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

Post-stroke Spasticity Clinical Trial

— I-REFER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06381999
• Other study ID #: M602011083
• Status: Completed
• Start date: October 27, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: April 2024
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Post-stroke Spasticity

Locations

Country	Name	City	State
Austria	Gailtal-Klinik	Hermagor

Sponsors (1)

Lead Sponsor	Collaborator
Merz Therapeutics GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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