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Compares treatment options for Spasticity, Muscle
Official title Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.
ClinicalTrials.gov ID: NCT05226637
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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 people 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.