Effect of Treatment Dairy for Spasticity

NCT ID: NCT03384927

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-11

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Spasticity, Muscle

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Bo Biering-Soerensen

Doctor, Head of Clinic for spasticity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo BS Biering-Soerensen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Spasticity Clinic, Rigshospitalet Glostrup

Locations

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Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RH-2017-292

Identifier Type: -

Identifier Source: org_study_id

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