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Enrolling by Invitation

NCT Number: NCT03384927

Effect of Treatment Dairy for Spasticity

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Patient becomes more satisfied with their treatment using the treatment diary

    Time frame: 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).

Secondary outcomes

  1. To assess if the patient's quality of life is improved using the treatment diary.

    Time frame: October 2019

    To assess if the patient's quality of life is improved using the treatment diary. This is assessed by a change in the score on the quality of life, SF-12 (Questionnaire 2)

  2. The patients' assessment of the treatment diary will be described (Questionnaire 3).

    Time frame: October 2019

    the patients' assessment of the treatment diary will be described (Questionnaire 3).

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Effect of Treatment Dairy on Botulinum Toxin Treatment for Muscle Overactivity (Spasticity). A Randomised Cross-over Study.

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Dec 28, 2017
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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