Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Change in expiratory muscle strength throughout the study duration measured by the participant blowing into a pressure meter

Time frame: Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)

Population: All participants with baseline, pre-training, and post-treatment maximum expiratory pressure values were included. The second baseline and pre-training values were averaged to obtain the pre-training value which was used along with the week 10 value (post-treatment).

Number of of training exhalations completed (25 exhalations into the device, 5 days per week) by participants throughout the study duration

Time frame: Measured each week of training across the entire training duration

A survey that quantifies change in disease progression throughout the study duration. Participants rate how 12 physical functions are impacted by their ALS. For each function, participants are provided with a 4-point Likert scale to rate whether they still have complete control of that function (4) or no ability to perform that function (0). Total scores range from 0 to 48, with lower scores indicating more severe symptoms and higher scores and less severe symptoms.

Time frame: Baseline 1 (week 1) and Post-Training (week 10)

Population: All participants with baseline (week 1) and post-training (week 10) scores were included.

The ALS Quality of Life Scale-Revised (ALSQOL-R) (Simmons, 2015) was used to measure how ALS impacts their quality of life in six domains: negative emotion, interaction with people and the environment, intimacy, religiosity, physical symptoms, and bulbar function. Participants rate whether they strongly disagree (0) or strongly agree (10) with 46 statements. Each domain score is given an average value between 0 (worse) and 10 (best). Total scores on the ALSQOL-R range from 0-460, but an average score ranging from 0-10 is computed by dividing the total score by the total number of items completed by the participant (usually 46). Higher scores reflect a higher quality of life. A survey assessing how each participant feels ALS impacts quality of life, and how that changes throughout the study duration. Total scores range from 0-460, with higher scores indicating greater contributions of ALS to quality of life.

Time frame: Baseline 1 (week 1) and Post-Training (week 10)

Population: All participants with pre- and post-training scores on the scale. Lower scores reflect less effect of ALS on quality of life.

Change in the total number of pauses that included breathing (breath pauses). Participant read the Rainbow Passage and data were collected from this task.

Time frame: Baseline 1 (week 1) and Post-Training (week 10)

Population: All participants with baseline and post-training values. Data from the first baseline and the week 10 post-treatment value were used.

Change in the location of pauses while breathing produced while reading. We determined where participants took breaths while reading the Rainbow Passage and categorized them according to syntax. Categories included at a major boundary (at the end of an independent clause marked by a period) and at a boundary that is not related to syntax (not a major or minor syntactical location). The number of pauses at each category of boundaries were converted to a percent of the total breaths taken while reading the passage.

Time frame: Baseline 1 (week 1) and Post-Training (week 10)

Population: All participants with baseline and post-training values. Data from baseline (week 1) and post-training (week 10) were used.

Change in utterance length (# of syllables produced on one breath) throughout the study duration. Participant read the Rainbow Passage and data were collected from this task.

Time frame: Baseline 1 (week 1) and Post-Training (week 10)

Population: All participants who had baseline and post-training values for this measure. Data from the first baseline and the week 10 post-treatment value were used.

Participants were instructed to use a 4-point Likert scale (3: not at all; 2: a little; 1: quite a bit; 0: very much) to rate if/how their ALS impacts ten hypothetical communicative situations. Participants total scores were then added together, ranging from 0-30, and converted to a T-score ranging from 24.2-71.0. High scores are more favorable, indicating that the participant feels that ALS impacts their communicative participation less than those with lower scores.

Time frame: Pre-Training (week 3) and Post-Training (week 10)

Population: All participants with pre- and post-training scores. Data from the pre-training in week 3 and the week 10 post-treatment value were used.

Change in cough strength (as measured by peak expiratory flow rate) throughout the study duration, measured using a flow meter that the participant coughs into - single coughs. Data from baseline 2 and pre-training were averaged for the pre--training value.

Time frame: Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10)

Population: All participants with baseline 2 (week 2) and pre-training values (week 3) and post-training (week 10) data were included.

A survey assessing how the training device/modality impacts patient's psychosocial functions. The PIADS includes 12 items for competence, 6 for adaptability, and 8 for self-esteem. Participants use a 7-point Likert scale to rate the impact of a device on each item: a maximum negative impact (-3), somewhat negative impact (-2 or -1), zero impact (0), somewhat positive impact (1 or 2), maximum positive impact (3). Total scores range from -78 (maximum negative impact) to 78 (maximum positive impact).

Time frame: Post-treatment (week 10)

Population: All participants with a post-treatment (week 10) score.

Participants rated 15 statements with a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). Example statements include: I can easily talk to my health-care provider, I can hear my health-care provider clearly, I can see my health-care provider as if we met in person, I think the care provided via telemedicine is consistent, and I receive adequate attention, telemedicine provides for my health care need, and overall, I am satisfied with the quality of service being provided via telemedicine. Total scores range from 0-75 and individual statement scores ranged from 1-5, with higher scores indicating higher satisfaction with the telepractice modality.

Time frame: Post-Training (week 10)

Population: Only assessed at post-training. Included all participants who completed the scale. Higher values reflect more satisfaction and the score maximum is 75.

% of training sessions scheduled and attended by participants throughout the study duration

Time frame: Measured at the end of training across the entire training period

Population: Participants who completed the training protocol