Clinical trial NCT04800601: Walking Ankle isoKinetic Exercise
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Rehabilitation
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Walking speed
timeFrame: Week 6
Secondary outcomes:
measure: Social participation
timeFrame: Week 26, Week 52
measure: Walking spatio-temporal parameters
timeFrame: Week 0, Week 6, Week 26, Week 52
measure: Walking speed
timeFrame: Week 26, Week 52
measure: Dorsiflexors strength
timeFrame: Week 26, Week 52
measure: Use of technical aids to walk and the number of fall
timeFrame: Week 52
measure: Correlations between walking speed /dorsiflexor muscles strength
timeFrame: Week 0, Week 6, Week 26, Week 52
Other outcomes:
Locations:
city: Bidart
country: France
facility: Reeducation Institute Les Embruns
city: Bordeaux
country: France
facility: University Hospital
city: Brive-la-Gaillarde
country: France
facility: DUBOIS Hospital
city: Limoges
country: France
facility: University Hospital
city: Marseille
country: France
facility: University Institute of Rehabilitation Valmante Sud
city: Noth
country: France
facility: Functional rehabilitation center
city: Poitiers
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Jean-Christophe DAVIET
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.