Status:
UNKNOWN
Does ESWT With BoNTA Treatment Improve Outcomes When Compared to Standard Management for Upper Limb Spasticity Patient.
Lead Sponsor:
University of Alberta
Conditions:
Spasticity, Muscle
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Study Setting The study will be performed within the Adult Spasticity Clinic at the Glenrose Rehabilitation Hospital (GRH) in Edmonton city in Canada. This is a dedicated space, appropriately equippe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05226637
Start Date
April 29 2022
End Date
December 1 2025
Last Update
December 12 2023
Active Locations (1)
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1
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada, T5G 0B7