Hereditary Spastic ParaparesisNCT04256681
SNAP: Measurement of the Subjective Perception of the Symptom in Hereditary Spastic Paraparesis (HSP)
A study testing SNAP questionnaire in people with Hereditary Spastic Paraparesis, run by IRCCS Eugenio Medea at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hereditary Spastic Paraparesis
- What is being tested?
- SNAP questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2018to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age less than 9 years
- IQ <80,
- loss of gait
- psychopathological aspects that can affect the validity of the data collected
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hereditary Spastic Paraparesis
- Being tested
- SNAP questionnaire
- Keywords
- OUTCOME MEASURE, HEREDITARY SPASTIC PARAPLEGIA
- Medical subject headings
- Spastic Paraplegia, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAP questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| patients affected by hereditary spastic paraplegia | Experimental | 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. Receives: Other: SNAP questionnaire |
| healthy subjects | Active comparator | 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. Receives: Other: SNAP questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Oct 2018
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Spastic ParaparesisStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256681
- Sponsor's protocol ID
- GIP 595
- Status last verified
- Nov 2021
- First submitted
- 3 Feb 2020
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38557877
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNAP: Measurement of the Subjective Perception of the Symptom in Hereditary Spastic Paraparesis (HSP)
- ClinicalTrials.gov ID
- NCT04256681
- Acronym / sponsor ID
- GIP 595
- Conditions
- Hereditary Spastic Paraparesis
- Keywords
- OUTCOME MEASURE, HEREDITARY SPASTIC PARAPLEGIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients affected by hereditary spastic paraplegia | Experimental | Other: SNAP questionnaire40 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 | Active comparator | Other: SNAP questionnaire40 healthy subjects will also be recruited to whom the questionnaire will be submitted to assess the variability of the score within a healthy population. |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Age less than 9 years
- IQ <80,
- loss of gait
- psychopathological aspects that can affect the validity of the data collected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNAP questionnaireThe 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. | Other | healthy subjects, patients affected by hereditary spastic paraplegia |
Primary outcome
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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
- Derived from this study: PubMed 38557877Diella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAP questionnaire in people with Hereditary Spastic Paraparesis, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04256681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.