Status:
RECRUITING
Sonification Techniques for Gait Training
Lead Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Conditions:
Parkinson Disease
Stroke
Eligibility:
All Genders
Up to 80 years
Phase:
NA
Brief Summary
Music therapy is widely used in relational and rehabilitation settings. In addition to Neurologic Music Therapy and other music-based techniques, "sonification" approaches were recently introduced in ...
Detailed Description
Background: Music therapy is widely used in relational settings. The sound can engage limbic and paralimbic areas and a variety of other brain areas strictly connected with movement (motor cortex, su...
Eligibility Criteria
Inclusion
- Inclusion criteria (stroke patients)
- Age \< 80
- Mini Mental State Examination \> 24
- Modified Rankin Scale: 1-3
- Single hemisphere lesion
- Stabilized disease (\> 6 months after the acute event)
- Impairment in gait parameters (e.g. velocity, perceived fatigue etc)
- Motor independence during walking (without orthotic devices and aids) but with pathological pattern (spasticity level: Ashworth \< 2)
- Inclusion criteria (patients with Parkinson's disease)
- Age \< 80
- Mini Mental State Examination \> 24
- Unified Parkinson Disease Rating Scale score (Parte III): \< 28
- Stabilized disease and drug therapy
- Altered gait patterns
- Motor independence during walking (without orthotic devices and aids) but with pathological pattern
- Inclusion criteria (patients with multiple sclerosis):
- Age \< 60
- Mini Mental State Examination \> 24
- Expanded Disability Status Scale score: 3-5
- Stabilized disease in the last 6 months (without relapse or disability progression)
- Altered gait patterns (i.e., careening, slowing down, spasticity: Ashworth \< 2, etc.)
- Motor independence during walking
- Exclusion Criteria (stroke patients)
- Multiple or bilateral lesions
- Neglect
- Equinism
- Spasticity: Ashworth \>2
- Structured (non-elastic) Achilles tendon retraction
- Neurotoxin in the 3 months prior to the study
- Baclofen introduced or modified in the week before the start of the study
- Previous or concurrent diseases disabling the lower limb functions
- Rehabilitative treatments with music in the year before the study
- Exclusion criteria (patients with Parkinson's disease):
- Previous or concurrent diseases disabling the lower limb functions
- Changes of drug therapy during the study
- Rehabilitative treatments with music in the year before the study
- Exclusion criteria (patients with multiple sclerosis):
- Previous or concurrent diseases disabling the lower limb functions
- Neurotoxin in the 3 months prior to the study
- Baclofen introduced or modified in the week before the start of the study
- Spasticity: Ashworth \>2
- Structured (non-elastic) Achilles tendon retraction
- Rehabilitative treatments with music in the year before the study
Exclusion
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04876339
Start Date
January 18 2021
End Date
June 30 2026
Last Update
May 11 2025
Active Locations (1)
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1
Istituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy, 27100