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

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.

Study Overview

• Status: Completed
• Conditions: Post-stroke Spasticity

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 Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Austria
  • Hermagor, Austria, 9620
    • Gailtal-Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1-2

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Day 1-2

Collaborators and Investigators

• Sponsor: Merz Therapeutics GmbH
• Investigators: Study Director: Merz Medical Expert, Merz Therapeutics

Publications and helpful links

General Publications

• Fheodoroff K, Waeschle B, Schuetzer M, Comes G and Wissel J (2026) Early recognition of post-stroke spasticity: the I-REFER study. Front. Neurol. 17:1735793. doi: 10.3389/fneur.2026.1735793

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: M602011083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No