Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Purdue University
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Change From Baseline to Post-treatment for Maximum Expiratory Pressure
Study Overview
Brief Summary
A tele-health treatment study for individuals with early stage ALS with the aim to improve communication, cough response, and respiratory strength. All participants complete a respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150) device from the comfort of their homes for 6 weeks.
Detailed Description
The investigators are looking for people with early stage ALS to participate in a completely tele-health (no in-person visits required) treatment study examining the effects of an Expiratory Muscle Strength Training device (EMST-150) on communication, cough, and respiratory strength. Participants will be required to attend 2 virtual baseline assessment sessions followed by 12 additional virtual training sessions (2 per week for 6 weeks). Participants should plan to be actively enrolled in the study for ~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training). Participants will also be required to fill out a series of questionnaires assessing the EMST's effectiveness via tele-health.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of ALS
- •Within the early stages of disease progression (i.e., able to talk, breathe, and eat independently)
- •Speaker of English
- •Have a family member/caregiver willing to assist as needed
- •Have access to an electronic device and internet for tele-health
Exclusion Criteria
- •A history of neurological disease (besides ALS)
- •A history of asthma or respiratory problems (e.g., COPD, emphysema)
- •A history of head, neck, or chest surgery (except mastectomy)
- •A history of smoking within the last 5 years
- •Reliance on mechanical ventilation (including CPAP)
Outcomes
Primary Outcomes
Change From Baseline to Post-treatment for Maximum Expiratory Pressure
Time Frame: Baseline 2 (week 2), Pre-Training (week 3), and Post-Training (week 10)
Change in expiratory muscle strength throughout the study duration measured by the participant blowing into a pressure meter
Secondary Outcomes
- Change From Baseline to Post-Treatment in Number of Pauses(Baseline 1 (week 1) and Post-Training (week 10))
- Adherence to Training Protocol(Measured each week of training across the entire training duration)
- Change From Baseline to Post-Treatment in Syntactic Location of Pauses(Baseline 1 (week 1) and Post-Training (week 10))
- Change From Baseline to Post-Treatment in ALS Quality of Life Scale(Baseline 1 (week 1) and Post-Training (week 10))
- ALS Function Rating Scale Revised(Baseline 1 (week 1) and Post-Training (week 10))
- Psychosocial Impact of Assistive Devices Scale(Post-treatment (week 10))
- Peak Expiratory Flow Rate(Baseline 2 (week 2), Pre-training (week 3), Post-Training (week 10))
- Change From Baseline to Post-Treatment in Utterance Length(Baseline 1 (week 1) and Post-Training (week 10))
- Telehealth Satisfaction(Post-Training (week 10))
- Change From Pre-Training to Post-Training in Communication Participation Item Bank(Pre-Training (week 3) and Post-Training (week 10))
- Tele-health Session Attendance(Measured at the end of training across the entire training period)
Investigators
HuberLab
Professor, SLHS
Purdue University