Initial Assessment of the Validity and Inter-Rater Reliability for Early Recognition of Spasticity Using the Decision Tree Tool
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post-stroke Spasticity
- Sponsor
- Merz Therapeutics GmbH
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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".
Investigators
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
Outcomes
Primary Outcomes
Assessment of the level of agreement between the nurse group and gold-standard group (trained, specialized physicians) in their decision for toxin treatment referral
Time Frame: 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 Outcomes
- 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)