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

NCT ID: NCT06381999

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-27

Study Completion Date

2024-02-26

Brief Summary

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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

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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".

Conditions

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Post-stroke Spasticity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merz Therapeutics GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merz Medical Expert

Role: STUDY_DIRECTOR

Merz Therapeutics

Locations

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Gailtal-Klinik

Hermagor, , Austria

Site Status

Countries

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Austria

Other Identifiers

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M602011083

Identifier Type: -

Identifier Source: org_study_id

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