start22 Feb 2019
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne Allart, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668561
- Sponsor's protocol ID
- 2017_01
- Other IDs
- 2017-A02098-45
- Acronym
- CALIGALOC
- Status last verified
- May 2026
- First submitted
- 1 Aug 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No