Effect of Treatment Dairy for Spasticity

Spasticity, Muscle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03384927
• Other study ID #: RH-2017-292
• Status: Enrolling by invitation
• Start date: December 11, 2017
• Est. completion date: October 30, 2024

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: October 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

Locations

Country	Name	City	State
Denmark	Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient becomes more satisfied with their treatment using the treatment diary	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).	October 2019
Secondary	To assess if the patient's quality of life is improved using the treatment diary.	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)	October 2019
Secondary	The patients' assessment of the treatment diary will be described (Questionnaire 3).	the patients' assessment of the treatment diary will be described (Questionnaire 3).	October 2019