HemiplegiaGONIOSEFNCT04381546
FES-induced Muscular Control of the Knee on Balance and Gait Retraining After a Stroke or a Cerebral Injury
A study testing Functional Electrical Stimulation FES in people with Hemiplegia and Gait, Hemiplegic, run by Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie at 1 site in France.
Trial summary
The main hypothesis of the present study is that a safer knee joint is likely to encourage post stroke patients at an early stage to rely on their hemiparetic leg and transfer their weight onto it while walking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia, Gait, Hemiplegic, Gait, Unsteady
- What is being tested?
- Functional Electrical Stimulation FES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2018to 30 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = 18 years
- Cerebral injury or stroke
- Interval time since the onset of the neurological event: min 8 weeks (in case of an acute cerebral damage) or at a any time in case of a chronic affection
- Surface electrical stimulation of quadriceps and hamstrings possible
- Free range of motion in lower limbs
- Ankle-foot orthosis, dynamic or static
- Limited perimeter distance < 50 meters with or without walking technical aids
Who cannot join
- Knee-Ankle-Foot orthosis is required
- Body mass index > or = 30
- Thrombophlebitis
- Muscular pathology
- Unstable Cardio-Vascular pathology
- Lower limb prosthesis
Show all 12Show fewer
- Unstable seizures
- Orthostatic hypotension
- Recent fracture in lower limbs (<12 months)
- Pacemaker
- Pregnancy
- Betablockers
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
Menucourt, 95180
About this study
Official title: Projet GonioSEF: Etude de faisabilité d'un Dispositif d'amélioration du défaut de Report d'Appui Pendant la Marche en Phase Portante Chez Des Sujets présentant Une Atteinte du système Nerveux Central
The main hypothesis of the present study is that a safer knee joint is likely to encourage post stroke patients at an early stage to rely on their hemiparetic leg and transfer their weight onto it while walking. The main purpose of the present work is to assess the feasibility of FES-induced muscular control of the hemiplegic knee joint in order to improve stance phase support symmetry recovery in individuals with post stroke hemiplegia. Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb based on the real-time estimation of the knee angle and support phase.
Read the detailed description
The process of gait recovery in patients with severe post-stroke hemiplegia requires a significant investment and effort for both the patient and the therapist and is not always leading to a safe and autonomous gait. Increasing the chances for the patients of regaining a functional walking gait within limited timeframes is a challenge. Several studies have focused their attention on the neurological foot in the chronic phase because a poorly controlled foot dorsiflexion is a factor limiting gait recovery and increasing fall risk. Functional Electrical Stimulation (FES) can be used as an alternative to an orthosis to restore walking by activating paralyzed muscles. FES has been extensively studied to correct drop foot by activating foot dorsiflexors or inducing a withdrawal reflex.
Few studies have considered knee joint which has a major role, especially for the quality of the support, and this over the entire cycle of walking. In the initial phase after stroke, ensuring a safe knee control remains difficult because of the associated disorders including the lack of proprioceptive feedback. Classical observed disorders in this population are knee hyperextension during the stance phase (genu recurvatum) and flexed knees (crouch gait). Fixed orthoses are usually used to prevent this by limiting knee flexion or extension over the gait. FES is also an alternative to produce appropriately timed knee flexion or extension. Bioness L300 Plus© device proposes a thigh cuff embedding electrodes stimulating the quadriceps muscles to extend knee at the appropriate time during gait based on shank angle observation. Previous studies have investigated the contribution of quadriceps and gluteus maximus stimulation in improving standing balance and weight transfer or hamstrings stimulation associated to foot dorsiflexors stimulation in improving gait performance.
One of the main objectives of an early rehabilitation is to encourage patients with hemiplegia to rely on their paretic leg and to transfer their weight onto it while walking. Depending on the gait phase, the knee extension and flexion are restricted to a safety range by the adaptive delivery of quadriceps and hamstring electrical stimulation. A sensor network detects gait phases and knee angle evolution from which stimulation levels are modulated.
- Conditions
- Hemiplegia, Gait, Hemiplegic, Gait, Unsteady, Rehabilitation
- Being tested
- Functional Electrical Stimulation FES
- Medical subject headings
- Hemiplegia, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical Stimulation FESOther
Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb in patients with hemiplegia. It is based on the real-time estimation of the knee angle and support phase during gait.
| Study group | Role | What they receive |
|---|---|---|
| FES in patients with hemiplegia | Experimental | Patients will be equipped with 5 inertial measurement units. Two wireless bluetooth pressure insoles will be connected to the Raspberry. Electrical stimulation will be delivered via a wireless stimulator to the quadriceps and hamstrings via surface electrodes. Insoles will be used to online analyze Paretic Foot Support to discriminate between stance and swing phases. Stimulation will also be delivered just before initial contact at the end of swing phase. In stance phase, stimulation will be triggered either to quadriceps or hamstrings, depending on the paretic knee angle estimation relatively to the knee angle setpoint defined by the practitioner as the optimal flexion during stance phase (around 5°). Receives: Other: Functional Electrical Stimulation FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assymetry of stance phase
symmetry ratio of stance duration between paretic and non-paretic limbs
Measured: 24 hours
Assymetry of weight support in stance phase
percentage of weight supported during stance phase relatively to the total weight
Measured: 24 hours
Secondary outcomes (4)
Comfortable walking speed
The preferred walking speed at which the participant choose to walk and speed at which there is least energy consumption per unit distance
Measured: 24 hours
Cadence
The total number of full cycles on a 10m walking path
Measured: 24 hours
Physiological Cost Index (PCI)
Energy cost in walking. PCI is the ratio of the difference in working and resting mean heart rates (bpm) and the self-selected (comfort) walking speed (m/min). The PCI value reflects the energy expenditure for walking and is expressed as heartbeats per meter.
Measured: 24 hours
Borg score of the exercise intensity
Rating of perceived exertion while walking. Perceived effort of walking using a Borg scale from 6 (no exertion) to 20 (maximum exertion) evaluated by the participant.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start26 Apr 2018
- Primary completion30 Apr 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Responsible party
- Sponsor
- Investigators
- Charles Fattal, MD, PhD, Principal investigator, Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381546
- Sponsor's protocol ID
- 2017-A03611-52
- Acronym
- GONIOSEF
- Status last verified
- May 2020
- First submitted
- 16 May 2018
- Last updated
- 11 May 2020
- 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 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Projet GonioSEF: Etude de faisabilité d'un Dispositif d'amélioration du défaut de Report d'Appui Pendant la Marche en Phase Portante Chez Des Sujets présentant Une Atteinte du système Nerveux Central
- ClinicalTrials.gov ID
- NCT04381546
- Acronym / sponsor ID
- GONIOSEF / 2017-A03611-52
- Conditions
- Hemiplegia, Gait, Hemiplegic, Gait, Unsteady, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Centre de Rééducation et Réadaptation Fonctionnelle La ChâtaigneraieUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 11 May 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.
The main hypothesis of the present study is that a safer knee joint is likely to encourage post stroke patients at an early stage to rely on their hemiparetic leg and transfer their weight onto it while walking. The main purpose of the present work is to assess the feasibility of FES-induced muscular control of the hemiplegic knee joint in order to improve stance phase support symmetry recovery in individuals with post stroke hemiplegia. Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb based on the real-time estimation of the knee angle and support phase.
Detailed description
The process of gait recovery in patients with severe post-stroke hemiplegia requires a significant investment and effort for both the patient and the therapist and is not always leading to a safe and autonomous gait. Increasing the chances for the patients of regaining a functional walking gait within limited timeframes is a challenge. Several studies have focused their attention on the neurological foot in the chronic phase because a poorly controlled foot dorsiflexion is a factor limiting gait recovery and increasing fall risk. Functional Electrical Stimulation (FES) can be used as an alternative to an orthosis to restore walking by activating paralyzed muscles. FES has been extensively studied to correct drop foot by activating foot dorsiflexors or inducing a withdrawal reflex.
Few studies have considered knee joint which has a major role, especially for the quality of the support, and this over the entire cycle of walking. In the initial phase after stroke, ensuring a safe knee control remains difficult because of the associated disorders including the lack of proprioceptive feedback. Classical observed disorders in this population are knee hyperextension during the stance phase (genu recurvatum) and flexed knees (crouch gait). Fixed orthoses are usually used to prevent this by limiting knee flexion or extension over the gait. FES is also an alternative to produce appropriately timed knee flexion or extension. Bioness L300 Plus© device proposes a thigh cuff embedding electrodes stimulating the quadriceps muscles to extend knee at the appropriate time during gait based on shank angle observation. Previous studies have investigated the contribution of quadriceps and gluteus maximus stimulation in improving standing balance and weight transfer or hamstrings stimulation associated to foot dorsiflexors stimulation in improving gait performance.
One of the main objectives of an early rehabilitation is to encourage patients with hemiplegia to rely on their paretic leg and to transfer their weight onto it while walking. Depending on the gait phase, the knee extension and flexion are restricted to a safety range by the adaptive delivery of quadriceps and hamstring electrical stimulation. A sensor network detects gait phases and knee angle evolution from which stimulation levels are modulated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| FES in patients with hemiplegia | Experimental | Other: Functional Electrical Stimulation FESPatients will be equipped with 5 inertial measurement units. Two wireless bluetooth pressure insoles will be connected to the Raspberry. Electrical stimulation will be delivered via a wireless stimulator to the quadriceps and hamstrings via surface electrodes. Insoles will be used to online analyze Paretic Foot Support to discriminate between stance and swing phases. Stimulation will also be delivered just before initial contact at the end of swing phase. In stance phase, stimulation will be triggered either to quadriceps or hamstrings, depending on the paretic knee angle estimation relatively to the knee angle setpoint defined by the practitioner as the optimal flexion during stance phase (around 5°). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > or = 18 years
- Cerebral injury or stroke
- Interval time since the onset of the neurological event: min 8 weeks (in case of an acute cerebral damage) or at a any time in case of a chronic affection
- Surface electrical stimulation of quadriceps and hamstrings possible
- Free range of motion in lower limbs
Key exclusion criteria (12 listed)
- Knee-Ankle-Foot orthosis is required
- Body mass index > or = 30
- Thrombophlebitis
- Muscular pathology
- Unstable Cardio-Vascular pathology
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 |
|---|---|---|
| Functional Electrical Stimulation FESFunctional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb in patients with hemiplegia. It is based on the real-time estimation of the knee angle and support phase during gait. | Other | FES in patients with hemiplegia |
Primary outcome
Assymetry of stance phase
Time frame: 24 hours
symmetry ratio of stance duration between paretic and non-paretic limbs
Assymetry of weight support in stance phase
Time frame: 24 hours
percentage of weight supported during stance phase relatively to the total weight
4 secondary outcomes
Comfortable walking speed
Time frame: 24 hours
Cadence
Time frame: 24 hours
Physiological Cost Index (PCI)
Time frame: 24 hours
Borg score of the exercise intensity
Time frame: 24 hours
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 May 2020.
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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.
Charles Fattal, MD, PhD principal investigator
Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation FES in people with Hemiplegia and Gait, Hemiplegic, run by Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie 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 12 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 May 2020. 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?
Assymetry of stance phase (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 May 2020.