RecruitingNCT06728787

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)


Sponsor

IRCCS Eugenio Medea

Enrollment

50 participants

Start Date

Jan 1, 2012

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

DEVICERobot-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.


Locations(1)

Irccs Eugenio Medea

Bosisio Parini, Italy/lecco, Italy

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NCT06728787


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