PrOMBiS

• Research type

  Research Study

• Full title

  A randomised, placebo controlled, double-blind, single centre, out-patient trial to investigate the functional benefit of botulinum toxin injections combined with physiotherapy treatment for spasticity of the upper limb after stroke

• IRAS ID

  15661

• Contact name

  David Werring

• Eudract number

  2009-009357-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Many stroke survivors have significant ongoing difficulties using their affected hand for everyday tasks. ??Letting go? of grasped objects is often described as being slow and effortful, most likely caused by over-activity of the muscles (increased tone) that bend the wrist and close the hand. We know that injecting muscles with botulinum toxin will decrease tone and relax the hand with benefit for "passive" activities performed by carers such as washing; but no studies have convincingly shown that this treatment can improve the "active" use of the hand. This might be because: - tests of arm function are used that are not always sensitive enough to measure small changes important to the ability of the individual;- clinical measures of muscle tone are often used as an outcome and these can lack sensitivity; - The intervention might not have been given to the people who can benefit most. We will address this using two new measures: 1) a detailed measure of how the hand is used in a functional task of placing a glass on a target and letting it go; 2) a specially developed motor to accurately measure the muscle tone (and in particular the tone that might be reduced by botulinum toxin injections). We will carry out a double-blind randomised controlled trial with subjects (n=30) more than 1 month post-stroke, randomised to treatment or placebo group. Participants will be given injections (toxin or placebo) followed by standardised, effective upper-limb physiotherapy. The study is powered to detect between-group differences in grasp release.In this way we will investigate whether or not the toxin can be effectively used to improve everyday use of the hand. We will identify indicators to predict who will benefit so that the treatment is used appropriately and people do not have ineffective and unnecessary injections.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  09/H0714/5

• Date of REC Opinion

  9 Mar 2009

• REC opinion

  Favourable Opinion