Clinical Trial: Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Effects of Multisensory Stimulation and Enriched Environments During Post-traumatic Amnesia Following a Traumatic Brain Injury
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.
Detailed Summary:
Design: A phase II randomised controlled trial. Repeated measures of behaviour and sensory motor performance will be taken during PTA progression for all participants. The RCT involves two treatment arms and blinded assessment post-intervention at the point of PTA resolution, one month following PTA resolution, and a 6-month post-injury follow up questionnaire. The 2 treatment groups are:
- Experimental intervention protocol: occupation-based multisensory stimulation and the use of enriched environments;
- Control intervention protocol: standard therapy as provided by the hospital which includes re-orientation and participation in basic functional tasks.
Participants: Approximately twenty participants will be recruited from the Institut Guttmann, which is a neuro-rehabilitation hospital in Badalona, Spain.
Measures:
The evaluation tools will consist of standardised, established assessments used in brain injury rehabilitation which are detailed in the Outcome Measures section.
Procedure:
Repeated measurements of behaviour and sensory motor function corresponding to the participant's progression of PTA assessment scores will be taken. The maximum number of times a single participant will be tested during PTA is 7 times and twice again following emergence from PTA, within the first 3 days and again after 1 week. All measurements are non-invasive and provide minimal adverse risks for the participant.
Participants will be randomised into either the Experimental or Control group. Participants, their family members,
Sponsor: Institut Guttmann
Current Primary Outcome:
- Acceptability [ Time Frame: Through study completion, up to 6 months post-injury ]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.
- Demand [ Time Frame: Through study completion, up to 6 months post-injury ]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.
- Practicality [ Time Frame: Through study completion, up to 6 months post-injury ]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.
- Implementation [ Time Frame: Through study completion, up to 6 months post-injury ]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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cognitive function [ Time Frame: Through study completion, up to 6 months post-injury ]Measured using the Neurobehavioral Cognitive Status Examination (COGNISTAT) which is a cognitive screening assessment.
- Duration of PTA [ Time Frame: Through study completion, up to 6 months post-injury ]Measured using the Westmead PTA Scale (WPTAS). PTA duration is taken to be the number of days from the date of the initial injury until the participant achieves 12/12 on the Westmead PTA Scale.
- Visual perception performance [ Time Frame: Through study completion, up to 6 months post-injury ]Measured using the Developmental Test of Visual Perception - Adolescence and Adult version to measure visual perception and visual motor integration performance.
- Functional balance [ Time Frame: Through study completion, up to 6 months post-injury ]Measured using the Berg Balance Scale.
- Functional Independence [ Time Frame: Through study completion, up to 6 months post-injury ]Measured using the Functional Independence Measure (FIM).
- Level of agitation [ Time Frame: Through study completion, up to 6 months post-injury ]Measured using the Agitated Behavior Scale (ABS).
- Level of attention [ Time Frame: Through study completion, up to 6 months post-injury ]Measured using the Moss Attention Rating Scale (MARS).
Original Secondary Outcome: Same as current
Information By: Institut Guttmann
Dates:
Date Received: May 8, 2016
Date Started: August 2015
Date Completion: August 2017
Last Updated: June 2, 2016
Last Verified: June 2016
