Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

Table 1 Study schedule

Time point	Screening < 2 weeks	Baseline Day 0	Visit 3 Month 1¹	Visit 4 Month 3²	Visit 5 Month 6	Visit 6 Month 9	Visit 7 Month 12²
Informed consent	X
Record demographics & handedness	X
Review inclusion/exclusion criteria	X	X
Review medical history	X	X
Details of stroke	X
Pre stroke function (inc Oxford Handicap Scale⁾)	X
Abbreviated Mental Test Score (AMTS)	X
Sheffield Aphasia Screening Test	X
Action Research Arm Test (ARAT)	X	X	X	X			X
Motricity Index		X	X	X			X
Grip strength		X	X	X			X
Nine Hole Peg Test		X	X	X			X
Modified Ashworth Scale	X	X	X	X			X
Self rating of severity		X	X	X			X
Upper limb pain (numerical rating scale)³		X	X	X			X
Patient selects upper limb goals		X
Review upper limb goal attainment			X
Barthel ADL Index³	X		X³	X³			X³
Quality of life – Stroke Impact Scale³	X		X³	X³			X³
Quality of life – Euroquol-5D³	X		X³	X³			X³
Resource utilisation questions³	X		X³	X³			X³
Pregnancy test⁴		X		X⁶	X⁶	X⁶
Randomisation		X
Treatment with Dysport⁵		X		X⁷	X⁷	X⁷
Commencement of 4 week upper limb therapy programme		X		X⁷	X⁷	X⁷
Clinical assessment by study therapist		X		X	X	X	X
Concomitant medications (inc anti-spasticity treatment)	X	X	X	X			X
Adverse Events		X	X	X			X
Participants views and experience			X				X

1. Visit window is +3 days.
2. Visit window is +5 days.
3. Questionnaires will be sent to the participant for completion 1 week prior to the visit. Participants will bring completed forms to the visit.
4. For female participants at risk of pregnancy.
5. Participants in the intervention group only.
6. Pregnancy test to be performed prior to any additional botulinum toxin injections.
7. Additional botulinum toxin injections/upper limb therapy to be provided if clinically appropriate

ISSN: 1745-6215