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)

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.

Study Overview

• Status: Recruiting
• Conditions: Hereditary Spastic Paraplegia
• Intervention / Treatment: Device: Robot-Assisted Gait Training

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: ELEONORA DIELLA; Phone Number: 3286859456; Email: eleonora.diella@lanostrafamiglia.it

Study Locations

• Italy
  • Italy/lecco
    • Bosisio Parini, Italy/lecco, Italy
      • Recruiting
      • IRCCS Eugenio Medea
      • Contact: ELEONORA DIELLA; Phone Number: 3286859456; Email: eleonora.diella@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-Minute Walk Test (6MWT)	Endurance Test	T0(pre-training)
Six-Minute Walk Test (6MWT)	Endurance Test	T1(after 3 weeks of training)
Six-Minute Walk Test (6MWT)	Endurance Test	T2(3 months after T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Outcome Survey Short Form (SF-36)	Questionnaire Quality of Life. 2 index: physical health and mental health. Higher score better health perception.	T0(pre-training)
Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)	Questionnaire Self-Notion and Perception. Scoring: 0-48. Higher score better health.	T0(pre-training)
Spastic Paraplegia Rating Scale (SPRS)	Severity of the HSP. Score: 0-52. Higher score more severity.	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.	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.	T1(after 3 weeks of training)
Spastic Paraplegia Rating Scale (SPRS)	Severity of the HSP. Score: 0-52. Higher score more severity	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.	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.	T2(3 months after T1)
Spastic Paraplegia Rating Scale (SPRS)	Severity of the HSP. Score: 0-52. Higher score more severity	T2(3 months after T1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D GAIT ANALYSIS	Analysis of the gait pattern	T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
Ten Meters Walk Test (10MWT)	Gait Velocity Test	T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
3D GAIT ANALYSIS	Analysis of the gait pattern	T1(after 3 weeks of training)
Ten Meters Walk Test (10MWT)	Gait Velocity Test	T1(after 3 weeks of training)
3D GAIT ANALYSIS	Analysis of the gait pattern	T2(3 months after T1)
Ten Meters Walk Test (10MWT)	Gait Velocity Test	T2(3 months after T1)
Gross Motor Function Measure-88 (GMFM-88)	Pediatric Gross Motor Evaluation. Score:0-264. Higher score more function.	T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
Berg Balance Scale (BBS)	Balance Test. Score:0-56. Higher score better balance.	T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)
Gross Motor Function Measure-88 (GMFM-88)	Pediatric Gross Motor Evaluation. Score:0-264. Higher score more function.	T1(after 3 weeks of training)
Berg Balance Scale (BBS)	Balance Test. Score:0-56. Higher score better balance.	T1(after 3 weeks of training)
Gross Motor Function Measure-88 (GMFM-88)	Pediatric Gross Motor Evaluation. Score:0-264. Higher score more function.	T2(3 months after T1)
Berg Balance Scale (BBS)	Balance Test. Score:0-56. Higher score better balance.	T2(3 months after T1)

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neuromuscular Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neurodegenerative Diseases; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Nervous System Malformations; Polyneuropathies; Paralysis; Hereditary Sensory and Motor Neuropathy; Muscle Spasticity; Paraplegia; Spastic Paraplegia, Hereditary
• Other Study ID Numbers: GIP 1065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No