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Exercise therapy to prevent Mandibular Hypomobilit in patients with Head and Neck Cancer undergoing Radiation Therapy

Exercise Therapy to prevent Radiation-induced Trismus in Head and Neck cancer Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-89mdvw
Enrollment
Unknown
Registered
2019-03-26
Start date
2014-05-20
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Trismus

Interventions

Total of 90 participants, 30 in each group. The patients will be allocated randomly across three groups: Exercise I (GI), Exercise II (GII) and control group (CG). The protocols used in each group wer
b) stretching: 6 sets of holding the TheraBite device at MMO for 30 seconds
c) strength training: 5 minutes of alternating bilateral chewing with a size XS Hiperboloide device. . GII: Same warmup and strength training protocol as in GI, but without the TheraBite stretching st
Other
E02.760.169.063.500.387.750
G11.427.410.698.277.968
E02.760.169.063.500.387.875
E06.276.125

Sponsors

Universidade Federal de Ciências da Saúde de Porto Alegre
Lead Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborator
Coordenção de Aperfeiçoamento de Pessoal de Pessoal de Nível Superior
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: either sex; age 18 years or more; formal histopathological diagnosis of oral or oropharynx cancer; undergoing radiotherapy alone or as adjunct to surgery or chemotherapy.

Exclusion criteria

Exclusion criteria: motor sequelae affecting the upper extremities, face or neck region, whether secondary to stroke, facial palsy; trigeminal neuralgia; trauma or surgery that precluded completion of the exercise protocols; cognitive impairments, such as Alzheimer’s disease; senile dementia; and Wernicke-Korsakoff syndrome; history of prior radiotherapy to the head and neck region; history of surgical interventions involving resection of the mandible; current physical therapy or speech pathology interventions for trismus; initial moth opening smaller than 10 mm.

Design outcomes

Primary

MeasureTime frame
Opening mouth range of motion, assessed by digital calliper, at the begining and at the ending of study.—

Secondary

MeasureTime frame
Oral mucositis will be graduated according to World Health Organization (WHO) Oral Toxicity Scale;Performance status will be measured by using the Karnofsky Performance Status (KPS);Pain intensity will be assessed using a visual analog scale (VAS);Assessment of quality of life will be through the University of Washington Quality of Life (UW-QOL) Questionnaire, version 4, which has been validated for the Brazilian population—

Countries

Brazil

Contacts

Public ContactKaroline Bragante

Universidade Federal de Ciências da Saúde de Porto Alegre

karoline.bragante@gmail.com+55-5133038700

Outcome results

None listed

Source: REBEC (via WHO ICTRP)