Clinical trial NCT06728787: Robot-assisted Walking Treatment in Hereditary Spastic Paraplegia (HSP)
Official title: Efficacy of Robot-assisted Walking Treatment on Gait Biomechanics, Functional Outcomes, and Quality of Life in Subjects With Hereditary Spastic Paraplegia (HSP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hereditary Spastic Paraplegia
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected by a hereditary spasti paraplegia with or without a genetic diagnosis.

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.

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

Primary outcomes:
measure: Six-Minute Walk Test (6MWT)
timeFrame: T0(pre-training)
measure: Six-Minute Walk Test (6MWT)
timeFrame: T1(after 3 weeks of training)
measure: Six-Minute Walk Test (6MWT)
timeFrame: T2(3 months after T1)
Secondary outcomes:
measure: Medical Outcome Survey Short Form (SF-36)
timeFrame: T0(pre-training)
measure: Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)
timeFrame: T0(pre-training)
measure: Spastic Paraplegia Rating Scale (SPRS)
timeFrame: T0(pre-training)
measure: Medical Outcome Survey Short Form (SF-36)
timeFrame: T1(after 3 weeks of training)
measure: Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)
timeFrame: T1(after 3 weeks of training)
measure: Spastic Paraplegia Rating Scale (SPRS)
timeFrame: T1(after 3 weeks of training)
measure: Medical Outcome Survey Short Form (SF-36)
timeFrame: T2(3 months after T1)
measure: Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)
timeFrame: T2(3 months after T1)
measure: Spastic Paraplegia Rating Scale (SPRS)
timeFrame: T2(3 months after T1)
Other outcomes:
measure: 3D GAIT ANALYSIS
timeFrame: T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
measure: Ten Meters Walk Test (10MWT)
timeFrame: T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
measure: Berg Balance Scale (BBS)
timeFrame: T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
measure: 3D GAIT ANALYSIS
timeFrame: T1(after 3 weeks of training)
measure: Ten Meters Walk Test (10MWT)
timeFrame: T1(after 3 weeks of training)
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: T1(after 3 weeks of training)
measure: Berg Balance Scale (BBS)
timeFrame: T1(after 3 weeks of training)
measure: 3D GAIT ANALYSIS
timeFrame: T2(3 months after T1)
measure: Ten Meters Walk Test (10MWT)
timeFrame: T2(3 months after T1)
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: T2(3 months after T1)
measure: Berg Balance Scale (BBS)
timeFrame: T2(3 months after T1)
Locations:
city: Bosisio Parini
country: Italy
facility: Irccs Eugenio Medea
state: Italy/lecco
Study officials:
References: