Lingual Muscle Training in Late-Onset Pompe Disease (LOPD) (NCT03255213) | Clinical Trial Compass
CompletedNot Applicable
Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)
United States5 participantsStarted 2018-03-21
Plain-language summary
This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help design future research studies about LMT in LOPD.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Age ≥ 12 years
* Lingual weakness as measured by quantitative muscle testing (≤ 5% lower limit of normal for stratified age)
* Confirmed diagnosis of LOPD
* On enzyme replacement therapy for ≥ 26 weeks at pretest
* Able to follow directions for study participation
* Able to complete a home-based LMT regimen
* Access to reliable internet connection
* Access to use of electronic device that allows for FaceTime, Jabber, or WebEx use
Exclusion Criteria:
* Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
* Any current or past history of seizures.
* Head and neck cancer or radiation treatment to head/neck
* Inability to tolerate IOPI device tongue bulb
* Inability to give legally effective consent
* Inability to read and understand English
What they're measuring
1
Safety of lingual muscle training
Timeframe: 13 weeks
2
Feasibility of lingual muscle training as measured by questionnaires