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

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Merz Pharmaceuticals

Status

Completed

Conditions

Post-stroke Spasticity

Study type

Observational

Funder types

Industry

Identifiers

NCT06381999
M602011083

Details and patient eligibility

About

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.

Full 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".

Enrollment

73 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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