SNAP: Measurement of the Subjective Perception of the Symptom in Hereditary Spastic Paraparesis (HSP)

Not Applicable

Completed

• Conditions: Hereditary Spastic Paraparesis
• Interventions: Other: SNAP questionnaire

• Registration Number: NCT04256681
• Lead Sponsor: IRCCS Eugenio Medea

Brief Summary

The Self-Notion and Perception (SNAP) questionnaire developed at IRCCS E.Medea by Eleonora Diella and Roberta Morganti, arises from the need to quantify the subjective perception of the patient suffering from HSP of the typical symptoms of pathology, such as spasticity, weakness, changes in balance, resistance in walking, pain and fatigue. The purpose of this study is to validate this instrument and test its reliability, looking for correlations with the measurement scales used in the literature for the evaluation of the patient with HSP. The most used for this population are the Spastic Paraplegia Rating Scale (SPRS) and the Six-Minute Walk Test (6MWT) which assess the severity of the disease and the level of endurance (8-9) respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-30
• Study First Submitted: 2020-02-03
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-24
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• diagnosis of genetically determined hereditary spastic paraparesis or subjects without defined genetics but who unequivocally show at the time of evaluation a dominant or recessive familiarity with exclusive involvement of the pyramidal system
• age> 9 years
• IQ> 80
• The patient must be able to walk for at least 10 meters. Indoors, even with help

Exclusion Criteria

• Age less than 9 years
• IQ <80,
• loss of gait
• psychopathological aspects that can affect the validity of the data collected

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients affected by hereditary spastic paraplegia	SNAP questionnaire	40 subjects affected by genetically determined hereditary spastic paraparesis or subjects without defined genetics but who unequivocally show a dominant or recessive familiarity with exclusive involvement of the pyramidal system.
healthy subjects	SNAP questionnaire	40 healthy subjects will also be recruited to whom the questionnaire will be submitted to assess the variability of the score within a healthy population.

Primary Outcome Measures

Name	Time	Method
Test the validity, investigating the correlation with Spastic Paraplegia Rating Scale and with Six-Minute Walk Test, and the reliability (through test-retest mode) of the SNAP questionnaire in the aforementioned population.	2 days	the Spastic Paraplegia Rating Scale (SPRS) and the Six-Minute Walk Test (6MWT) which assess the severity of the disease and the level of endurance respectively.

Trial Locations

Locations (1)

Eleonora Diella; 🇮🇹 Bosisio Parini, Italy