NCT05373082

Brief Summary

A first questionnaire - MODIFSPA conducted in 2014 - identified several environmental factors influencing spasticity in HSP: cold, fatigue, and especially physical activity. In order to improve the care of patients with HSP, The investigator team are looking to deepen the knowledge on physical exercises relieving spasticity as well as to better know the frequency of symptoms requiring additional medical care: fatigue and vesico-sphincter disorders. A new questionnaire was therefore created to collect additional information to optimize the care of patients with HSP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

March 4, 2022

Last Update Submit

October 27, 2023

Conditions

Hereditary Spastic Paraplegia

Outcome Measures

Primary Outcomes (1)

  • factors influencing spasticity

    Temperature,stress, anxiety , intercurrent infection, physical activities and tiredness are the factors influencing spasticity (common symptom of all these patients): Only questions are asked with yes and no answers

    1 day

Secondary Outcomes (3)

  • Physical activities

    1 day

  • Symptoms

    1 day

  • Anxiety

    1 day

Study Arms (1)

Patients with hereditary spastic Paraplegia

Patients with hereditary spastic Paraplegia

Other: questionnaire completion

Interventions

questionnaire completionOTHER

Questionnaire to be completed by patients

Patients with hereditary spastic Paraplegia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Hereditary Spastic Paraplegia (HSP)

You may qualify if:

  • French-speaking adult patients aware of their PSH diagnosis coming to the genetic consultation at the Pitié-Salpêtrière Hospital or informed via an association / website of the BRAINTEAM study network
  • Affiliated with social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Cerveau, ICM

Paris, 75013, France

Location

MeSH Terms

Conditions

Spastic Paraplegia, Hereditary

Condition Hierarchy (Ancestors)

Hereditary Sensory and Motor NeuropathyNervous System MalformationsNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

May 13, 2022

Study Start

October 4, 2022

Primary Completion

October 3, 2023

Study Completion

October 3, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Locations

FR(1)