Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2020-04-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Glycogen Storage Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Late Onset Pompe Disease who have tongue weakness

Group Type EXPERIMENTAL

Lingual Muscle Training

Intervention Type OTHER

Lingual Muscle Training using the Iowa Oral Performance Instrument (OIPI) device

Interventions

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Lingual Muscle Training

Lingual Muscle Training using the Iowa Oral Performance Instrument (OIPI) device

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No