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
2008

Evaluating Botulinum Toxin for Upper Limb Spasticity After Stroke

Sample size: 332 publication Evidence: moderate

Author Information

Author(s): Helen Rodgers, Lisa Shaw, Christopher Price, Frederike van Wijck, Michael Barnes, Laura Graham, Gary Ford, Phil Shackley, Nick Steen

Primary Institution: Institute for Ageing and Health, Newcastle University

Hypothesis

The study aims to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in treating post-stroke upper limb spasticity.

Conclusion

The study will assess whether combining botulinum toxin with therapy improves upper limb function in stroke patients.

Supporting Evidence

  • Upper limb spasticity affects 55-75% of stroke patients long-term.
  • Botulinum toxin is increasingly used to treat focal spasticity.
  • Effective management of spasticity requires a multidisciplinary approach.

Takeaway

This study is trying to find out if a special medicine called botulinum toxin can help people who have trouble moving their arms after a stroke, especially when used with therapy.

Methodology

A multi-centre open-label parallel group randomised controlled trial comparing botulinum toxin type A plus upper limb therapy with upper limb therapy alone.

Potential Biases

Potential selection bias as participants were recruited from specialized centers rather than general stroke services.

Limitations

The study may not fully represent all stroke patients due to the exclusion of those with significant cognitive impairments.

Participant Demographics

Adults with upper limb spasticity due to stroke, aged over 18 years, with a stroke occurring more than 1 month prior.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-9-59

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