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Shock wave combo could ease stiff muscles after stroke

NCT ID NCT05226637

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Recruiting now This study
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

Muscle Spasticity

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Glenrose Rehabilitation Hospital

    RECRUITING

    Edmonton, Alberta, T5G 0B7, Canada

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