Increase in mouth opening after exercise treatment using the following stretching devices: the TheraBite or Dynasplint.
ID
Bron
Aandoening
trismus
restricted mouth opening
mouth opening
head and neck cancer
head and neck neoplasms
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Effects of exercise therapy as change in mouth opening (millimetres)
Achtergrond van het onderzoek
Patients treated for head and neck cancer often suffer from several adverse effects after oncological treatment, including a severely restricted mouth opening (trismus). Trismus impacts oral functioning (biting, chewing, laughing, yawning, drinking, kissing etc.) considerably and as a result also quality of life. In this randomized controlled trial, two stretching devices, the TheraBite® Jaw Motion Rehabilitation System™ (TheraBite) and the Dynasplint Trismus System® (DTS), will be compared regarding the increase in mouth opening in head and neck cancer patients with a severely restricted mouth opening. Secondary outcome variables are oral functioning and quality of life.
Doel van het onderzoek
Increase in mouth opening after exercise treatment using the following stretching devices: the TheraBite or Dynasplint.
Onderzoeksopzet
week 0, 3, 6, 12, 26.
Onderzoeksproduct en/of interventie
DTS: 1 stretch per session, 3 times a day for 30 minutes. (a total of 90 minutes a day)
TheraBite: 20 stretches per session, 6 times a day, 30 seconds OR 30 stretches per session, 4 times a day, 30 seconds. (a total of 60 minutes a day
Publiek
P.U. Dijkstra
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
050 3613651
p.u.dijkstra@umcg.nl
Wetenschappelijk
P.U. Dijkstra
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
050 3613651
p.u.dijkstra@umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients (1) are at least 18 years, (2) received treatment concerning head and neck cancer (including surgery, radiotherapy and chemotherapy) (3) have a maximal mouth opening of 35 millimeter or less.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients diagnosed with osteoporosis or osteonecrosis or severe periodontitis, have oral abscesses or other infectious processes in the head and neck region, have a recurrence or metastases in the head and neck region.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4176 |
| NTR-old | NTR5589 |
| Ander register | 54802 : ABR |