Effect of Massage Therapy in a Multisensory Environment for Intellectual Disabilities

NCT02120820 | Completed DMC

• 1 other identifier: HongKongPU
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Behavior Disturbance; Muscle Hypotonia

Keywords

massage; multisensory environment; challenging behaviours; relaxation

Outcome Measures

Primary Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (8)

• Alertness Observation Checklist (AOC)

  Baseline (At recruitment)

• Alertness Observation Checklist (AOC)

  5 weeks after intervention started (interim assessment)

• Alertness Observation Checklist (AOC)

  10 weeks after intervention started (Post-test 1)

• Alertness Observation Checklist (AOC)

  12 weeks after intervention started (Post-test 2)

• Behaviour Checklist (BC)

  Baseline (at recruitment)

Study Arms (4)

Multisensory environment

ACTIVE COMPARATOR

Multisensory environment (MSE): 30 minutes/session, twice a week for 10 weeks

Behavioral: Multisensory environment (MSE)

Massage therapy

ACTIVE COMPARATOR

Massage therapy (MT): 15 minutes/session, twice a week for 10 weeks

Behavioral: Massage therapy (MT)

Control group

OTHER

Control group: usual care for 10 weeks, with attention and interactions with the caregivers only.

Other: Control group

Massage in multisensory environment

ACTIVE COMPARATOR

Participants receive 15 minutes massage therapy in multisensory environment (MT-MSE), twice a week for 10 weeks.

Behavioral: Multisensory environment (MSE); Behavioral: Massage therapy (MT); Behavioral: Massage therapy in multisensory environment (MT-MSE)

Interventions

Multisensory environment (MSE) BEHAVIORAL

Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.

Also known as: Sensory stimulation, Snoezelen

Massage in multisensory environment; Multisensory environment

Massage therapy (MT) BEHAVIORAL

A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.

Also known as: Massage, Manual massage

Massage in multisensory environment; Massage therapy

Control group OTHER

Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.

Also known as: Placebo, no intervention

Control group

Massage therapy in multisensory environment (MT-MSE) BEHAVIORAL

Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.

Also known as: Massage, Sensory environment

Massage in multisensory environment

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Siu Lam Hospital

Tuenmen, New Territories, Hong Kong

Location

Related Publications (1)

• 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(6):532-548. doi: 10.1111/jir.12377. Epub 2017 Apr 7.

  PMID: 28387017 RESULT

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Massage; Manual Lymphatic Drainage; Control Groups

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Drainage; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Wai Tong CHIEN, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 23, 2014
• Study Start: April 15, 2013
• Primary Completion: June 30, 2017
• Study Completion: July 31, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)