Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
Expiratory Muscle Strength Training (EMST-150)
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Jessica E Huber, Ph.D., Purdue University
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Purdue University
West Lafayette, Indiana, 47906 United States
Full Study Summary:
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 Sponsor:
Purdue University
Participant Duration:
~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training)
Estimated Enrollment:
30
Estimated Study Start Date:
01 / 01 / 2021
Estimated Study Completion Date:
08 / 01 / 2022
Posting Last Modified Date:
06 / 03 / 2022
Date Study Added to neals.org:
08 / 12 / 2021
Minimum Age:
40 Years
Maximum Age:
70 Years
Can participants use Riluzole?
Yes
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)
Purdue University
West Lafayette, Indiana
47906
United States