Effect of Treatment Dairy for Spasticity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spasticity, Muscle. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Treatment Dairy on Botulinum Toxin Treatment for Muscle Overactivity (Spasticity). A Randomised Cross-over Study.
Overview
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.
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 in more relevant treatment goals. At the same time the treatment can be better addressed to the individual patient at routine controls. In addition, the treatment diary will result in closer cooperation between the physiotherapists and occupational therapists and the physician who administers the botulinum toxin. This collaboration is expected to lead to better common goals and optimization of treatment.
Finally, it is expected that the above will help to increase the patient's quality of life.
Primary outcome measures
- Patient becomes more satisfied with their treatment using the treatment diary [Time frame: October 2019]
Secondary outcome measures (2)
- To assess if the patient's quality of life is improved using the treatment diary. [Time frame: October 2019]
- The patients' assessment of the treatment diary will be described (Questionnaire 3). [Time frame: October 2019]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
Denmark · 1 center
- Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup — Glostrup Municipality
Identifiers
NCT: NCT03384927 · RH-2017-292