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Enrolling by invitationNCT03384927Updated Oct 22, 2026

Effect of Treatment Dairy for Spasticity

An observational study in Spasticity, Muscle, sponsored by Copenhagen University Hospital, Rigshospitalet. Enrolling by invitation at 1 site in Denmark. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Copenhagen University Hospital, Rigshospitalet · Observational

Updated Oct 22, 2026Primary completion movedStudy completion moved+3 moreGo to Updates ↓
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
96
Sex
All
01

Study 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.
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.

02

Conditions studied

  • Spasticity, Muscle

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Keywords

  • Treatment diary
03

In context

Muscle Spasticity

621 studies on the registry are indexed under Muscle Spasticity; 127 are open to participants now.

This study's planned enrollment of 96 is above the median of 60 across 137 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Copenhagen University Hospital, Rigshospitalet is the lead sponsor of 42 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
96 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: October 2019

Secondary outcomes

  1. 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)

    Time frame: October 2019

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

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

    Time frame: October 2019

07

Study locations

1 site
  • Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup
    Glostrup Municipality, 2600, Denmark
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Dec 2026, 108 months after the start.

Of 54 non-industry observational studies under Muscle Spasticity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9. This study's planned 108 months is above that.

Counting every sponsor, half of 59 studies reached it within 32 months; a quarter within 9 and three quarters within 124.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Dec 2025 → Dec 2026 and completion Dec 2025 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Dec 28, 2017
StartActual
Dec 11, 2017
Primary completionEst.
Dec 30, 2026was Dec 2025
CompletionEst.
Dec 30, 2026was Dec 2025
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup · Glostrup Municipality, Denmark
Show 1 removed
  • Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup · Glostrup, Denmark
Oct 22, 2026
Primary completion
Dec 30, 2025→Dec 30, 2026
Oct 22, 2026
Study completion
Dec 30, 2025→Dec 30, 2026
Oct 22, 2026
Sponsor
Rigshospitalet, Denmark→Copenhagen University Hospital, Rigshospitalet
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    1 site added, 1 site removed
    Show site
    • Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup · Glostrup Municipality, Denmark
    Show 1 removed
    • Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup · Glostrup, Denmark
    Primary completion Dec 30, 2025→Dec 30, 2026
    Study completion Dec 30, 2025→Dec 30, 2026
    Sponsor Rigshospitalet, Denmark→Copenhagen University Hospital, Rigshospitalet
    + 4 other changes: identifiers, verification date, oversight details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT03384927
Lead sponsor
Copenhagen University Hospital, Rigshospitalet
Responsible party
Bo Biering-Soerensen (Doctor, Head of Clinic for spasticity, Copenhagen University Hospital, Rigshospitalet) — Principal investigator
First posted
Dec 28, 2017
Start date
Dec 11, 2017
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Oct 22, 2026

Study contacts

Bo BS Biering-Soerensen, Doctor
principal investigator · Spasticity Clinic, Rigshospitalet Glostrup

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Copenhagen University Hospital, Rigshospitalet

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