NCT03910101Completed
Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
Spasticity - a variety of motor over-activity and part of the upper motor neuron syndrome - is a common cause of impaired motor function after brain injuries of different etiologies. In addition, it may cause pain and impaired hygiene, contractures, deformities etc. Spasticity has been reported in 30 to 90% of patients with stroke, traumatic brain injury (TBI), incomplete spinal cord injury (SCI) and cerebral palsy (CP). Spasticity therapy has emerged as an important approach to alleviate related symptoms. Positive effects on spasticity are well recognized following systemic and intra-thecal pharmacological treatment, as well as after intra-muscularly injected substances; the effect of the latter is, however, of limited duration. While pharmacological spasticity therapy has been applied for decades, surgical procedures remain fairly uncommon in adults with spasticity, but not in pediatric patients with CP, and outcomes after surgical treatment are scarcely described in the literature. The study center is a specialized unit initially focused on reconstructive as well as spasticity reducing surgery in the upper extremities for SCI patients. Subsequently, patients with spasticity also due to various other Central nervous system diseases have been referred to the center for surgical treatment. Studies describing the effect of spasticity-reducing surgery in the upper extremities are rare and the group is heterogeneous. The aim of the study is evaluating the long-term efficacy of spasticity-correcting surgery versus BoNT in patients with disabling UL spasticity. As a secondary aim, we want to compare the peak effects of the two treatments, Botulinum toxin injections and spasticity-correcting surgery.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 6 Mar 2019
- Start date
- 25 Jan 2019
- Primary completion date
- 25 Jun 2024
- Lead sponsor
- Vastra Gotaland Region
- Diseases
- Stroke
- NCT number
- NCT03910101
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 25 Jan 2019 to the primary completion date, 25 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Under the age of 18
Criteria the registry did not label
- The eligibility criteria for this study were as follows: 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; and 3. Patients treated at least 6 months after the injury event; and 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital, centrum for advanced reconstruction of extremities Coordinator of this site? Confirm its status | Mölndal | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.