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

NCT ID: NCT04256681

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2021-05-31

Brief Summary

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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

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Conditions

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Hereditary Spastic Paraparesis

Keywords

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OUTCOME MEASURE, HEREDITARY SPASTIC PARAPLEGIA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patients affected by hereditary spastic paraplegia

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.

Group Type EXPERIMENTAL

SNAP questionnaire

Intervention Type OTHER

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.

healthy subjects

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.

Group Type ACTIVE_COMPARATOR

SNAP questionnaire

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eleonora Diella

Bosisio Parini, , Italy

Site Status

Countries

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Italy

References

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Diella E, D'Angelo MG, Stefan C, Girardi G, Morganti R, Martinuzzi A, Biffi E. Validation of the Italian version of a patient-reported outcome measure for Hereditary Spastic Paraplegia. PLoS One. 2024 Apr 1;19(4):e0301452. doi: 10.1371/journal.pone.0301452. eCollection 2024.

Reference Type DERIVED
PMID: 38557877 (View on PubMed)

Other Identifiers

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GIP 595

Identifier Type: -

Identifier Source: org_study_id