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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44341

Enrollment

Registered

2018-02-06

Start date

2018-02-12

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitochondrial disease

Interventions

The intervention will consist of an 8 weeks low intensity mastication training using sugar free chewing gum. The instructions for training are 1 piece of sugar free chewing gum per exercise, 3 exerc

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Genetically confirmed mitochondrial disease and aged >18.

Exclusion criteria

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)

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary parameters are outcomes of the Mandibulaire functiebeperking vragenlijst (F1.1), and answers of the participants on the feasibility questionnaire (F1.2).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)