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

NCT06381999 | Completed

• 1 other identifier: M602011083
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Spasticity

Outcome Measures

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.

  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

  Day 1-2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Male, Female, and Diverse were eligible.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Participants with other neurological disorders
• Reduced vigilance and attention span (less than 15 minutes)
• Participants with adult representation
• Participants with severe language impairment / impairment of movement and action sequences

Sponsors & Collaborators

• Merz Therapeutics GmbH: lead

Study Sites (1)

Gailtal-Klinik

Hermagor, 9620, Austria

Location

Study Officials

• Merz Medical Expert

  Merz Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: October 27, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)