Impact of a Sequential Isokinetic Fatigue Protocol Followed by Ankle Strengthening After Botulinum Toxin Injection Into Spastic Plantar Flexors on Foot Lift Strength and Walking

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Victor Pauchet

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Isokinetic rehabilitation protocol.

    Procedure/Surgery

    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.

  • standard rehabilitation programme

    Procedure/Surgery

    Patients in group will undergo a standard rehabilitation programme five times a week, Monday to Friday, combining physiotherapy and adapted physical activity.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: standard rehabilitation protocolOther 1 intervention
Group B: isokinetic rehabilitation protocolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: