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
- 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 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.
- More trials run by University Hospital, LilleThe 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of the CALIGALOC Orthosis on Standing and Walking of Hemiparetic Patients With Ankle Varus
- ClinicalTrials.gov ID
- NCT03668561
- Acronym / sponsor ID
- CALIGALOC / 2017_01
- Conditions
- Hemiparesis, Varus Deformity of Equine Carpus
- Keywords
- stroke, hemiplegia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 22 Feb 2019 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 12 Sep 2018 (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.
To assess the benefit of an anti-varus ankle foot orthosis (CALIGALOC, Bauerfeind) on gait and balance parameters in hemiparetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (CALIGALOC) | Experimental | Device: CaligalocWearing of the Caligaloc orthosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Caligaloc15 days of wearing of the Caligaloc orthosis | Device | Treatment (CALIGALOC) |
Primary outcome
10-meter walk test (in seconds)
Time frame: comparison between baseline and 15 days
Maximum gait velocity, from a standing start
6 secondary outcomes
Assessment of gait temporospatial parameters by GaitRite®
Time frame: comparison between baseline and 15 days
Posturographic analysis during static upright stance (center of pressure surface)
Time frame: comparison between baseline and 15 days
Baropodometric analysis during gait
Time frame: comparison between baseline and 15 days
Gait endurance (2-minute walk test)
Time frame: comparison between baseline and 15 days
Assessment of walking function
Time frame: comparison between baseline and 15 days
Tolerability of the wearing of the Caligaloc orthosis assessed by visual analog scale
Time frame: at 15 days
Results and safety
The study was stopped early (reason given: COVID). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Related trials for Hemiparesis
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
Hemiparesis, Ischemic Stroke
Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
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.
Etienne Allart, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caligaloc in people with Hemiparesis and Varus Deformity of Equine Carpus, run by University Hospital, Lille 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 3 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: stopped early, as of the sponsor's last update on 22 May 2026. 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?
The study was stopped early (reason given: COVID). Results are not available in the source record.
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?
10-meter walk test (in seconds) (time frame: comparison between baseline and 15 days). 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 22 May 2026.