💬In plain words
What the trial is, and whether it could suit you
Background Effective management of spasticity, a debilitating and challenging condition afflicting many recovering from and living with neurological conditions, may reduce long term consequences such as limb contracture, skin breakdown, compromised mobility, caregiver burden and discomfort. In rehabilitation, spasticity represents a significant barrier to successful rehabilitation outcomes. Effective spasticity management can increases the length of individual functional status, reduces equipment/care needs, hospital admissions and extends the time people can stay safely at home, which would represent an economic benefit to the health system. Extra-corporeal Shock Wave Therapy (ESWT), an intense short energy wave delivered directly at the region of affected muscles has, in past randomized controlled studies, demonstrated positive outcomes for this population (spastic stroke population, T
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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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