Spasticity, MuscleNCT03384927
Effect of Treatment Dairy for Spasticity
An observational study of Spasticity, Muscle, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spasticity, Muscle
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Dec 2017to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with muscle overactivity / spasticity independent of the cause and who are being followed as outpatients in the Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup.
Who may be able to join
- 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.
Who cannot join
- 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 during the study period, the participant will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup
Glostrup Municipality, 2600
About this study
Official title: Effect of Treatment Dairy on Botulinum Toxin Treatment for Muscle Overactivity (Spasticity). A Randomised Cross-over Study.
- Assessing whether the treatment diary can help optimize the overall treatment of patients.
- 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.
- To assess whether the patient's quality of life is increased by the use of the treatment diary.
Read the 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.
- Conditions
- Spasticity, Muscle
- Keywords
- Treatment diary
- Medical subject headings
- Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: October 2019
Secondary outcomes (2)
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)
Measured: October 2019
The patients' assessment of the treatment diary will be described (Questionnaire 3).
the patients' assessment of the treatment diary will be described (Questionnaire 3).
Measured: October 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start11 Dec 2017
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Biering-Soerensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo BS Biering-Soerensen, Doctor, Principal investigator, Spasticity Clinic, Rigshospitalet Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03384927
- Sponsor's protocol ID
- RH-2017-292
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2017
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment Dairy on Botulinum Toxin Treatment for Muscle Overactivity (Spasticity). A Randomised Cross-over Study.
- ClinicalTrials.gov ID
- NCT03384927
- Acronym / sponsor ID
- RH-2017-292
- Conditions
- Spasticity, Muscle
- Keywords
- Treatment diary
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Assessing whether the treatment diary can help optimize the overall treatment of patients.
- 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.
- 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with muscle overactivity / spasticity independent of the cause and who are being followed as outpatients in the Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo BS Biering-Soerensen, Doctor principal investigator
Spasticity Clinic, Rigshospitalet Glostrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, Muscle, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient becomes more satisfied with their treatment using the treatment diary (time frame: October 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.