An interventional study of Multisensory stimulation protocol and Control protocol in Brain Injuries, Traumatic, Confusional State and Sensory Motor System Disorder, sponsored by Institut Guttmann. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-08.
Sponsored by Institut Guttmann · Not applicable, Interventional, and Treatment
Among 24 studies in Brain Injuries, Traumatic with a site in Spain — 4 open to participants now, 5 under way, 2 of them phase 3. Brain Injuries, Traumatic · Spain.
Among the 24 studies in Brain Injuries, Traumatic with a site in Spain, this one is the 18th largest by planned enrollment of the 20 interventional ones, is one of 2 that started in 2015, is one of 9 with no phase, and was the 9th registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 20 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →4 of the 24 studies in Brain Injuries, Traumatic with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →24 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2015.
Median enrollment 42 across the 20 interventional studies, 1,000 across the 4 observational. Of the 15 that completed or were terminated, 5 (33%) have results posted.
7 of 24 have an industry lead sponsor. The 10 most frequent:
Institut Guttmann is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Institut Guttmann has 3 studies filed under Brain Injuries, Traumatic — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 24 studies in Brain Injuries, Traumatic with a site in Spain, from their registry updates:
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.
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:
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, and the assessor taking outcome measures at the point of PTA resolution and one-month post-resolution will be blinded to group allocation and subsequent intervention protocol. Intervention provision will occur throughout the progression of PTA with post-intervention assessment to occur within 3 days of the end of PTA, one month after coming out of PTA, and through a follow-up questionnaire to be completed by the participant and family members at 6 months post-injury. All interventions are non-invasive and do not involve any risks above those that may be incurred through participation in the standard rehabilitation process.
The Experimental group will follow an intervention protocol involving transformation of the participant´s room into a sensory stimulating enriched environment (EE) and participation in occupation-based multisensory stimulation (OBMS) during their therapy sessions with an occupational therapist. They will receive two daily 30-minute individual therapy sessions.
The control group will follow the current protocol for patients in PTA at the Institut Guttmann. This includes one 30-minute individual therapy session or one hour group therapy session with an occupational therapist and minimal changes to their room (e.g. orientation board, photos of family and friends).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The Experimental group will follow an intervention protocol.
Behavioral: Multisensory stimulation protocol
The Control group will follow the current protocol for patients in PTA at the Institut Guttmann.
Behavioral: Control 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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, up to 6 months post-injury
Cognitive function
Measured using the Neurobehavioral Cognitive Status Examination (COGNISTAT) which is a cognitive screening assessment.
Time frame: Through study completion, up to 6 months post-injury
Duration of PTA
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.
Time frame: Through study completion, up to 6 months post-injury
Visual perception performance
Measured using the Developmental Test of Visual Perception - Adolescence and Adult version to measure visual perception and visual motor integration performance.
Time frame: Through study completion, up to 6 months post-injury
Functional balance
Measured using the Berg Balance Scale.
Time frame: Through study completion, up to 6 months post-injury
Functional Independence
Measured using the Functional Independence Measure (FIM).
Time frame: Through study completion, up to 6 months post-injury
Level of agitation
Measured using the Agitated Behavior Scale (ABS).
Time frame: Through study completion, up to 6 months post-injury
Level of attention
Measured using the Moss Attention Rating Scale (MARS).
Time frame: Through study completion, up to 6 months post-injury
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Aug 2015, a primary completion of Feb 2017 and a completion of Aug 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Institut Guttmann