Sonification Techniques for Gait Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 80
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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 the field of rehabilitation. The "sonification" can be defined as a properly selected set of sonorous-music stimuli are associated with patient movements mapping. In fact, the auditory-motor feedback can replace damaged proprioceptive circuits with a consequent improvement of the rehabilitation process. Interventions with "sonification" facilitate sensorimotor learning, proprioception and movements planning and execution improving global motor parameters. This study proposes the use of musical auditory cues which includes the melodic-harmonic component of the music. This kind of sonification makes the feedback pleasant and predictable as well as potentially effective. The investigators propose to apply and assess the effectiveness of this kind of sonification on gait training and other secondary outcomes in stroke, Parkinson's disease and multiple sclerosis population. Also, the investigators will assess the impact of "sonification" on the level of fatigue perceived during the rehabilitation process and on the quality of life. The study is a multicenter randomized controlled trial and will involve 120 patients that will undergo standard motor rehabilitation or the same rehabilitation but with the sonification support. The interventions will be evaluated at the baseline, after 10 sessions, after 20 sessions and at follow-up (one month after the end of the treatment). The assessment will include functional, motor, fatigue and quality of life evaluations. The collected data will be statistically processed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age < 80
Mini Mental State Examination > 24
Modified Rankin Scale: 1-3
Single hemisphere lesion
Disqualifiers
Multiple or bilateral lesions
Neglect
Equinism
Spasticity: Ashworth >2
Trial design
Design model
Parallel
Treatments tested in this trial
Gait rehabilitation with "sonification"
DeviceThe sonification system is composed by 2 inertial sensors, a computer and a pair of bluetooth headphones connected with the computer. The sensors will be placed one per leg at the ankle and connected with Matlab software. An home-made ad-hoc software associates patient's movements with music patterns. The patient's natural rhythm is detected and used at the beginning of the intervention. The first part of each exercise is supported by a pre-recorded chord progression with a click on the background. In the second part (sonification approach) the software notices and records the contact of the heel with the ground. Each contact activates musical stimuli listened to via headphones. The steps succession will build a regular and predictable musical progression in relation to the correct sequence of steps. The exercises planned in this intervention are the same as those planned in the gait standard rehabilitation (see below).
Standard gait rehabilitation (without sonification)
Other interventionThe training will be carried out without any musical support. Exercises I Phase 1. Load shift in anteroposterior standing in tandem position, left foot forward (3 minutes exercise with a short break in the middle) 2. Load shift in anteroposterior standing in tandem position, right foot forward (3 minutes exercise with a short break in the middle) 3. Left foot swing (3 minutes exercise with a short break in the middle) 4. Right foot swing (3 minutes exercise with a short break in the middle) 5. March in place (3 minutes exercise with a short break in the middle) Exercises II phase (15 minutes): the patient will perform 14 minutes of walking with a 1 minute of break in the middle (7 minutes of walking, 1 minute rest, 7 minutes of walking). In the second part of walking the patient will be asked to slightly increase the pace of the step up to the maximum possible speed.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Gait rehabilitation with "sonification"Experimental treatment 1 intervention
Group B: Standard gait rehabilitation (without sonification)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in the Six Minutes Walking Test
The gait speed will be evaluated (using the Six Minutes Walking Test) by comparing the variations of the test scores in the experimental and control group
Time frame
Change from Baseline Six Minutes Walking Test at 7 weeksSecondary outcomes
1
Mini BesTest
The balance will be evaluated (using the Mini BesTest) by comparing the variations of the test scores in the experimental and control group
Time frame
Up to 11 weeks2
Dynamic Gait Index
Dynamic balance and gait and risk of falls will be evaluated (using the Dynamic Gait Index) by comparing the variations of the test scores in the experimental and control group
Time frame
Up to 11 weeks3
Timed Up & Go
The mobility will be evaluated (using the Timed Up \& Go test) by comparing the variations of the test scores in the experimental and control group
Time frame
Up to 11 weeksOther outcomes
1
McGill Quality of Life- it
Quality of Life will be evaluated (using the McGill Quality of Life- it) by comparing the variations of the test scores in the experimental and control group
Time frame
Up to 11 weeks2
Global Perceived Effect
The overall effect of the intervention will be evaluated (using the Global Perceived Effect) by comparing the variations of the test scores in the experimental and control group
Time frame
Up to 11 weeks3
Visual Analogue Scale
The fatigue perceived will be evaluated (using a Visual Analogue Scale) by comparing the variations of the test scores in the experimental and control group
Time frame
Up to 11 weeksSponsors and contacts
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Source ClinicalTrials.gov