Muscle Hypotonia Clinical Trial
Official title:
An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities
The aim of this study is to evaluate the effectiveness of multisensory environment (MSE)
and/or massage therapy (MT) in residents with severe and profound intellectual disabilities
(ID) who received massage therapy in MSE, activities in MSE alone, massage therapy in usual
care environment, or usual care with attention.
Since there has not yet been any conclusive evidence to show the clinical efficacy of MT and
MSE on relaxation and reducing challenging behaviours, the following null hypotheses are
suggested:
1. There will not be any differences on reducing heart and respiration rates between
MT-MSE, MT, MSE, and usual care only over the 10-week intervention period and a 2-week
follow-up.
2. There will not be any differences on adaptive behaviours and levels of alertness between
MT-MSE, MT, MSE, and control group over the 10-week intervention period and a 2-week
follow-up.
3. There will not be any differences on frequency and severity of challenging behaviours
between MT-MSE, MT, MSE, and control group over the 10-week intervention period and a
2-week follow-up.
Design:
This study adopts a mixed methods research design, in which both quantitative (i.e.,
randomized controlled trial design) and qualitative (exploratory) approaches will be used.
Methods:
After the study criteria are checked and met and proxy consent has been obtained, the
participants will undergo a period of washout (4 weeks) from the current multisensory
environment (MSE) and/or massage therapy (MT) sessions. After that, the baseline measurement
of all outcome measures will be taken. All of them will then be randomly assigned to one of
the four study groups, including three treatment groups, namely massage therapy in MSE
(MT-MSE), MSE only and massage therapy in usual care environment (MT), and one control
(routine care) group.
The effects of the three proposed interventions and routine care only groups on the study
outcomes, including frequency and severity of challenging behaviour, adaptive behaviour,
alertness level, and heart and respiration rate, will be compared between groups at baseline,
interim (i.e., 5 weeks after the interventions started), immediately after completion of the
interventions (i.e. 10 weeks after the interventions started), and 2 weeks follow up (i.e. at
12 weeks from the start of intervention, but no intervention at week 11 and 12). A pilot
study will be conducted to review the feasibility and clarity of the study procedure,
intervention protocols, and outcome measurements in around 30 patients with similar clinical
characteristics (i.e., 8 subjects per groups) before starting the main study.
Primary outcomes of the study are frequency and severity of challenging behaviours, and the
physiological signs (i.e., respiration and pulse rate). The secondary outcomes are the levels
of alertness and adaptive behaviours.
Primary nurses who are responsible to formulate the individualized MSE and/or MT programs of
the participants in the three treatment groups will be invited to participate a face-to-face
semi-structured interview in order to explore their perceptions and opinions towards the
strengths and limitations of the intervention(s) used, factors influencing the challenging
behaviours of the disabled residents, and their suggested strategies in reducing their
clients' challenging behaviours in their work setting.
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