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

Completed

• Conditions: Post-stroke Spasticity

• Registration Number: NCT06381999
• Lead Sponsor: Merz Therapeutics GmbH

Brief 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.

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 Timeline

• Study Start: 2023-10-27
• Primary Completion: 2024-02-26
• Study Completion: 2024-02-26
• Status Verified: 2024-04
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-19
• Last Update Submitted: 2024-04-19
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Gailtal-Klinik; 🇦🇹 Hermagor, Austria