Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
loudness |
Change in loudness over the period of the study which will be based on analysis of acoustic recordings. Loudness of voice will be measured in produce the vowel /a /, reading and spontaneous speech. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals. |
Change from Baseline in loudness at 4 weeks and 3 month follow up |
|
Secondary |
Voice Handicap Index (VHI) |
Change in Persian version of Voice Handicap Index (VHI) over the period of the study. The VHI measures the influence of voice problems on a patient's quality of life. The VHI is a 30 item scale. The total scores range is 0-120. A score 60-120 indicates severe voice problem. |
Change from Baseline in VHI at 4 weeks and 3 month follow up |
|
Secondary |
maximum phonation time (MPT) |
Change in maximum phonation time (MPT) over the period of the study. MPT will be measured by asking the subject to produce the long vowel /a/. This vocalization is measured three times, and the longest MPT is recorded. |
Change from Baseline in MPT at 4 weeks and 3 month follow up |
|
Secondary |
Speech Intelligibility |
Change in fudalla speech intelligibility rating scale over the period of the study. This scale consists of 7 rates in which the number 1 indicates Speech is not intelligible and number 7 indicates Speech is totally intelligible. |
Change from Baseline in Speech Intelligibility at 4 weeks and 3 month follow up |
|
Secondary |
Swallowing Disturbance Questionnaire (SDQ) |
Change in Persian version of Swallowing Disturbance Questionnaire (SDQ) over the period of the study. The SDQ is a 15 item scale. The total scores range is 0-45. A score higher 11 indicates swallowing difficulty. |
Change from Baseline in SDQ at 4 weeks and 3 month follow up |
|
Secondary |
Dysphagia handicap index (DHI) |
Change in Persian version of Dysphagia handicap index (DHI) over the period of the study. The DHI is one of the instruments used for measuring a dysphagic patient's self-assessment. it reflects the patient's quality of life. DHI is a 25 item scale. The total scores range is 0-100. A higher score indicates a greater impact of swallowing disorders on quality of life |
Change from Baseline in DHI at 4 weeks and 3 month follow up |
|
Secondary |
northwest dysphagia patient check sheet (NDPCS) |
Change in Persian version of northwest dysphagia patient check sheet (NPCS) scores over the period of the study. The NDPCS has five and 28 items. Each item is scored as safe or unsafe. The total score is calculated from the total number of unsafe items. The more unsafe observations indicates swallowing difficulty. |
Change from Baseline in NDPCS at 4 weeks and 3 month follow up |
|
Secondary |
Geriatric Depressive Scale (GDS) |
Change in Persian version of Geriatric Depressive Scale (GDS) scores over the period of the study. GDS is a 15 item scale. Each item is scored as yes or no. More than 5 signs indicate the possibility of depression and more than 10 signs of depression indicate definite depression. |
Change from Baseline in GDS at 4 weeks and 3 month follow up |
|
Secondary |
quality of life (QoL) |
Change in SF-36 questionnaire over the period of the study. Quality of life will be measured using SF-36 questionnaire. SF-36 is a 36 item scale. The total scores range is 0-100. A higher score indicates a better quality of life. |
Change from Baseline in QOL at 4 weeks and 3 month follow up |
|
Secondary |
jitter |
Change in jitter over the period of the study, which will be based on analysis of acoustic recordings. jitter will be measured in produce the vowel /a/. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals. |
Change from Baseline in jitter at 4 weeks and 3 month follow up |
|
Secondary |
shimmer |
Change in shimmer over the period of the study, which will be based on analysis of acoustic recordings. shimmer will be measured in produce the vowel /a/. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals. |
Change from Baseline in shimmer at 4 weeks and 3 month follow up |
|
Secondary |
highest and lowest frequency |
Change in highest and lowest frequency over the period of the study, which will be based on analysis of acoustic recordings. highest and lowest frequency will be measured by asking the subject to produce the vowel /a/ as high and low frequency as they can produces. Data will be analyzed using Praat, freeware program for the analysis and reconstruction of acoustic speech signals. |
Change from highest and lowest frequency at 4 weeks and 3 month follow up |
|