About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient
Patient with spastic hemiplegia (regardless of cause)
MAS 1-2 spasticity of the plantar flexors
Deficit of the foot lifters at the minimum stage of contraction with movement
Disqualifiers
Refusal of consent
Patient with severe cognitive impairment (MMSE <23/30)
Surgery on the affected lower limb
Patient unable to read, write or understand French
Trial design
Parallel
Treatments tested in this trial
Isokinetic rehabilitation protocol.
Procedure/SurgeryPatients 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.
standard rehabilitation programme
Procedure/SurgeryPatients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
rPT values
rPT values
Peak torque resistance
Measured using an isokinetic dynamometer at different angular velocities.
Measurement of the agonist/antagonist ratio
using the isokinetic dynamometer at different visits.
The spasticity score measured
using the Modified Aschworth Scale and stretch reflex measurement at different visits.
Locations
Sponsors and contacts
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