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CompletedNCT06381999I-REFERUpdated May 22, 2026

Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool

An observational study in Post-stroke Spasticity, sponsored by Merz Therapeutics GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Merz Therapeutics GmbH · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
70
Ages
18 Years to 80 Years
Sex
All
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Study 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 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".

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Conditions studied

  • Post-stroke Spasticity
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In context

Lead sponsor

Merz Therapeutics GmbH is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
70 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: Day 1-2

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Study locations

1 site
  • Gailtal-Klinik
    Hermagor, 9620, Austria
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06381999
Lead sponsor
Merz Therapeutics GmbH
Responsible party
Sponsor
First posted
Apr 24, 2024
Start date
Oct 27, 2023
Primary completion
Feb 26, 2024
Completion
Feb 26, 2024
Last update
May 22, 2026

Study contacts

Merz Medical Expert
study director · Merz Therapeutics

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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