Shock wave combo could ease stiff muscles after stroke
NCT ID NCT05226637
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding extra-corporeal shock wave therapy (ESWT) to standard Botox injections improves muscle stiffness and quality of life in adults with upper limb spasticity caused by stroke, brain injury, or cerebral palsy. Forty participants will be randomly assigned to receive either Botox plus real ESWT or Botox plus a placebo treatment. Researchers will measure changes in stiffness, range of motion, and patient-reported outcomes over 24 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * People with upper limb Spasticity of Cerebral Origin, including but not limited to: * Acquired brain injury (of at least 1 year following the event); * Stroke; * Cerebral Palsy (CP); * Male and females over 18 years of age. * Female subjects must either be post-menopausal, sterilized (at least 12 months post menses) or be consistently using a highly effective method of birth control such as a sterilized partner, oral/implanted/injected contraception or abstinence of sexual activity and be willing to provide a pregnancy test as the safe use of ESWT during pregnancy has not been demonstrated. * Being naive to shockwave therapy; * Spasticity as defined by Modified Ashworth Scale (MAS) score of 2 in a functional or non-functional upper limb affecting the target joint, which for the purpose of the study will be the elbow; * Willingness to participate and provide written consent; * Have the cognitive capacity to answers simple questionnaires; * Either already receiving treatment with BoNTA and having been 'washed out' for a period of three months, or intends to begin 'standard treatment with BoNTA to an affected arm with target joint involvement. * Standard treatment in the context of the study will include, in addition to any other therapies, focal treatment with Botulinum Neurotoxin Type A to treat the target joint. Exclusion Criteria: * Known neurodegenerative disorder at the spinal level; * Known spinal cord lesion ; * Fixed contracture of target joint impeding assessment or MAS of 4; * Any demonstrated lower motor neuron damage to the affected limb; * Surgery received to affected arm that may affect assessment of the target joint; * Any changes in either oral or focally injected medications one month prior to screening to close out, that could influence any outcome measures; * Any changes in medication one month prior to screening to close out, for the treatment of depression as changes in patient affect may influence outcome measures; * Any changes in rehabilitation therapy throughout the study cycles; * Confirmed pregnancy. Safe use in this population remains unknown; * Nursing mothers. Safe use in this population remains unknown; * Female patients who are of childbearing age without adequate contraception and unwilling to take a pregnancy test; * Implanted electronic device/s. Kinetic energy in the same territory as an implanted device may adversely affect the device's function; * Patients taking Warfarin and have poorly controlled coagulopathy or an INR above 3 at the Point of Care. To avoid hematoma, compartment syndrome or other consequences of prolonged bleeding to treated area. This is also the same program criteria for injection with BoNTA. For this population INR will be determined (using the Coguchek XL device) prior to each treatment; * Any malignant diagnoses. Tissue disruption caused by the shockwave treatment may precipitate the liberation or shedding of cancer cells; * Any known infection, inflammatory process, open areas or acute undiagnosed swelling (acute being defined as 14 days or sooner) in the area treated to avoid worsening of any pre-existing condition; * Participation in any other concurrent study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Glenrose Rehabilitation Hospital
RECRUITINGEdmonton, Alberta, T5G 0B7, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- 500 stroke survivors help scientists unlock secrets of walking recovery
- Sound waves aim to calm spastic muscles in spinal injury patients
- Scientists hunt for genetic clues to rare paralysis disorder
- Spinal stimulation without surgery shows promise for spasticity relief
- Brain training may strengthen movement after spinal cord injury