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

Primary Purpose

Hereditary Spastic Paraparesis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

SNAP questionnaire

About this trial

This is an interventional other trial for Hereditary Spastic Paraparesis focused on measuring OUTCOME MEASURE, HEREDITARY SPASTIC PARAPLEGIA

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Eleonora Diella

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients affected by hereditary spastic paraplegia

healthy subjects

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04256681

First Posted

February 3, 2020

Last Updated

November 24, 2021

Sponsor

IRCCS Eugenio Medea

1. Study Identification

Unique Protocol Identification Number

NCT04256681

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

October 30, 2018 (Actual)

Primary Completion Date

May 31, 2021 (Actual)

Study Completion Date

May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IRCCS Eugenio Medea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hereditary Spastic Paraparesis

Keywords

OUTCOME MEASURE, HEREDITARY SPASTIC PARAPLEGIA

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

patients affected by hereditary spastic paraplegia

Arm Type

Experimental

Arm Description

Arm Title

healthy subjects

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

SNAP questionnaire

Intervention Description

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.

Primary Outcome Measure Information:

Title

Description

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.

Time Frame

2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

9 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Eleonora Diella

City

Bosisio Parini

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

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