Post-stroke SpasticityI-REFERNCT06381999
Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool
An observational study of Post-stroke Spasticity, run by Merz Therapeutics GmbH at 1 site in Austria.
Trial summary
The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-stroke Spasticity
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 27 Oct 2023to 26 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants are post-stroke survivors and patients of the Gailtal Clinic in Hermagor. Participants were either sub-acute in-patients as part of the post-stroke rehabilitation program or chronic out-patients. Participants are recruited using consecutive participant sampling. All sub-acute patients in the rehabilitation ward who fulfill inclusion criteria and agree to participate are enrolled. Additionally, chronic patients scheduled for botulinum toxin injections on the study day are also enrolled in the study.
Who may be able to join
- Participants with a first sub-acute and chronic infarction of the middle cerebral artery / basal ganglia hemorrhage longer than four weeks after the event
- Between 18-80 years old
- Preserved insight and judgment capacity
- Adequate language and task comprehension, attention span for 15 minutes
Who cannot join
- Participants with other neurological disorders
- Participants who received BoNT-A treatment < 3 months before inclusion
- Reduced vigilance and attention span (less than 15 minutes)
- Participants with adult representation
- Participants with severe language impairment / impairment of movement and action sequences
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Assessment of the Validity and Inter-Rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool
The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool.
Read the detailed description
The Spastic Movement Disorder (SMD) Decision Tree was designed as a tool to aid nurses, therapists and other healthcare professions recognize potential signs of disabling spasticity in the upper limb of post-stroke patients. The present study assesses validity and inter-rater reliability of the SMD Decision Tree comparing nurses and therapists with gold-standard procedure performed by rehabilitation doctors. Agreement was tested for "referral to specialist indicated" and "no referral to specialist indicated".
- Conditions
- Post-stroke Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral
Nurses use the 3 domains of the SMD Decision Tree (passive/active movement, pain) to determine potential disabling spasticity indicated for referral to a rehabilitation specialist. Specialized physicians use standard clinical procedure to detect disabling spasticity.
Measured: Day 1-2
Secondary outcomes (1)
Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral
Measured: Day 1-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start27 Oct 2023
- Primary completion26 Feb 2024
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke SpasticityStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Therapeutics GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Merz Medical Expert, Study director, Merz Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381999
- Sponsor's protocol ID
- M602011083
- Acronym
- I-REFER
- Status last verified
- May 2026
- First submitted
- 19 Apr 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fheodoroff K, Waeschle B, Schuetzer M, Comes G, Wissel J. Early recognition of post-stroke spasticity: the I-REFER study. Front Neurol. 2026 May 13;17:1735793. doi: 10.3389/fneur.2026.1735793. eCollection 2026.
PubMed 42211298
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Assessment of the Validity and Inter-Rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool
- ClinicalTrials.gov ID
- NCT06381999
- Acronym / sponsor ID
- I-REFER / M602011083
- Conditions
- Post-stroke Spasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Merz Therapeutics GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 24 Apr 2024 (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.
The aim of this study is to investigate the validity and Inter-rater reliability for early recognition of spasticity by nurses and physiotherapists using the decision tree tool.
Detailed description
The Spastic Movement Disorder (SMD) Decision Tree was designed as a tool to aid nurses, therapists and other healthcare professions recognize potential signs of disabling spasticity in the upper limb of post-stroke patients. The present study assesses validity and inter-rater reliability of the SMD Decision Tree comparing nurses and therapists with gold-standard procedure performed by rehabilitation doctors. Agreement was tested for "referral to specialist indicated" and "no referral to specialist indicated".
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants are post-stroke survivors and patients of the Gailtal Clinic in Hermagor. Participants were either sub-acute in-patients as part of the post-stroke rehabilitation program or chronic out-patients. Participants are recruited using consecutive participant sampling. All sub-acute patients in the rehabilitation ward who fulfill inclusion criteria and agree to participate are enrolled. Additionally, chronic patients scheduled for botulinum toxin injections on the study day are also enrolled in the study.
Key inclusion criteria (4 listed)
- Participants with a first sub-acute and chronic infarction of the middle cerebral artery / basal ganglia hemorrhage longer than four weeks after the event
- Between 18-80 years old
- Preserved insight and judgment capacity
- Adequate language and task comprehension, attention span for 15 minutes
Key exclusion criteria (5 listed)
- Participants with other neurological disorders
- Participants who received BoNT-A treatment < 3 months before inclusion
- Reduced vigilance and attention span (less than 15 minutes)
- Participants with adult representation
- Participants with severe language impairment / impairment of movement and action sequences
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
Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral
Time frame: Day 1-2
Nurses use the 3 domains of the SMD Decision Tree (passive/active movement, pain) to determine potential disabling spasticity indicated for referral to a rehabilitation specialist. Specialized physicians use standard clinical procedure to detect disabling spasticity.
1 secondary outcome
Assessment of the level of agreement between the physiotherapist and/or occupational therapist group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral
Time frame: Day 1-2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Results publication: PubMed 42211298Fheodoroff K, Waeschle B, Schuetzer M, Comes G, Wissel J. Early recognition of post-stroke spasticity: the I-REFER study. Front Neurol. 2026 May 13;17:1735793. doi: 10.3389/fneur.2026.1735793. eCollection 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Merz Medical Expert study director
Merz Therapeutics
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 Post-stroke Spasticity, run by Merz Therapeutics GmbH at 1 site in Austria.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 22 May 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral (time frame: Day 1-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06381999, which also lists 1 linked publication.
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 May 2026.