N/A N=13 Treatment

Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Amyotrophic Lateral Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT05003167 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: Change From Baseline to Post-treatment for Maximum Expiratory Pressure — 66.10; 83.75 cmH2O — p=.001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Expiratory Muscle Strength Training (EMST-150) (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Purdue University
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Post-treatment for Maximum Expiratory Pressure	66.10; 83.75	.001 sig
SECONDARY Peak Expiratory Flow Rate	265.97; 273.47	—
SECONDARY Change From Baseline to Post-Treatment in Utterance Length	10.76; 10.39	.113
SECONDARY Change From Baseline to Post-Treatment in Number of Pauses	15.89; 16.75	.052
SECONDARY Change From Baseline to Post-Treatment in Syntactic Location of Pauses	47.12; 46.09; 8.71; 12.33	.931
SECONDARY Telehealth Satisfaction	60.58	—
SECONDARY Change From Pre-Training to Post-Training in Communication Participation Item Bank	47.78; 48.51	—
SECONDARY Change From Baseline to Post-Treatment in ALS Quality of Life Scale	5.97; 5.94	—
SECONDARY ALS Function Rating Scale Revised	39; 37	—
SECONDARY Psychosocial Impact of Assistive Devices Scale	28.08	—
SECONDARY Tele-health Session Attendance	95.37	—
SECONDARY Adherence to Training Protocol	90.65	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05003167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.