Actively Recruiting
Does Extra-corporeal Shock Wave Therapy Combined With Botulinum Toxin Type A Treatment Improve Clinical and Patient Reported Outcomes When Compared to Standard Management (BoNTA) in Patients With Upper Limb Spasticity of Cerebral Origin?
Led by University of Alberta · Updated on 2026-04-13
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of adding Extra-corporeal Shock Wave Therapy (ESWT) to Botulinum Neurotoxin Type A (BoNTA) treatment for people with upper limb spasticity caused by brain injuries such as stroke, traumatic brain injury, or cerebral palsy. Spasticity is a challenging condition that affects movement and quality of life. This pilot study aims to compare clinical and patient-reported outcomes between combined ESWT and BoNTA treatment and BoNTA treatment alone to explore potential improvements in spasticity management. The study involves two groups: one receiving standard care with BoNTA injections plus a sham ESWT treatment that mimics the device sounds without delivering shockwaves, and the other receiving BoNTA plus actual ESWT using a specialized device delivering high-intensity shockwaves to the affected upper limb muscles. Treatments will be delivered over several visits at a specialized spasticity clinic. The study is randomized and placebo-controlled, with 20 participants in each group. Participants will attend 10 to 11 study visits for treatment, assessments, and data collection including patient-reported spasticity and pain scales, quality of life questionnaires, and physical measurements of muscle stiffness and joint range of motion at baseline and at 4, 12, and 24 weeks after treatment. Researchers will monitor safety, treatment adherence, and any adverse events throughout the study, aiming to better understand the benefits and feasibility of combining ESWT with BoNTA in managing upper limb spasticity.
CONDITIONS
Brief Title
Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults over 18 years with upper limb spasticity caused by brain injury such as stroke, traumatic brain injury, or cerebral palsy
- Female participants must be post-menopausal, sterilized for at least 12 months, or using highly effective contraception and willing to provide a pregnancy test
- Must be new to shockwave therapy
- Spasticity must have a Modified Ashworth Scale score of 2 at the elbow joint
- Must be willing to participate and provide written consent
- Must have the cognitive ability to complete simple questionnaires
- Either currently receiving Botulinum Neurotoxin Type A treatment with a 3-month washout or intending to begin standard BoNTA treatment for the affected arm
You will not qualify if you...
- Known neurodegenerative spinal disorders or spinal cord lesions
- Fixed joint contracture preventing assessment or a Modified Ashworth Scale score of 4
- Lower motor neuron damage in the affected limb
- Previous surgery on the affected arm affecting assessment
- Changes in oral or injected medications within one month before screening
- Changes in medications for depression within one month before screening
- Changes in rehabilitation therapy during the study
- Pregnancy or nursing
- Female of childbearing age without effective contraception or unwilling to take a pregnancy test
- Implanted electronic devices in the treatment area
- Taking Warfarin with poorly controlled bleeding risk or INR above 3
- Any cancer diagnosis
- Active infection, inflammation, open wounds, or swelling in the treatment area
- Participation in another clinical study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 6 months
Participants receive Botulinum Neurotoxin Type A (BoNTA) injections along with either actual extra-corporeal shock wave therapy (ESWT) or a sham ESWT treatment to their upper limb spasticity. This phase includes treatment and assessments.
10 to 11 visits for treatment, assessment, and data collection
Duration - Up to 24 weeks from baseline
Participants are monitored for changes in spasticity, range of motion, and quality of life up to 24 weeks after baseline treatment.
Visits at weeks 4, 12, and 24 for outcome assessments
Trial Site Locations
Total: 1 location
1
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada, T5G 0B7
Actively Recruiting
Research Team
S
Steacy Wray, RN
B
Benoit Martin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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