Walking Ankle isoKinetic Exercise (WAKE)

University of Limoges (UL)

Status

Enrolling

Conditions

Stroke Rehabilitation

Treatments

Other: Rehabilitation program 2

Other: Rehabilitation program 1

Study type

Interventional

Funder types

Other

Identifiers

NCT04800601

87RI20_0010 (WAKE)

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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