Hemiparesis;Poststroke/CVAMECASPRYNCT04323943
Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
A study testing Ankle Foot orthosis (AFO) in people with Hemiparesis;Poststroke/CVA and Gait, Hemiplegic, run by Thuasne at 1 site in France.
Trial summary
Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. This impairment, termed as "foot drop", is caused by an association of weak dorsiflexors and increased spasticity and stiffness of the plantar-flexors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiparesis;Poststroke/CVA, Gait, Hemiplegic
- What is being tested?
- Ankle Foot orthosis (AFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 7 Sep 2020to 23 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
- Hemiparetic patients, walking with CM-AFO
- Diagnosis of a first stroke since at least 6 months with medical conditions of stroke known, treatment proposed, cardio-vascular and neurological state stabilized
- Foot drop observed during the swing phase of gait, requiring the use of a custom-made plastic orthosis that has been used for at least 3 months and used for less than 2 years
- Muscle spasticity not higher than grade 3 according to the Modified Ashworth Scale
- Sufficient motor ability and endurance to ambulate at least 15 m independently without AFO
- Patient who signed a consent
- Patients affiliated or entitled to a social security system.
Who cannot join
- Patients who did not have brain MRI imaging after their stroke to confirm the diagnosis of stroke,
- Patients with an associated cerebellar syndrome,
- Patients with clinical brainstem involvement (cranial pair deficit),
- Patients with a neurological history other than stroke that has an impact on walking,
- Patients with unstable cardiovascular or respiratory disorders likely to induce gait disorders that may influence the performance of the tests to a greater extent than in the case of vascular hemiplegics,
- Patients with alcohol or drug dependence,
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- Patients with psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant pathology, renal impairment, unstable or decompensated diabetes, severe,
- Patients with a history of associated disabling systemic disease,
- Patients who refused to sign the written consent,
- Patients with a current pregnancy,
- Patients under court protection.
Trial locations and contacts
1 site in 1 country.
About this study
Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. This impairment, termed as "foot drop", is caused by an association of weak dorsiflexors and increased spasticity and stiffness of the plantar-flexors. As a consequence, walking performances are reduced and energy cost of walking is deteriorated. This may increase performance fatigability, as the locomotion will be realized at a higher percentage of the subjects' capacities. In order to overcome these issues, different treatments are proposed. One of the most conventional solutions are the use of ankle foot orthosis (AFO) and it is the most commonly prescribed device used to compensate for "foot drop". There is a very large choice of AFO on the market which can be proposed to patients with foot drop.
The aim of this study is thus to assess the mechanical effects of using a manufactured carbon AFO in by comparison to a custom-made thermo-plastic AFO on walking capacity (distance and energy cost), fatigue and "foot drop" control throughout the gait phase in patients with hemiparetic stroke.
- Conditions
- Hemiparesis;Poststroke/CVA, Gait, Hemiplegic
- Being tested
- Ankle Foot orthosis (AFO)
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Foot orthosis (AFO)Device
Also called Sprystep (Thuasne)
The experimental protocol will require 4 visits: one inclusion visit and 3 visits for evaluations. Each visit corresponds to one condition: C-AFO, CM-AFO or NO (according to a random order).
Visit #1 will consist in a clinical evaluation and a familiarization session with the measuring devices and methodologies used in visit#2 #3 and #4.
During #2, #3 and #4 visits (14 days between each session), the subject will perform with C-AFO, CM-AFO or NO according to the random order :
- 5 x 15m overground at a comfortable walking speed (CWS) where EMG, ground reaction force and kinematics will be measured
- 6MWT where energy cost will be measured
- 5 x 15m overground (immediately after the 6MWT) at a comfortable walking speed
| Study group | Role | What they receive |
|---|---|---|
| Carbon-AFO (C-AFO) | Experimental | Manufactured carbon ankle foot orthosis (C-AFO) Sprystep (Thuasne) will be provided to patients. A familiarization with C-AFO will be performed before doing the tests. Receives: Device: Ankle Foot orthosis (AFO) |
| Custom-made thermo-plastic orthosis (CM-AFO) | Active comparator | Own custom-made thermo-plastic orthosis (CM-AFO) of patients. A familiarization will be performed also before doing the tests. Receives: Device: Ankle Foot orthosis (AFO) |
| Without orthosis (NO) | No intervention | No orthosis - patient will wear only their shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked during the 6 Minute Walk Test (6MWT)
Patient will performed three experimental session (14 days between each session) during wich the primary outcome will be assessed : one session while walking with C-AFO, one session while walking with CM-AFO, and one session while walking without AFO (randomized order).
6 Minute Walk Test is a beneficial tool to evaluate walking endurance in patients with poststroke hemiparesis
Measured: Day : 14
Secondary outcomes (7)
Energy cost
Energy cost will be assessed by oxygen consumption recorded during the 6MWT in the 3 conditions (C-AFO, CM-AFO, NO)
Measured: Day : 14
Muscular activity
Muscular activity will be assessed by electromyography (EMG) on different muscles (anterior tibial, gastroc medial, femoral). Muscular activity will be assessed before and after 6MWT during 5*15m sessions
Measured: Day: 14
Angle
Angle (°) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions
Measured: Day : 14
Perceived fatigue
Perceived fatigue will be assessed by the Rated Perceived Exertion (RPE) scale before and after 6MWT. The RPE scale runs from 0 - 10. 0 is related to an easy activity and 10 (very, very heavy) is related to a very difficult activity.
Measured: Day : 14
Power
Power (watt) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions
Measured: Day : 14
Momentum
Momemtum (J rad-1) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions
Measured: Day : 14
Satisfaction related to the device
A satisfaction survey will be asked in order to assess the positioning of AFO, comfort, esthetic and global satisfaction of devices
Measured: Day : 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start7 Sep 2020
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis;Poststroke/CVAStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, cross-over, open labelled, monocentric, controlled trial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital of Saint-Etienne
- Responsible party
- Sponsor
- Investigators
- Paul Calmels, MD,PhD, Principal investigator, CHU Saint Etienne, Bellevue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323943
- Sponsor's protocol ID
- EC28
- Other IDs
- ANSM
- Acronym
- MECASPRY
- Status last verified
- Jan 2022
- First submitted
- 19 Mar 2020
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
- ClinicalTrials.gov ID
- NCT04323943
- Acronym / sponsor ID
- MECASPRY / EC28
- Conditions
- Hemiparesis;Poststroke/CVA, Gait, Hemiplegic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital of Saint-Etienne
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 27 Mar 2020 (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.
Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. This impairment, termed as "foot drop", is caused by an association of weak dorsiflexors and increased spasticity and stiffness of the plantar-flexors. As a consequence, walking performances are reduced and energy cost of walking is deteriorated. This may increase performance fatigability, as the locomotion will be realized at a higher percentage of the subjects' capacities. In order to overcome these issues, different treatments are proposed. One of the most conventional solutions are the use of ankle foot orthosis (AFO) and it is the most commonly prescribed device used to compensate for "foot drop". There is a very large choice of AFO on the market which can be proposed to patients with foot drop.
The aim of this study is thus to assess the mechanical effects of using a manufactured carbon AFO in by comparison to a custom-made thermo-plastic AFO on walking capacity (distance and energy cost), fatigue and "foot drop" control throughout the gait phase in patients with hemiparetic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, cross-over, open labelled, monocentric, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Carbon-AFO (C-AFO) | Experimental | Device: Ankle Foot orthosis (AFO)Manufactured carbon ankle foot orthosis (C-AFO) Sprystep (Thuasne) will be provided to patients. A familiarization with C-AFO will be performed before doing the tests. |
| Custom-made thermo-plastic orthosis (CM-AFO) | Active comparator | Device: Ankle Foot orthosis (AFO)Own custom-made thermo-plastic orthosis (CM-AFO) of patients. A familiarization will be performed also before doing the tests. |
| Without orthosis (NO) | No intervention | –No orthosis - patient will wear only their shoes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hemiparetic patients, walking with CM-AFO
- Diagnosis of a first stroke since at least 6 months with medical conditions of stroke known, treatment proposed, cardio-vascular and neurological state stabilized
- Foot drop observed during the swing phase of gait, requiring the use of a custom-made plastic orthosis that has been used for at least 3 months and used for less than 2 years
- Muscle spasticity not higher than grade 3 according to the Modified Ashworth Scale
- Sufficient motor ability and endurance to ambulate at least 15 m independently without AFO
Key exclusion criteria (11 listed)
- Patients who did not have brain MRI imaging after their stroke to confirm the diagnosis of stroke,
- Patients with an associated cerebellar syndrome,
- Patients with clinical brainstem involvement (cranial pair deficit),
- Patients with a neurological history other than stroke that has an impact on walking,
- Patients with unstable cardiovascular or respiratory disorders likely to induce gait disorders that may influence the performance of the tests to a greater extent than in the case of vascular hemiplegics,
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 |
|---|---|---|
| Ankle Foot orthosis (AFO)Also: Sprystep (Thuasne)The experimental protocol will require 4 visits: one inclusion visit and 3 visits for evaluations. Each visit corresponds to one condition: C-AFO, CM-AFO or NO (according to a random order). Visit #1 will consist in a clinical evaluation and a familiarization session with the measuring devices and methodologies used in visit#2 #3 and #4. During #2, #3 and #4 visits (14 days between each session), the subject will perform with C-AFO, CM-AFO or NO according to the random order : * 5 x 15m overground at a comfortable walking speed (CWS) where EMG, ground reaction force and kinematics will be measured * 6MWT where energy cost will be measured * 5 x 15m overground (immediately after the 6MWT) at a comfortable walking speed | Device | Carbon-AFO (C-AFO), Custom-made thermo-plastic orthosis (CM-AFO) |
Primary outcome
Distance walked during the 6 Minute Walk Test (6MWT)
Time frame: Day : 14
Patient will performed three experimental session (14 days between each session) during wich the primary outcome will be assessed : one session while walking with C-AFO, one session while walking with CM-AFO, and one session while walking without AFO (randomized order). 6 Minute Walk Test is a beneficial tool to evaluate walking endurance in patients with poststroke hemiparesis
7 secondary outcomes
Energy cost
Time frame: Day : 14
Muscular activity
Time frame: Day: 14
Angle
Time frame: Day : 14
Perceived fatigue
Time frame: Day : 14
Power
Time frame: Day : 14
Momentum
Time frame: Day : 14
Satisfaction related to the device
Time frame: Day : 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Paul Calmels, MD,PhD principal investigator
CHU Saint Etienne, Bellevue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Foot orthosis (AFO) in people with Hemiparesis;Poststroke/CVA and Gait, Hemiplegic, run by Thuasne 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distance walked during the 6 Minute Walk Test (6MWT) (time frame: Day : 14). 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 11 Jan 2022.