Status:
ENROLLING_BY_INVITATION
Effect of Treatment Dairy for Spasticity
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Spasticity, Muscle
Eligibility:
All Genders
Brief Summary
1. Assessing whether the treatment diary can help optimize the overall treatment of patients. 2. To assess whether the patient finds the treatment diary useful and worth spending time on. Also if the ...
Detailed Description
Hypothesis: A treatment diary will increase the patient's awareness of which spasticity symptoms are significant and can enable the patients to evaluate the treatment more easily. This will result i...
Eligibility Criteria
Inclusion
- Patients must have received at least two previous treatments before inclusion, ie. with approx. 3 months apart, and it is assessed that the patients have good effect of the treatments in relation to the agreed treatment goals.
Exclusion
- Patients where changes are planned regarding their treatment for muscle overactivity during the study period.
- Patients where the disease is not stable and where it may have a major influence on the treatment effect of botulinum toxin treatment during the study period and where it can be difficult to set SMART (Specific, Measurable, Accepted, Realistic, Timed) goals.
- Patients who have previously been treated and have used a treatment diary in connection with the botulinum toxin treatment.
- Patients who can not collaborate on completing goals and evaluating treatment effect due to language or cognitive problems.
- Patients who at the same time are being treated with botulinum toxin in the bladder.
- If significant changes occur in the patient's health, which may involve new cancer, stroke, multiple sclerosis attack, etc. during the study period, the participant will be withdrawn from the study.
Key Trial Info
Start Date :
December 11 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03384927
Start Date
December 11 2017
End Date
December 30 2025
Last Update
April 23 2025
Active Locations (1)
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1
Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600