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

Not Applicable

Completed

• Conditions: Glycogen Storage Disease
• Interventions: Other: Lingual Muscle Training

• Registration Number: NCT03255213
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-03
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Study Start: 2018-03-21
• Primary Completion: 2020-04-23
• Study Completion: 2020-04-23
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Late Onset Pompe Disease who have tongue weakness	Lingual Muscle Training	-

Primary Outcome Measures

Name	Time	Method
Safety of lingual muscle training	13 weeks	Safety measured by pain rating scale
Feasibility of lingual muscle training as measured by questionnaires	13 weeks

Secondary Outcome Measures

Name	Time	Method
Change in lingual strength	baseline, 13 weeks	Change from pre-test to post-test

Trial Locations

Locations (1)

Duke University Medical Center and affiliated practices; 🇺🇸 Durham, North Carolina, United States