Clinical Trials Logo

Clinical Trial Summary

The addition of a self-rehabilitation program to repeated Botulinum Toxin Injections (BTI) and usual physiotherapy should increase the proportion of patients who attain their Primary Treatment Goal (impairments and function) more than usual care (involving repeated Botulinum Toxin Injections and conventional physiotherapy), in post stroke out-patients with spasticity.


Clinical Trial Description

Stroke affects 150 000 persons in France each year. Most patients have activity limitations because of the resulting motor deficit and spasticity. Autonomy in activities of daily living is reduced.

The principal treatment for focal spasticity is currently intramuscular botulinum toxin injection (BTI).

BTI is classically combined with only 2 to 3 sessions of out-patient physiotherapy per week. This is mainly because of a lack of out-patient therapists. However, this amount of therapy is insufficient and does not follow current literature which shows that the intensity of physiotherapy affects the recovery of impairment and activity. This gap in our health system could be filled by a self-rehabilitation program in addition to physiotherapy.

Recent studies have shown that self-rehabilitation following BTI could significantly improve activity limitation (Roche et al, 2014 ; Sun et al 2010).

The addition of a self-rehabilitation program to BTI and usual out-patient physiotherapy could thus increase the effects of BTI on impairment and activity limitation in patients with spastic hemiparesis following stroke. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02944929
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Nicolas Roche, MD
Phone + 33(1) 47 10 54 09
Email roche.nicolas@aphp.fr
Status Recruiting
Phase Phase 3
Start date January 1, 2018
Completion date January 3, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05436366 - Soleus Loading Response During Walking N/A
Completed NCT05546190 - A Study to Collect Participants Experience of Living With Adult Upper Limb (AUL) Spasticity and to Assess the Arm Activity Measure (ArmA)
Completed NCT03549975 - Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study Phase 4
Active, not recruiting NCT06001736 - Utility of CC7 Transfer in Stroke Subtypes N/A
Completed NCT02969356 - Study to Evaluate Effects of DYSPORT® Injected in Lower and Upper Limb Combined With Guided Self-Rehabilitation Contract (GSC) Phase 4
Recruiting NCT03402854 - tDCS and Bimanual Therapy for Children With Hemiplegic Cerebral Palsy N/A