Muscle Hypotonia Clinical Trial
— MT-MSEOfficial title:
An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities
Verified date | August 2017 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 240 |
Est. completion date | July 31, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - exhibiting at least one type of challenging behavior - admitted at least 3 months for long-term care - being dependent on nursing care and physical assistance in daily activities - aged 18 to 64 years Exclusion Criteria: - seriously ill or completely bed-rest residents - having infectious diseases - frequently discharged to general hospital for acute care - frequent home or day leave - having pressure ulcer and/or severe contracture and deformity - being restless and reluctant to stay in multisensory environment, or receive massage therapy |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Siu Lam Hospital | Tuen Mun | New Territories |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
Chan JSL, Chien WT. A randomised controlled trial on evaluation of the clinical efficacy of massage therapy in a multisensory environment for residents with severe and profound intellectual disabilities: a pilot study. J Intellect Disabil Res. 2017 Jun;61 — View Citation
Chan JSL, Chien WT. A randomized controlled trial on clinical efficacy of massage therapy in a multisensory environment for residents with severe and profound intellectual disabilities. Neuropsychiatry (London) 7(4): 321-336, 2017. Doi: 10.4172/Neuropsych
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours | BPI-01 consists of 49 items with three subscales and has been widely employed in people with intellectual disability who are living in residential settings. This instrument is to evaluate the frequency and severity of challenging behaviours over the past two weeks of each assessment time points. Each item of the scale can be assessed on both frequency and severity of each kind of behaviour. The frequency scale is a 5-point rating scale: 0 - never, 1 - monthly, 2 - weekly, 3 - daily, and 4 - hourly. The severity scale is a 4-point Likert scale, denoted by: 0 - no problem, 1 - a slight problem, 2 - a moderate problem, and 3 - a severe problem. If a resident does not exhibit any behaviour listed in the item, "never" and "no problem" should be rated on that item. |
Baseline (at recruitment) | |
Primary | Behavior Problem Inventory (BPI-01) | Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 5. | 5 weeks after intervention started (interim assessment) | |
Primary | Behavior Problem Inventory (BPI-01) | Behavior Problem Inventory (BPI-01) (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 10. | 10 weeks after intervention started (Post-test 1) | |
Primary | Behavior Problem Inventory (BPI-01) | Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 12. | 12 weeks after intervention started (Post-test 2) | |
Primary | Respiration and Pulse Rate | Relaxation is a state of parasympathetic activation by vagal nerve, and suppressing the activity of sympathetic nervous system. If massage therapy and/or MSE indicate relaxation effect, the physiological parameters, i.e. pulse and respiration rates, are expected to drop to a lower level as compared with baseline readings after the interventions. Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions. Their average values will be used for outcome analysis. |
Baseline (at recruitment) | |
Primary | Respiration and Pulse Rate | Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 5. Their average values will be used for outcome analysis. | 5 weeks after intervention started (interim assessment) | |
Primary | Respiration and Pulse Rate | Respiration rate and heart (pulse) rate will be measured 3 minutes just after the participants attended the intervention sessions by the end of week 10. Their average values will be used for outcome analysis. | 10 weeks after intervention started (Post-test 1) | |
Primary | Respiration and Pulse Rate | Respiration rate and heart (pulse) rate will be measured 3 minutes by the end of week 12. Their average values will be used for outcome analysis. | 12 weeks after intervention started (Post-test 2) | |
Secondary | Alertness Observation Checklist (AOC) | With the Alertness Observation Checklist (AOC), four levels of alertness of the participants can be distinguished: active, inactive and withdrawn, sleeping or drowsy, and agitated and discontented. Each level will be assigned with a color for presentation, including green for active level, orange for inactive and withdrawn state, red for sleepy or drowsy state, and blue for an agitated and discontented state. Frequency of alertness levels will be observed during the interventions. The averaged frequency is used for outcome analysis. | Baseline (At recruitment) | |
Secondary | Alertness Observation Checklist (AOC) | Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 5. | 5 weeks after intervention started (interim assessment) | |
Secondary | Alertness Observation Checklist (AOC) | Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 10. | 10 weeks after intervention started (Post-test 1) | |
Secondary | Alertness Observation Checklist (AOC) | Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 12. | 12 weeks after intervention started (Post-test 2) | |
Secondary | Behaviour Checklist (BC) | The Behaviour Checklist (BC) was developed by Shapiro et al. (1997) to assess the behavioral reactions toward multi-sensory environment and relevant psychological interventions. It consists of 22 items in which 16 items are for self-stimulating behaviours and 6 items for adaptive behaviours. Frequency of each of the listed behaviors in the checklist will be observed and counted at 1-minute intervals during the intervention sessions. | Baseline (at recruitment) | |
Secondary | Behaviour Checklist (BC) | Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 5. | 5 weeks after intervention started (interim assessment) | |
Secondary | Behaviour Checklist (BC) | Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 10. | 10 weeks after intervention started (Post-test 1) | |
Secondary | Behaviour Checklist (BC) | Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 12. | 12 weeks after intervention started (Post-test 2) |
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