Clinical Trial: Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: An Evaluation of the Clinical Efficacy of Massage Therapy in a Multisensory Environment for Residents With Severe and Profound Intellectual Disabilities

Brief Summary:

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.

Detailed Summary:

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
Sponsor: The Hong Kong Polytechnic University

Current Primary Outcome:

  • Behavior Problem Inventory (BPI-01): frequency and severity of challenging behaviours [ Time Frame: Baseline (at recruitment) ]

    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.

  • Behavior Problem Inventory (BPI-01) [ Time Frame: 5 weeks after intervention started (interim assessment) ]
    Behavior Problem Inventory (as described above) will be used to measure the frequency and severity of challenging behaviours by the end of week 5.
  • Behavior Problem Inventory (BPI-01) [ Time Frame: 10 weeks after intervention started (Post-test 1) ]
    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.
  • Behavior Problem Inventory (BPI-01) [ Time Frame: 12 weeks after in

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Alertness Observation Checklist (AOC) [ Time Frame: Baseline (At recruitment) ]
      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.
    • Alertness Observation Checklist (AOC) [ Time Frame: 5 weeks after intervention started (interim assessment) ]
      Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 5.
    • Alertness Observation Checklist (AOC) [ Time Frame: 10 weeks after intervention started (Post-test 1) ]
      Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 10.
    • Alertness Observation Checklist (AOC) [ Time Frame: 12 weeks after intervention started (Post-test 2) ]
      Alertness Observation Checklist (AOC) will be used to measure the average amount of the four levels of alertness by the end of week 12.
    • Behaviour Checklist (BC) [ Time Frame: Baseline (at recruitment) ]
      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.
    • Behaviour Checklist (BC) [ Time Frame: 5 weeks after intervention started (interim assessment) ]
      Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 5.
    • Behaviour Checklist (BC) [ Time Frame: 10 weeks after intervention started (Post-test 1) ]
      Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 10.
    • Behaviour Checklist (BC) [ Time Frame: 12 weeks after intervention started (Post-test 2) ]
      Behaviour Checklist (BC) will be used to measure the frequency of self-stimulating and adaptive behaviours by the end of week 12.


    Original Secondary Outcome: Same as current

    Information By: The Hong Kong Polytechnic University

    Dates:
    Date Received: April 16, 2014
    Date Started: April 15, 2013
    Date Completion: July 31, 2017
    Last Updated: February 22, 2017
    Last Verified: February 2017