NCT06728787

Brief Summary

Patients will undergo a combined rehabilitation treatment consisting of 15 sessions on Lokomat and 15 sessions of physical therapy over three weeks for a total of 30 sessions. Two sessions/day for 5 days a week. The same subjects will conduct clinical-functional assessments before, at the end of treatment, and after a 3-month follow-up: 3D Gait Analysis with defined protocol (BTSBioenginner); Spastic Paraplegia Rating Scale (SPRS); Six-Minute Walk Test (6MWT), Ten Meters Walk Test (10MWT), Gross Motor Function Measure-88 (GMFM-88) and Berg Balance Scale (BBS); Quality of life questionnaires: Medical Outcome Survey Short Form (SF-36) and ad hoc questionnaire for subjective assessment of symptoms during walking (HSP-SNAP). This study is part of normal clinical practice and does not involve any changes to the current rehabilitation course for patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress96%
Jan 2012Dec 2026

Study Start

First participant enrolled

January 1, 2012

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

15 years

First QC Date

October 17, 2023

Last Update Submit

April 30, 2025

Conditions

Hereditary Spastic Paraplegia

Outcome Measures

Primary Outcomes (3)

  • Six-Minute Walk Test (6MWT)

    Endurance Test

    T0(pre-training)

  • Six-Minute Walk Test (6MWT)

    Endurance Test

    T1(after 3 weeks of training)

  • Six-Minute Walk Test (6MWT)

    Endurance Test

    T2(3 months after T1)

Secondary Outcomes (9)

  • Medical Outcome Survey Short Form (SF-36)

    T0(pre-training)

  • Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)

    T0(pre-training)

  • Spastic Paraplegia Rating Scale (SPRS)

    T0(pre-training)

  • Medical Outcome Survey Short Form (SF-36)

    T1(after 3 weeks of training)

  • Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)

    T1(after 3 weeks of training)

  • +4 more secondary outcomes

Other Outcomes (12)

  • 3D GAIT ANALYSIS

    T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)

  • Ten Meters Walk Test (10MWT)

    T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)

  • Gross Motor Function Measure-88 (GMFM-88)

    T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)

  • +9 more other outcomes

Study Arms (1)

Hereditary Spastic Paraplegia (HSP)

Patients undergo a combined rehabilitation treatment consisting of 15 sessions on Lokomat and 15 sessions of physical therapy over three weeks for a total of 30 sessions. The same subjects undergo clinical-functional evaluations before, at the end of treatment and after a 3-month follow-up.

Device: Robot-Assisted Gait Training

Interventions

Robot-Assisted Gait TrainingDEVICE

15 sessions of robot-assisted gait training(LOKOMAT)+ 15 session of usual treatment for a total of 30 sessions in three weeks. 45 minutes for each session.

Hereditary Spastic Paraplegia (HSP)

Eligibility Criteria

Age4 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients affected by a hereditary spasti paraplegia with or without a genetic diagnosis.

You may qualify if:

  • genetic or clinical diagnosis of HSP.
  • age greater than 4 years and less than 70
  • femur length \> 23 cm
  • ability to walk independently indoors, with or without walking aids.

You may not qualify if:

  • botulinum toxin injection or lower limb surgery in the previous 6 months
  • severe lower limb muscle retractions
  • severe osteoporosis
  • unhealed skin lesions in lower limbs
  • cardiovascular instability
  • acute or progressive neurological disorders
  • behavioral problemS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Irccs Eugenio Medea

Bosisio Parini, Italy/lecco, Italy

RECRUITING

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

Central Study Contacts

ELEONORA DIELLA

CONTACT

3286859456eleonora.diella@lanostrafamiglia.it

Study Design

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

Study Record Dates

First Submitted

October 17, 2023

First Posted

December 11, 2024

Study Start

January 1, 2012

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)