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Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study

RecruitingNAAges 18 Years - anyAllVastra Gotaland Region
NCT06733025 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Spasticity is a common complication following central nervous system injuries. Left untreated, spasticity can lead to various complications, hindering activities of daily living and diminishing independence. Spasticity affecting the hand is particularly debilitating because it prevents prehension and grasp, which are critical factors for the ability to perform activities of daily living independently. Spasticity is described as one of the prominent secondary conditions in individuals with various disabilities. While Botulinum toxin(BoNT) injections are widely used for focal spasticity, surgical interventions remain underutilized despite promising long-term outcomes. Center for Advanced Reconstruction of Extremities(C.A.R.E), at the hand surgery department at Sahlgrenska University hospital in Gothenburg, Sweden is a multiprofessional team and advocates a stratified surgical algorithm ba

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 18 years or above 2. Problematic spasticity, characterised by a velocity-dependent increase in tonic stretch reflexes or intermittent or sustained involuntary muscle activity in the UL after stroke, TBI, or SCI 3. Patients treated at least 6 months after the injury event 4. Ongoing BoNT treatment in the UL 5. A minimum of 3 months passed since the last BoNT injection 6. At least two muscles in the hand and wrist were considered for treatment 7. For the BoNT group, a community occupational or physical therapist was assigned for post BoNT treatment 8. For the surgery group, medically stable to undergo surgery 9. No other severe UL injuries affecting the functional level Exclusion Criteria: \-
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What it tests

  • Tendon lengthening surgery
  • BoNT Injections
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Where

1 site
Sahlgrenska University Hoispital
Mölndal, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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