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NCT Number: NCT06381999

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.

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Key information

Conditions

Post-Stroke Spasticity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gailtal-Klinik

Hermagor, 9620, Austria

About this study

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".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    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.

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

Sponsors and collaborators

Lead sponsor

Merz Therapeutics GmbH

Industry

Registry information

Official study title

Initial Assessment of the Validity and Inter-Rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool

Acronym: I-REFER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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