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Ms Luci Crook


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Be Part of Research - Trial Details - Predicting Outcome and Measuring Benefit from botulinum therapy in Stroke
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Predicting Outcome and Measuring Benefit from botulinum therapy in Stroke

Not Recruiting

Open to: All Genders

Age: Not Specified

London

Medical Conditions

Topic: Stroke Research Network
Subtopic: Rehabilitation
Disease: Drug type, Therapy type, In hospital study

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


People with stroke often say they cannot use their affected arm and hand. There are many potential causes, but one problem likely to contribute is a type of muscle stiffness (spasticity). People with spasticity experience unwanted muscle activity, spasms and tightness or stiffness, making movement of the hand extremely difficult. Botulinum toxin is a purified protein derived from the bacteria Clostridium botulinum and is licensed in the UK for treating muscle spasticity after stroke. It works by blocking the signal from the brain to the muscle nerve endings in the area close to the injection site. The overactive muscle is temporarily paralysed (the effects wear off after about three months), providing a “window of opportunity” where physiotherapy may be more effective. We aim to investigate whether Botulinum toxin injections can help in less severe spasticity so that active functional use of the arm and hand can be improved. While there have been some reports of success from doctors and patients, there is no current definite proof that it works, so this expensive drug is not routinely offered. In total, we will be investigating 30 similar people with stroke.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

03 Jul 2009 31 Dec 2013

Publications

Results article in http://discovery.ucl.ac.uk/id/eprint/14598672020 Results article in https://pubmed.ncbi.nlm.nih.gov/31747825/ (added 23/04/2021)

To find out whether the botulinum toxin injections help, we will compare a group of people who are injected with botulinum toxin with another group who are injected with a water solution. The water solution looks like the genuine medicine, but has no active ingredient and so is called a placebo.
You will be randomly allocated to a botulinum toxin group or a placebo group and you have a 50% chance of being in either group. Neither you nor your doctor or physiotherapist will know which group you are in.
You will attend the National Hospital for Neurology and Neurosurgery for assessment and treatment over a period of four months.
On your first visit you will be assessed by a group of doctors and physiotherapists for suitability for the study. If you are suitable and decide to take part, you will be asked to sign a consent form and complete some baseline tests and questionnaires, before being given the injections into the muscles in your hand and arm.
You will then come for 10 physiotherapy sessions, spread over 4 weeks and each lasting around an hour. You will work on strengthening exercises for specific muscles and practice skilled hand tasks. You will also be expected to do some practice at home and to record this in a diary. After this, you will come a further three times for follow up assessments. Lastly, we will contact you three months after your last assessment visit to repeat the questionnaires by telephone or by post.
During the study you will not be able to take any new drugs for spasticity or increase the dose of any drugs you are already taking for spasticity.
You are free to refuse to take part or to withdraw from the study at any time without having to give a reason.



You may be able to participate if:
- You have had a stroke and have difficulty using your arm and hand.
- You are able to pick up, move, set down and let go of a cup (it doesn't matter if letting go is very slow or difficult).
- You are aged 18 years or older.
To enroll you will need to give your informed consent.

You can take part if:



You may not be able to take part if:


1. Orthopaedic impairments affecting the hemiplegic upper limb or spine2. Additional neurological impairment not related to stroke3. Shoulder or wrist pain (greater than 3 on a 0 - 10 visual analogue scale) whilst performing the experimental tasks4. Severe cognitive impairment preventing informed consent and/or the ability to follow task instructions5. Anti-coagulation with an international normalised ratio (INR) of greater than 2


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Institute of Neurology
    London
    WC1N 3BG

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Ms Luci Crook



The study is sponsored by University College London (UK) and funded by The Stroke Association (UK).



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Read full details for Trial ID: ISRCTN03624752

Or CPMS 5644

Last updated 23 April 2021

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