NCT06733025 Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study
| NCT ID | NCT06733025 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Muscle Spasticity |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2029-01-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-01-07 with a primary completion date of 2029-01-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 based on residual motor function, aiming to optimize patient outcomes. This open-label, non-randomized, paired study aims to compare the efficacy of spasticity-correcting upper limb surgery with BoNT injections in improving body function, activity, and participation in patients with upper limb spasticity. A total of 30 patients will undergo both interventions sequentially, allowing for within-patient comparisons. The sample size calculation is based on prior studies. All patients with ongoing BoNT treatment who get referral to C.A.R.E and seem eligible for the study will be informed about the study and enrolment procedure. Eligible participants will undergo both treatments sequentially, with outcome assessments conducted before and after each intervention. The treatments will follow routine clinical care. The primary outcome measure, Modified Ashworth Scale, will assess spasticity severity. Secondary outcomes will include measures of functional and activity changes specific to each treatment regimen. This study aims to provide valuable insights into the comparative effectiveness of spasticity interventions, guiding treatment decisions for patients with upper limb spasticity.
Eligibility Criteria
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: \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06733025 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Muscle Spasticity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06733025 currently recruiting?
Yes, NCT06733025 is actively recruiting participants. Contact the research team at therese.ramstrom@vgregion.se for enrollment information.
Where is the NCT06733025 trial being conducted?
This trial is being conducted at Mölndal, Sweden.
Who is sponsoring the NCT06733025 clinical trial?
NCT06733025 is sponsored by Vastra Gotaland Region. The trial plans to enroll 30 participants.