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Enrolling by invitation Observational

Effect of Treatment Dairy for Spasticity

NCT03384927 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2017-12-11
Last updated
2025-04-23

Condition(s) studied

Spasticity, Muscle

Study 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 patient finds it easier to evaluate the treatment and, if necessary, set new goals.
3. To assess whether the patient's quality of life is increased by the use of the treatment diary.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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 during the study period, the participant will be withdrawn from the study.

Primary outcome measure(s)

  • Patient becomes more satisfied with their treatment using the treatment diary — October 2019
    To assess if the patient becomes more satisfied with their treatment using the treatment diary. This is assessed by a change in the score on the treatment assessment questionnaire (Questionnaire 1).

Trial sites (1)

FacilityCityRegionStatus
Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup Glostrup Municipality Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03384927 on ClinicalTrials.gov ↗ ← All trials in Denmark