Lee Silverman Voice Treatment Versus Standard Speech Therapy Versus Co
Lee Silverman Voice Treatment Versus Standard Speech and Language Therapy Versus Control in Multiple Sclerosis: a Randomized Controlled Trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Lee Silverman Voice Therapy
Compared with
- Conventional Treatment
What it measured
Main measures
Change in intensity (dB) of 3 sustained /ah/
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Change in intensity measured in decibel (dB) of three functional sentences
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Change in intensity in conversation measured in decibel (dB)
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Other measures (3)
Change in Maximum Phonation Time (MPT) of three sustained /ah/ (sec.)
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Change in Vocal Handicap Index
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Change in GIRBAS
at baseline, at 4 weeks (after the completion of 16 training sessions) and after 6-12 months up to the end of the rehabilitation program (FU)
Who could take part
MS (type not specified) · 18 to 90
Show the full criteria
Inclusion criteria
* Diagnosis of Multiple Sclerosis according with McDonald's criteria; * absence of relaps in the last month; * Mini Mental State Examination (MMSE) > 21 score for a better understanding and adherence to the execution of the proposed exercises; * hypophonia (conversation \< 60 dB SPL- distance was kept equal at about 15 cm); * ability to understand the aims of the study and acceptance to sign an informed consent; * acceptance of the intensity of the treatment; * ability to understand the Italian language.
Exclusion criteria
* Presence of other neurological disorders; * visual/hearing impairments hindering the rehabilitation program; * clinical history of laryngeal cancer, chemotherapy, radiotherapy, head and neck trauma or endotracheal intubation; * relapse or sudden changes in their MS symptoms within the previous 3 months.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The aim of the study is to identify the most effective method of intervention to reduce hypophonia in PwMS (Patient With Multiple Sclerosis), as a way to optimize the speech-therapy treatment based on scientific evidence. In the previous AB study, we aimed to verify the efficacy of LSVT LOUD® in PwSM: in the present study we will compare different treatment in a larger sample. Half of the participants will follow the LSVT Loud program, the other half will follow usual care rehabilitation programs. The results of these groups will be compared with an historical cohort of no treatment patients.
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History
Started
Jan 2018
Main results due
Sept 2019
Finished
Mar 2020