ClinicalTrials.gov record NCT06728787
Robot-assisted Walking Treatment in Hereditary Spastic Paraplegia (HSP)
Efficacy of Robot-assisted Walking Treatment on Gait Biomechanics, Functional Outcomes, and Quality of Life in Subjects With Hereditary Spastic Paraplegia (HSP)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study collects data on people with hereditary spastic paraplegia who underwent an intensive rehabilitation course combining Lokomat robot-assisted gait training with usual physical therapy (30 sessions over three weeks). Participants had clinical and instrumented assessments before treatment, at the end of the 3-week course, and at a 3-month follow-up. The study combines existing retrospective records (29 subjects) with planned prospective data (about 21 additional subjects). It is carried out as part of routine clinical practice.
What it is studying. The study evaluates how a combined intensive program of Lokomat robot-assisted gait training and conventional physical therapy is associated with changes in gait biomechanics, walking function, balance, severity scores, and quality of life in people with hereditary spastic paraplegia, and whether any changes are maintained at 3 months.
What the researchers hope to learn. To describe and quantify changes in gait biomechanics, walking endurance and speed, balance, clinical severity (SPRS), and quality of life (SF-36 and HSP-SNAP) after an intensive Lokomat plus physical therapy course, and to assess whether those changes persist at 3 months.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Robot-Assisted Gait Training
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
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.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants follow an intensive 3-week rehabilitation course of 30 sessions total: 15 robot-assisted gait (Lokomat) sessions plus 15 usual physical-therapy sessions, typically two sessions per day, five days a week, each about 45 minutes. Clinical and instrument assessments are done before treatment, at the end of the 3-week course, and again 3 months later; these include 3D gait analysis, walking tests (6MWT, 10MWT), functional scales (SPRS, GMFM-88, BBS) and quality-of-life questionnaires (SF-36, HSP-SNAP). No invasive procedures are listed in the record. The study uses both existing (retrospective) data and new (prospective) evaluations.
How the study is structured. Observational cohort study using both retrospective and prospective data. Includes people with HSP treated with a 3-week intensive course (15 Lokomat sessions + 15 physical therapy sessions). Clinical and instrumented assessments (including 3D gait analysis and standard walk, balance, severity, and quality-of-life measures) are collected at baseline, at the end of treatment (3 weeks), and at 3 months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on hereditary spastic paraplegia
Important dates
- Study start
- Jan 1, 2012
- Primary completion
- Dec 31, 2026 (estimated)
- Study completion
- Dec 31, 2026 (estimated)
- Target enrollment
- 50 participants (estimated)
- Last updated on registry
- May 4, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- IRCCS Eugenio Medea
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- ELEONORA DIELLA 📞 3286859456 ✉ eleonora.diella@lanostrafamiglia.it
Participating sites (1)
- Irccs Eugenio MedeaRecruiting
Bosisio Parini, Italy/lecco · Italy
- ELEONORA DIELLA · 3286859456 · eleonora.diella@lanostrafamiglia.it
Terms used on this page · explanations by MedicalUpdates.ai
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- Six-Minute Walk Test
- A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- natural history
- A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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