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

Hereditary Spastic Paraparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256681
• Other study ID #: GIP 595
• Status: Completed
• Phase: N/A
• Start date: October 30, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: November 2021
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hereditary Spastic Paraparesis
• Muscle Spasticity
• Paraparesis
• Paraparesis, Spastic

Intervention

Other:
• SNAP questionnaire
The SNAP questionnaire will be administered 2 times in 2 consecutive days to evaluate its reliability. The questionnaire will be self-filled by the patient. Then the SPRS scale and, where possible, the 6MWT will be administered.

Locations

Country	Name	City	State
Italy	Eleonora Diella	Bosisio Parini

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	2 days