Clinical trial NCT06381999: Validity and Inter-rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool
Official title: Initial Assessment of the Validity and Inter-Rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-stroke Spasticity
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2024-04-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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".

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral
timeFrame: Day 1-2
Secondary outcomes:
measure: 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
timeFrame: Day 1-2
Other outcomes:
Locations:
city: Hermagor
country: Austria
facility: Gailtal-Klinik
Study officials:
affiliation: Merz Therapeutics
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: