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Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia

NCT02792985 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-06-08

No results posted yet for this study

Summary

The objective of this Phase II trial is to evaluate the feasibility of this study protocol to progress to a large-scale Phase III RCT in the future. It will also determine, with limited efficacy, the effectiveness of the multisensory stimulation intervention protocol to reduce the duration of post-traumatic amnesia (PTA), improve cognition, increase independence in activities of daily living and long term quality of life of the affected person.

Participants will be randomised into either the experimental or control group. The experimental group will follow the multisensory stimulation intervention protocol, while the control group will follow the current hospital protocol.

Conditions

  • Brain Injuries, Traumatic
  • Confusional State
  • Sensory Motor System Disorder
  • Alteration of Cognitive Function

Interventions

BEHAVIORAL

Multisensory stimulation protocol

Participation in occupation-based multisensory stimulation (e.g. personal care with aromatic soaps, varying water temperatures and textured sponges, drink preparation of different flavoured beverages) with a variety of different sensory stimuli (e.g. strong smells, different shapes and weights). The participant will receive two individual 30-minute therapy sessions with an Occupational Therapist. An enriched environment will be set up in the participant´s bedroom. It will include items that provide a range of meaningful sensory stimuli (e.g. familiar personal objects, projection of photos and known places, familiar music). The participant is encouraged to follow a timetable including regular rest breaks through out the day in their room.

BEHAVIORAL

Control protocol

Retraining of basic activities of daily living or participation in table top tasks and games in an individual 30 minute session or a one hour small group session with an Occupational Therapist. Minimal changes are made to the participant´s room (e.g. orientation board, photos of family and friends).

Sponsors & Collaborators

  • The University of Queensland

    collaborator OTHER

  • Institut Guttmann

    lead OTHER

Principal Investigators

  • Narda Murillo, PhD · Institut Guttmann

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-02-28
Completion
2017-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02792985 on ClinicalTrials.gov