Robot-assisted Walking Treatment in Hereditary Spastic Paraplegia (HSP)
ConditionHereditary Spastic Paraplegia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-70
SponsorIRCCS Eugenio Medea
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients affected by a hereditary spasti paraplegia with or without a genetic diagnosis.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Robot-Assisted Gait Training
Device15 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Hereditary Spastic Paraplegia (HSP)1 intervention
Trial outcomes
Primary outcomes
1
Six-Minute Walk Test (6MWT)
Endurance Test
Time frame
T0(pre-training)2
Six-Minute Walk Test (6MWT)
Endurance Test
Time frame
T1(after 3 weeks of training)3
Six-Minute Walk Test (6MWT)
Endurance Test
Time frame
T2(3 months after T1)Secondary outcomes
1
Medical Outcome Survey Short Form (SF-36)
Questionnaire Quality of Life. 2 index: physical health and mental health. Higher score better health perception.
Time frame
T0(pre-training)2
Hereditary Spastic Paraplegia Self-Notion and Perception (HSP-SNAP)
Questionnaire Self-Notion and Perception. Scoring: 0-48. Higher score better health.
Time frame
T0(pre-training)3
Spastic Paraplegia Rating Scale (SPRS)
Severity of the HSP. Score: 0-52. Higher score more severity.
Time frame
T0(pre-training)4
Medical Outcome Survey Short Form (SF-36)
Questionnaire Quality of Life. 2 index: physical health and mental health. Higher score better health perception.
Time frame
T1(after 3 weeks of training)Other outcomes
1
3D GAIT ANALYSIS
Analysis of the gait pattern
Time frame
T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)2
Ten Meters Walk Test (10MWT)
Gait Velocity Test
Time frame
T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)3
Gross Motor Function Measure-88 (GMFM-88)
Pediatric Gross Motor Evaluation. Score:0-264. Higher score more function.
Time frame
T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)4
Berg Balance Scale (BBS)
Balance Test. Score:0-56. Higher score better balance.
Time frame
T0(pre-training),T1(after 3 weeks of training),T2(3 months after T1)Sponsors and contacts
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Source ClinicalTrials.gov