Actively Recruiting
The Effectiveness of Spasticity-correcting Upper Limb Surgery Versus Botulinum Toxin Injections in Patients With Upper Limb Spasticity: an Experimental Study With Paired Design
Led by Vastra Gotaland Region · Updated on 2025-09-17
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
P
Promobilia Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for upper limb spasticity, a common complication after central nervous system injuries such as stroke, traumatic brain injury, or spinal cord injury. This condition can severely limit hand function and daily activities. The study compares the effects of spasticity-correcting surgery and Botulinum toxin (BoNT) injections to determine which treatment is more effective in improving body function, activity, and participation. The research uses an open-label, non-randomized, paired design involving 30 patients. Participants will first receive BoNT injections targeting spastic muscles in the upper limb. The dosage and number of muscles treated depend on the severity of spasticity and are determined by specialists. After at least three months to avoid carryover effects, participants will undergo spasticity-correcting tendon lengthening surgery. The surgical procedure involves lengthening affected tendons to restore muscle length and function, followed by a rehabilitation program including splinting and exercises. Both treatments follow routine clinical care protocols. Throughout the study, patients will be evaluated at multiple time points before and after each treatment. Assessments include the Modified Ashworth Scale to measure spasticity severity and various tests to evaluate hand function, range of motion, strength, activity level, and quality of life. Researchers will analyze changes in these measures to compare the treatments. The study aims to guide future treatment decisions and improve care for patients with upper limb spasticity over a total participation period that spans before and after both interventions.
CONDITIONS
Brief Title
Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or above
- Problematic upper limb spasticity caused by stroke, traumatic brain injury, or spinal cord injury
- At least 6 months have passed since the injury event
- Ongoing Botulinum toxin treatment in the upper limb
- At least 3 months passed since the last Botulinum toxin injection
- At least two muscles in the hand and wrist considered suitable for treatment
- Assigned a community occupational or physical therapist for post Botulinum toxin treatment
- Medically stable to undergo surgery
- No other severe upper limb injuries affecting functional level
You will not qualify if you...
- No exclusion criteria listed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 injection cycle with peak effect at 4-6 weeks and effect lasting about 3 months
Participants receive Botulinum toxin injections in spastic upper limb muscles as part of routine care, followed by standard rehabilitation including stretching, strength training, and possibly splinting.
Visits at baseline, 5 weeks, and 3 months after injection
Duration - At least 3 months
Participants wait at least three months after BoNT injections to rule out carryover effects before surgery.
No specific visits during this period
Duration - Surgery day plus 6 months of recovery and rehabilitation
Participants undergo tendon lengthening surgery to correct upper limb spasticity followed by post-operative care including splinting and rehabilitation exercises.
Visits at baseline before surgery and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Sahlgrenska University Hoispital
Mölndal, Sweden, 43180
Actively Recruiting
Research Team
T
Therese Ramström, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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