Effect of Treatment Dairy for Spasticity

NCT03384927 | Enrolling By Invitation

• 1 other identifier: RH-2017-292
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Assessing whether the treatment diary can help optimize the overall treatment of patients.
2. 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. 3.To assess whether the patient's quality of life is increased by the use of the treatment diary.

Conditions

Spasticity, Muscle

Keywords

Treatment diary

Outcome Measures

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).

  October 2019

Secondary Outcomes (2)

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

  October 2019

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

  October 2019

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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 during the study period, the participant will be withdrawn from the study.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Spasticity Clinic, Neurological Clinic, Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo BS Biering-Soerensen, Doctor

  Spasticity Clinic, Rigshospitalet Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Head of Clinic for spasticity

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 28, 2017
• Study Start: December 11, 2017
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

DK (1)