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.
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
- Recruiting
Irccs Eugenio Medea
Bosisio Parini, Italy/lecco
ELEONORA DIELLA, 3286859456, eleonora.diella@lanostrafamiglia.it
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.
- Conditions
- Hereditary Spastic Paraplegia
- 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 group | Role | What 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.
Six-Minute Walk Test (6MWT)
Endurance Test
Measured: T0(pre-training)
Six-Minute Walk Test (6MWT)
Endurance Test
Measured: T1(after 3 weeks of training)
Six-Minute Walk Test (6MWT)
Endurance Test
Measured: T2(3 months after T1)
Secondary outcomes (9)
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)
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)
Spastic Paraplegia Rating Scale (SPRS)
Severity of the HSP. Score: 0-52. Higher score more severity.
Measured: T0(pre-training)
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)
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)
Spastic Paraplegia Rating Scale (SPRS)
Severity of the HSP. Score: 0-52. Higher score more severity
Measured: T1(after 3 weeks of training)
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)
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)
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.
- First posted11 Dec 2024
- Study start1 Jan 2012
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Spastic ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Robot-assisted Walking Treatment on Gait Biomechanics, Functional Outcomes, and Quality of Life in Subjects With Hereditary Spastic Paraplegia (HSP)
- ClinicalTrials.gov ID
- NCT06728787
- Acronym / sponsor ID
- GIP 1065
- Conditions
- Hereditary Spastic Paraplegia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hereditary Spastic Paraplegia (HSP) | – | Device: Robot-Assisted Gait TrainingPatients 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. |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients affected by a hereditary spasti paraplegia with or without a genetic diagnosis.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted Gait Training15 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. | Device | Hereditary Spastic Paraplegia (HSP) |
Primary outcome
Six-Minute Walk Test (6MWT)
Time frame: T0(pre-training)
Endurance Test
Six-Minute Walk Test (6MWT)
Time frame: T1(after 3 weeks of training)
Endurance Test
Six-Minute Walk Test (6MWT)
Time frame: T2(3 months after T1)
Endurance Test
9 secondary outcomes
Medical Outcome Survey Short Form (SF-36)
Time frame: T0(pre-training)
Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)
Time frame: T0(pre-training)
Spastic Paraplegia Rating Scale (SPRS)
Time frame: T0(pre-training)
Medical Outcome Survey Short Form (SF-36)
Time frame: T1(after 3 weeks of training)
Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)
Time frame: T1(after 3 weeks of training)
Spastic Paraplegia Rating Scale (SPRS)
Time frame: T1(after 3 weeks of training)
Medical Outcome Survey Short Form (SF-36)
Time frame: T2(3 months after T1)
Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)
Time frame: T2(3 months after T1)
Spastic Paraplegia Rating Scale (SPRS)
Time frame: T2(3 months after T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.