Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia

NCT02792985 | Unknown

• 1 other identifier: 2014.205
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Acceptability

  The number of participants who consent to participate compared to the number who withdraw. Further understanding of this area of feasibility will be generated by family reports of satisfaction with participation in the study and reflection of the observations recorded in the project coordinator´s daily log book.

  Through study completion, up to 6 months post-injury

• Demand

  The percentage of eligible patients who give consent to participate in the study and the percentage that dropout after starting the study. To provide further insight of this feasibility area, analysis of demographic information of those who consent, decline or dropout will be done.

  Through study completion, up to 6 months post-injury

• Practicality

  Brief cost analysis to identify and measure the resources required to implement the study. A record will be taken in the project coordinator´s log book of factors observed to affect efficiency, speed, quality of implementation, or any adverse events that may occur.

  Through study completion, up to 6 months post-injury

• Implementation

  To measure this area of feasibility, the adherence to respective protocols for each participant will be taken including the number of days and amount of time participants attend therapy sessions. Moreover, assessment of the appropriateness of the secondary outcome measures and feasibility of the assessment protocol will be conducted.

  Through study completion, up to 6 months post-injury

Secondary Outcomes (7)

• Cognitive function

  Through study completion, up to 6 months post-injury

• Duration of PTA

  Through study completion, up to 6 months post-injury

• Visual perception performance

  Through study completion, up to 6 months post-injury

• Functional balance

  Through study completion, up to 6 months post-injury

• Functional Independence

  Through study completion, up to 6 months post-injury

Study Arms (2)

Multisensory stimulation protocol

EXPERIMENTAL

The Experimental group will follow an intervention protocol.

Behavioral: Multisensory stimulation protocol

Control protocol

ACTIVE COMPARATOR

The Control group will follow the current protocol for patients in PTA at the Institut Guttmann.

Behavioral: Control protocol

Interventions

Multisensory stimulation protocol BEHAVIORAL

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.

Multisensory stimulation protocol

Control protocol BEHAVIORAL

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).

Control protocol

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of TBI
• within 6 months of their initial brain injury
• in PTA (Levels of Cognitive Function 4-6)
• appropriate visual and auditory function to observe the environment and hear instructions with or without assistive aids
• independent use of one upper limb

You may not qualify if:

• a previous brain injury
• illness, diseases or alcohol or drug addiction that could affect cognitive function
• having a learning disability prior to injury
• participant is out of PTA
• visual, auditory, aphasic or motor disturbance that may interfere with the ability to complete the task or participate in the sessions

Sponsors & Collaborators

• Institut Guttmann: lead
• The University of Queensland: collaborator

Study Sites (1)

Institut Guttmann

Badalona, Barcelona, 08916, Spain

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Confusion

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Narda Murillo, PhD

  Institut Guttmann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayley Walsh

CONTACT

+34934977700; hayley.walsh@uqconnect.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: June 8, 2016
• Study Start: August 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 8, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)