Mastication training in adult patients with mitochondrial diseases: a pilot study.

Completed

Conditions: Mitochondrial disease
10027424
10021605

Registration Number: NL-OMON44341

Lead Sponsor: Radboudumc, afdeling Logopedie (kinderen), Afdeling Revalidatie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Genetically confirmed mitochondrial disease and aged >18.

Exclusion Criteria

- Not able to participate on the measurements at baseline, due to physical problems.
- Problems with oral intake, defined as a Functional Oral Intake Scale (FOIS), score 1 * 4 (see Appendix 1 in Protocol) (Crary, 2005)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1.Performance, using Mixing Ability Test: Mixing Index is derived.<br /><br>2.Efficacy, using Test of Mastication and Swallowing Solids (TOMASS): Z-scores<br /><br>are calculated (table1) for total bites, total masticatory cycles, total<br /><br>swallows and total time.<br /><br>3.Endurance, using the 6 Minutes Mastication Test (6MMT): Number of chewing<br /><br>cycles per minute and total number of chewing cycles are measured. The<br /><br>percentage difference between minute 1 and minute 6 is computed A numeric<br /><br>visual analogue scale (0-10) assess masticatory muscle pain and fatigue<br /><br>directly after the test and after 5 minutes.<br /><br>4. Bite force, using VU University Bite Force gauge (VU-BFG): Maximum bite<br /><br>force is measured taking the highest score in Newton. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are outcomes of the Mandibulaire functiebeperking<br /><br>vragenlijst (F1.1), and answers of the participants on the feasibility<br /><br>questionnaire (F1.2).</p><br>