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Hereditary Spastic ParaplegiaNCT06728787

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

An observational study of Hereditary Spastic Paraplegia, run by IRCCS Eugenio Medea at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 70 years
Conditions the study is for
Hereditary Spastic Paraplegia
What is being tested?
Robot-Assisted Gait Training
Type of treatment
Medical device
How many people
50 participants
Where
1 siteItaly
Study dates
1 Jan 2012to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 4 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • Irccs Eugenio Medea

    Bosisio Parini, Italy/lecco

    ELEONORA DIELLA, 3286859456, eleonora.diella@lanostrafamiglia.it

    Recruiting

Other trials in Italy

About this study

Official title: Efficacy of Robot-assisted Walking Treatment on Gait Biomechanics, Functional Outcomes, and Quality of Life in Subjects With Hereditary Spastic Paraplegia (HSP)

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.

Read the 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.

Being tested
Robot-Assisted Gait Training
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.

  • 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.

Study groups in NCT06728787
Study groupRoleWhat they receive
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.
Receives: Device: Robot-Assisted Gait Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six-Minute Walk Test (6MWT)

    Endurance Test

    Measured: T0(pre-training)

  2. Six-Minute Walk Test (6MWT)

    Endurance Test

    Measured: T1(after 3 weeks of training)

  3. Six-Minute Walk Test (6MWT)

    Endurance Test

    Measured: T2(3 months after T1)

Secondary outcomes (9)
  1. Medical Outcome Survey Short Form (SF-36)

    Questionnaire Quality of Life. 2 index: physical health and mental health. Higher score better health perception.

    Measured: T0(pre-training)

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

    Questionnaire Self-Notion and Perception. Scoring: 0-48. Higher score better health.

    Measured: T0(pre-training)

  3. Spastic Paraplegia Rating Scale (SPRS)

    Severity of the HSP. Score: 0-52. Higher score more severity.

    Measured: T0(pre-training)

  4. Medical Outcome Survey Short Form (SF-36)

    Questionnaire Quality of Life. 2 index: physical health and mental health. Higher score better health perception.

    Measured: T1(after 3 weeks of training)

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

    Questionnaire Self-Notion and Perception. Scoring: 0-48. Higher score better health.

    Measured: T1(after 3 weeks of training)

  6. Spastic Paraplegia Rating Scale (SPRS)

    Severity of the HSP. Score: 0-52. Higher score more severity

    Measured: T1(after 3 weeks of training)

  7. Medical Outcome Survey Short Form (SF-36)

    Questionnaire Quality of Life. 2 index: physical health and mental health. Higher score better health perception.

    Measured: T2(3 months after T1)

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

    Questionnaire Self-Notion and Perception. Scoring: 0-48. Higher score better health.

    Measured: T2(3 months after T1)

  9. Spastic Paraplegia Rating Scale (SPRS)

    Severity of the HSP. Score: 0-52. Higher score more severity

    Measured: T2(3 months after T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start1 Jan 2012
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06728787
Sponsor's protocol ID
GIP 1065
Status last verified
Apr 2025
First submitted
17 Oct 2023
Last updated
4 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hereditary Spastic Paraplegia, 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 7 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ELEONORA DIELLA (3286859456, eleonora.diella@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six-Minute Walk Test (6MWT) (time frame: T0(pre-training)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 May 2025.

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