Spastic foot drop (speed- and force-dependent hypertonia) is one of the most common neuro-orthopaedic disorders following brain injury. It has a negative impact on walking and is closely linked to independence in activities of daily living. This disorder combines a deficit in muscle strength in the plantar flexors and extensors with pathological hypertonia of the plantar flexors, causing an imbalance in ankle flexion and resulting in equinus deformity of the foot. Botulinum toxin is the first-line pharmacological treatment for focal spasticity of neurological origin, and its effectiveness is directly linked to the quality and quantity of associated rehabilitation care. However, the associated rehabilitation protocols remain vague and are based on general recommendations combining: stretching of muscles and tendons, muscle strengthening of spastic muscles, their agonists and antagonists, and functional work. The standard rehabilitation protocol used in our centre will be detailed in the study protocol. The isokinetic dynamometer is an open-chain muscle strengthening tool that has the advantage of introducing a concept of reproducible assessment and rehabilitation. This reproducibility is difficult to guarantee with the rehabilitation techniques practised by a therapist, whose applied force and precision may vary from one session to another. We have therefore developed a sequential muscle strengthening protocol combining strengthening work - fatigue of the triceps surae followed by muscle strengthening work of the foot lifters. The aim of this work is to determine the effects of this protocol compared to conventional rehabilitation aimed at promoting the post-injection effects of botulinum toxin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Patients in group will undergo isokinetic rehabilitation therapy five times a week, Monday to Friday, combining physiotherapy, adapted physical activity (see standard rehabilitation protocol) and strengthening exercises on an isokinetic dynamometer.
Patients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.
Strength of the foot lifters
The strength of the foot lifters will be assessed by the maximum peak torque of the foot lifters at 60° (rPT 60°) measured using an isokinetic dynamometer. The primary endpoint is the change in rPT 60° between the value at inclusion and the value at the end of rehabilitation. This endpoint will be compared between the two arms.
Time frame: At the baseline, and after 1 month of rehabilitation course
rPT values
rPT values
Time frame: At the baseline, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
Peak torque resistance
Measured using an isokinetic dynamometer at different angular velocities.
Time frame: At the baseline, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
Measurement of the agonist/antagonist ratio
using the isokinetic dynamometer at different visits.
Time frame: At the baseline, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
The spasticity score measured
using the Modified Aschworth Scale and stretch reflex measurement at different visits.
Time frame: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection , after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
The distance covered during a 6-minute walk test and the walking speed measured during a 10-metre walk test at the various follow-up visits.
The distance covered during a 6-minute walk test and the walking speed measured during a 10-metre walk test at the various follow-up visits.
Time frame: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
The exercise tolerance score
Using the Borg scale
Time frame: Before the rehabilitation protocol, during the consultation for the botulinum toxin injection, after 1 month of rehabilitation course , after 3 month follow-up and after 6 month follow-up
Clinical improvement in spasticity,
which will be assessed by the doctor in charge of the patient
Time frame: After 3 month follow-up and after 6 month follow-up
Collect the number of adverse events
Collect the number of adverse events
Time frame: At the baseline, before the rehabilitation protocol, after 1 month of rehabilitation course, after 3 month follow-up and after 6 month follow-up
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