Clinical Trial Summary
Stroke is one of the top causes of death and morbidity of adults, especially the older
population in the economically developed countries. People who survives from stroke attack
usually suffer from a wide range of impairments and often have poor chewing ability even when
they are physically well enough to be discharged from hospital. Aim of this proposed study is
to investigate the effects of providing masticatory muscles training exercises on the
masticatory performance, nutrition intake and general health conditions of stroke
rehabilitation patients. Around 100 stroke patients undergoing rehabilitation in the
rehabilitation centre in Tung Wah Eastern Hospital, Hong Kong, will be recruited and
allocated randomly into one of two study groups: Group 1 will be provided with an oral device
for chewing muscles exercises and training exercises on chewing (the intervention group); and
Group 2 will just follow the current stroke rehabilitation programme which does not have any
training in chewing (a negative control group). A video on the chewing muscles exercises will
be produced and placed online for the participants in Group 1 to view on demand. Data from
the participants in both groups will be collected at four time points: at baseline before
provision of the interventions, and at around 1, 3 and 6 months after the intervention. Each
participant will be interviewed by a trained interviewer and undergo a clinical examination.
The information collected will include the participant's oral health status such as numbers
of decayed teeth and occluding tooth pairs, and their masticatory performance measured both
objectively by chewing on a colour-changeable gum and subjectively by a chewing function
questionnaire. Their type of stroke (ischemic or hemorrhagic) and general health conditions
such as physical function status and nutrition intake will be recorded. The masticatory
performance and general health conditions of the two groups of study participants at baseline
and follow-up evaluations will be compared to assess if the masticatory muscles training
exercises can improve the rehabilitation outcomes. It is anticipated that this proposed
randomized trial will provide high-level clinical evidence to support the introduction of
masticatory muscles training exercises into the rehabilitation programme of stroke patients
and to inform how the exercises will benefit the patients, such as improving their chewing
ability and general health conditions.
