Robot-assisted Walking Treatment in Hereditary Spastic Paraplegia (HSP)

NCT ID: NCT06728787

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

In the field of rare neurological diseases, familiar spastic paraplegia represents a movement disorder with no specific therapy that can treat the disease or stop its evolution. Therefore, "therapy" is mainly symptomatic, going to act not on the cause of the disorder but on its clinical manifestation. In this context, the definition of effective rehabilitative treatment protocols is extremely important to ensure a qualitatively consistent intake with the goal of containing the functional decline related to the natural history of pathology. The crucial aspect of the disease is represented by alterations in gait pattern resulting in reduced functional skills and negative impact on the subject's quality of life.

Over the past 20 years, robotic technological gait rehabilitation has entered and spread in addition to conventional rehabilitation because of its ability to be highly motivating and engaging, showing itself effective as a complementary therapy. Among the various systems on the market, Lokomat (HOCOMA) is one of the most popular and widely used for treatment in both pediatric and adult populations. The literature is full with works in which Lokomat is used in subjects with neurological disorders (Stroke, Spinal Cord Injury, Infantile Cerebral Palsy) with good results especially in the functional domain. The objective of our study is to evaluate the efficacyof an intensive rehabilitation protocol with Lokomat combined with traditional treatment in a mixed population (pediatric and adult) of subjects with hereditary spastic paraplegia. In addition, follow-up evaluation will allow consideration of the maintenance of the results obtained from the intensive course.

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:

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).

The proposed study is both retrospective and prospective: 29 subjects have already been included in the retrospective database, and it is hypothesized to collect data from an additional 21 subjects.

The treatment will be able to take place in both inpatient and MAC settings, and the protocol includes performance evaluation through clinical and instrumental assessments in the population of subjects with HSP treated with the Lokomat device at the IRCCS Medea site in Bosisio Parini.

Conditions

Hereditary Spastic Paraplegia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Robot-Assisted Gait Training

Intervention Type: DEVICE

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.

Interventions

Robot-Assisted Gait Training

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Irccs Eugenio Medea

Bosisio Parini, Italy/lecco, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

ELEONORA DIELLA

Role: CONTACT

eleonora.diella@lanostrafamiglia.it

3286859456

Facility Contacts

ELEONORA DIELLA

Role: primary

eleonora.diella@lanostrafamiglia.it

3286859456

Other Identifiers

GIP 1065

Identifier Type: -

Identifier Source: org_study_id