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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06381999

Acronym

I-REFER

Enrollment

Registered

2024-04-24

Start date

2023-10-27

Completion date

2024-02-26

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Spasticity

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".

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Austria

Contacts

STUDY_DIRECTORMerz Medical Expert

Merz Therapeutics

Outcome results