Stroke RehabilitationWAKENCT04800601
Walking Ankle isoKinetic Exercise
A study testing Rehabilitation program 1 and Rehabilitation program 2 in people with Stroke Rehabilitation, run by University Hospital, Limoges at 7 sites in France.
Trial summary
This study is a multi-center, interventional, experimental, prospective, controlled and randomized study. We propose a reeducation protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening", limit the loss of strength associated with the functional loss and thus allow to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Rehabilitation
- What is being tested?
- Rehabilitation program 1 and Rehabilitation program 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesFrance
- Study dates
- 20 May 2021to 20 May 2026
- 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
- First stroke,
- Ischemic or hemorrhagic stroke hospitalized in MPR in sub-acute phase (15 days to 3 months)
- Persistent deficiency of foot lifts (Medical Research Council testing: MRC <5)
- Walking alone at least 10 meters with or without technical assistance
- Absence of pain in the lower limb (EVA <2)
Who cannot join
- Cognitive or phasic disorders that do not make it possible to understand the instructions: Boston Scale BDAE <2
- Gait disorder before stroke
- Fixed stiffness of the ankle (irreducible equine less than 30 °)
- Spasticity too important: Modified Ashworth (MAS) greater than or equal to 4.
- Pregnancy or desire for pregnancy, breastfeeding
- Patient under curatorship or guardianship or under the protection of justice
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 5 recruiting
- Terminated
Reeducation Institute Les Embruns
Bidart, 64210
- Active, not recruiting
University Hospital
Bordeaux, 33000
- Not yet recruiting
DUBOIS Hospital
Brive-la-Gaillarde, 19312
Sonia JEDDI, s.jeddi@hotmail.fr
Sonia Jeddi
- Recruiting
University Hospital
Limoges, 87042
Jean-Christophe DAVIET, Pr, + 33 5 55 05 65 38, jean-christophe.daviet@unilim.fr
Jean-Christophe DAVIET
- Recruiting
University Institute of Rehabilitation Valmante Sud
Marseille, 13009
Laurent BENSOUSSAN, Pr, + 33 4 88 22 86 99, Laurent.bensoussan@ap-hm.fr
Laurent BENSOUSSAN
- Not yet recruiting
Functional rehabilitation center
Noth, 23300
Alfredo MUSUMECI, alfredo.musumeci@fondationpartageetvie.org
Alfredo MUSUMECI
- Recruiting
University Hospital
Poitiers, 86021
Anne JOSSART, Dr, + 33 5 49 44 44 26, Anne.jossart@chu-poitiers.fr
Romain DAVID
About this study
Official title: Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: Experimental Interventional Study
This study is a multi-center, interventional, experimental, prospective, controlled and randomized study. We propose a reeducation protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening", limit the loss of strength associated with the functional loss and thus allow to reach a more effective walking activity. This should encourage social participation following discharge from the hospital. The main objective is to evaluate the impact of this 6 weeks program on walking speed.
Read the detailed description
According to HAS, stroke is the leading cause of disability acquired in France. If 90% of patients recover walking, it is often limited with a steady speed around 0.7m/s. This limitation of walking activity is partly related to a decrease in strength associated with more or less significant spasticity. In stroke, this decrease in strength is the result of central impairment. Rehabilitation therefore involves gestural repetition. Mentiplay's review (Mentiplay et al., 2015) showing the predominance of ankle muscle strength in walking activity, we propose a protocol based on repetitive mobilization of this joint during subacute phase to promote awakening control, to limit the loss of muscle strength and thus potentiate the recovery of a more efficient walking. The strength of this study would be to verify the effectiveness of such a program in a large number of patients (5 centers involved). Its originality is to measure the impact of this program on social participation.
The patients will be recruited in 5 centers during their hospitalization, in sub-acute phase. Two groups will be formed: a control group in conventional rehabilitation; an experimental group that will perform 5x/week 300 movements of plantarflexion, dorsiflexion on isokinetic dynamometer (in passive mode, with the intention of producing the greatest possible force). This protocol will take place over 6 weeks.
Follow-up visits will take place at the end of the 6th week (which corresponds to the end of the ankle rehabilitation protocol), 6 months and one year after the beginning of the protocol.
These visits will include a clinical examination, a GaitRite carpet walking test, an isokinetic evaluation of the ankle dorsiflexor muscles strength and a SIPSO self-administered questionnaire (social participation) at 6 months and one year.
- Conditions
- Stroke Rehabilitation
- Being tested
- Rehabilitation program 1, Rehabilitation program 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation program 1Other
Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking.
In addition to this conventional rehabilitation, the experimental group will receive an ankle isokinetic program, 5 times a week, for 6 weeks (with a minimum of 25 sessions)
Rehabilitation program 2Other
Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking.
The control group will have a supplement in conventional rehabilitation equal to the additional time of the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Other: Rehabilitation program 1 |
| Control group | Active comparator | Not described Receives: Other: Rehabilitation program 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
10 m walking speed measured at the end of intervention
Measured: Week 6
Secondary outcomes (6)
Social participation
Social participation will be analyzed by specific questionnaire, the Subjective Index of Physical and Social Outcome (SIPSO) at S26 (26th week) and S52 (52th week).
Measured: Week 26, Week 52
Walking spatio-temporal parameters
The parameters will be measured using a treadmill at each assessment (week 0, week 6, week 26, week 52) :
- the duration of support phase (ms),
- the duration of oscillating phase (ms),
- the cadence (steps/min),
- the step variability.
Measured: Week 0, Week 6, Week 26, Week 52
Walking speed
10m speed: measured at week 26 and week 52
Measured: Week 26, Week 52
Dorsiflexors strength
Dorsiflexors strength evaluated by isokinetic dynamometer at Week 0, Week 6, Week 26 and Week 52.
Measured: Week 26, Week 52
Use of technical aids to walk and the number of fall
The use of technical aids to walk and the number of falls will be listed in Week 52.
Measured: Week 52
Correlations between walking speed /dorsiflexor muscles strength
Correlations between walking speed /dorsiflexor muscles strength at Week 0, Week 6, Week 26 and Week 52 and walking speed/social participation at Week 26 and Week 52. (The dorsiflexor muscles strength will be evaluated by isokinetic dynamometer at Week 0, Week 6, Week 26 and Week 52. The walking speed over 10m will be measured at Week 0, Week 6, Week 26 and Week52. Social participation will be measured by questionnaire (SIPSO) at Week 26 and Week 52)
Measured: Week 0, Week 6, Week 26, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start20 May 2021
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe DAVIET, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800601
- Sponsor's protocol ID
- 87RI20_0010 (WAKE)
- Acronym
- WAKE
- Status last verified
- May 2024
- First submitted
- 8 Mar 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferry B, Compagnat M, Yonneau J, Bensoussan L, Moucheboeuf G, Muller F, Laborde B, Jossart A, David R, Magne J, Marais L, Daviet JC. Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial. Trials. 2022 Aug 16;23(1):661. doi: 10.1186/s13063-022-06545-w.
PubMed 35974379
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: Experimental Interventional Study
- ClinicalTrials.gov ID
- NCT04800601
- Acronym / sponsor ID
- WAKE / 87RI20_0010 (WAKE)
- Conditions
- Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 16 Mar 2021 (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.
This study is a multi-center, interventional, experimental, prospective, controlled and randomized study. We propose a reeducation protocol based on an early over-solicitation of the ankle dorsiflexor muscles to promote their "awakening", limit the loss of strength associated with the functional loss and thus allow to reach a more effective walking activity. This should encourage social participation following discharge from the hospital. The main objective is to evaluate the impact of this 6 weeks program on walking speed.
Detailed description
According to HAS, stroke is the leading cause of disability acquired in France. If 90% of patients recover walking, it is often limited with a steady speed around 0.7m/s. This limitation of walking activity is partly related to a decrease in strength associated with more or less significant spasticity. In stroke, this decrease in strength is the result of central impairment. Rehabilitation therefore involves gestural repetition. Mentiplay's review (Mentiplay et al., 2015) showing the predominance of ankle muscle strength in walking activity, we propose a protocol based on repetitive mobilization of this joint during subacute phase to promote awakening control, to limit the loss of muscle strength and thus potentiate the recovery of a more efficient walking. The strength of this study would be to verify the effectiveness of such a program in a large number of patients (5 centers involved). Its originality is to measure the impact of this program on social participation.
The patients will be recruited in 5 centers during their hospitalization, in sub-acute phase. Two groups will be formed: a control group in conventional rehabilitation; an experimental group that will perform 5x/week 300 movements of plantarflexion, dorsiflexion on isokinetic dynamometer (in passive mode, with the intention of producing the greatest possible force). This protocol will take place over 6 weeks.
Follow-up visits will take place at the end of the 6th week (which corresponds to the end of the ankle rehabilitation protocol), 6 months and one year after the beginning of the protocol.
These visits will include a clinical examination, a GaitRite carpet walking test, an isokinetic evaluation of the ankle dorsiflexor muscles strength and a SIPSO self-administered questionnaire (social participation) at 6 months and one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Rehabilitation program 1 |
| Control group | Active comparator | Other: Rehabilitation program 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First stroke,
- Ischemic or hemorrhagic stroke hospitalized in MPR in sub-acute phase (15 days to 3 months)
- Persistent deficiency of foot lifts (Medical Research Council testing: MRC <5)
- Walking alone at least 10 meters with or without technical assistance
- Absence of pain in the lower limb (EVA <2)
Key exclusion criteria (6 listed)
- Cognitive or phasic disorders that do not make it possible to understand the instructions: Boston Scale BDAE <2
- Gait disorder before stroke
- Fixed stiffness of the ankle (irreducible equine less than 30 °)
- Spasticity too important: Modified Ashworth (MAS) greater than or equal to 4.
- Pregnancy or desire for pregnancy, breastfeeding
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 |
|---|---|---|
| Rehabilitation program 1Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking. In addition to this conventional rehabilitation, the experimental group will receive an ankle isokinetic program, 5 times a week, for 6 weeks (with a minimum of 25 sessions) | Other | Experimental group |
| Rehabilitation program 2Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking. The control group will have a supplement in conventional rehabilitation equal to the additional time of the experimental group. | Other | Control group |
Primary outcome
Walking speed
Time frame: Week 6
10 m walking speed measured at the end of intervention
6 secondary outcomes
Social participation
Time frame: Week 26, Week 52
Walking spatio-temporal parameters
Time frame: Week 0, Week 6, Week 26, Week 52
Walking speed
Time frame: Week 26, Week 52
Dorsiflexors strength
Time frame: Week 26, Week 52
Use of technical aids to walk and the number of fall
Time frame: Week 52
Correlations between walking speed /dorsiflexor muscles strength
Time frame: Week 0, Week 6, Week 26, Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 35974379Ferry B, Compagnat M, Yonneau J, Bensoussan L, Moucheboeuf G, Muller F, Laborde B, Jossart A, David R, Magne J, Marais L, Daviet JC. Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial. Trials. 2022 Aug 16;23(1):661. doi: 10.1186/s13063-022-06545-w.
- Individual participant dataSharing planned: No
Related trials for Stroke Rehabilitation
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Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
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Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
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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.
Jean-Christophe DAVIET principal investigator
University Hospital, Limoges
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program 1 and Rehabilitation program 2 in people with Stroke Rehabilitation, run by University Hospital, Limoges at 7 sites 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 5 inclusion and 6 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 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Jean-Christophe DAVIET, Pr (+ 33 5 55 05 65 38, jean-christophe.daviet@unilim.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04800601, which also lists 1 linked publication.
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 29 May 2024.