Traumatic Brain Injury
Conditions
Keywords
motor-cognitive training, dual-task, TBI
Brief summary
The goal of this clinical study is to test feasibility of a motor-cognitive training program in patients after mild to severe traumatic brain injury in an acute hospitalization setting. The intervention is a step-based dual-task training, i.e. patients are presented with step patterns that they have to memorize and then execute in the tempo given by a metronome. Researchers will assess the feasibility of the motor-cognitive training regarding acceptance and safety, user evaluation of the training and training performance.
Detailed description
A traumatic brain injury (TBI) refers to a functional disorder of the brain with or without demonstrable injuries to the brain as a result of external force to the skull and/or brain. The most common causes are traffic accidents and falls. After TBI, impairments may occur in motor skills such as gait stability, static and dynamic balance and motor coordination as well as cognitive skills such as memory, dual- and multi-tasking (DT/MT), and psychomotor speed. Therefore, rapid improvement of motor and cognitive functioning and falls prevention are essential. Dual-task training have been shown to improve gait performance and to reduce the risk of falling in some neurological disorders, such as Parkinson's disease and stroke. Although there are differences in the underlying pathophysiology between these neurological conditions and TBI, research has identified many common fall-risk factors and thus it can be expected that TBI patients would also profit from cognitive-motor dual-task training. However, research on the effects of such training in TBI patients in scarce. To our knowledge, there is only one study that has looked into the effects of dual-task motor-cognitive training in people with neurological conditions, including (but not specifically for) persons with TBI. For this reason, this study aims to assess the feasibility of a concept for stepping training (StepIt) that addresses motor as well as cognitive falls-related aspects in patients with TBI. This study will be conducted as one-arm, monocentric intervention trial. After admission to the normal ward, patients potentially fulfilling the eligibility criteria will be informed orally and in writing about the study and asked if they wish to participate. All interested participants will then be screened for final inclusion. Baseline data collection will occur prior to the first training session and training evaluation will be conducted after 3 to max. 10 trainings (depending on the length of their hospital stay). During each training session individual training parameters will be documented. In addition to the usual care, the study participants receive the motor-cognitive training StepIt. The StepIt will be conducted as an approximately 15-minute one on one training for at least 3 to max. 10 sessions during the stay at the hospital.
Interventions
The motor-cognitive training in this study will be conducted in form of a step-based dual-task training. A mat (approximately 90 x 90 cm) made from extra non-slip yoga mats is required. The mat is divided into 9 equal squares with a 3 x 3 pattern. Participants will be presented with stepping patterns which they must memorize and then execute on the mat in the pace given by a metronome. All participants will start at the same level. The progression will be adjusted individually according to the fixed criteria of the StepIt concept within the sessions. All sessions will be supervised by at least one physical therapist.
Sponsors
Cantonal Hospital of St. Gallen
Swiss Federal Institute of Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* People diagnosed with mild (Glasgow Coma Scale 14-15), moderate (Glasgow Coma Scale 9-13) or severe (Glasgow Coma Scale 3-8) TBI * Age ≥ 18 years * Planned hospital treatment \>24h on regular ward (non-ICU) * Physically able to stand (using cane if needed) * Able to give informed consent
Exclusion criteria
* Limited vision and hearing ability (except facial injuries with monocular swelling) * Inability or contraindications to undergo the investigated intervention. * ICU stay only * Montreal Cognitive Assessment (MoCa) score \< 16
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Security incidents | through study completion, an average of 9 months (over all training sessions) | Total number of (Serious) Adverse Events (SAE/AE) |
| Inclusion rate | through study completion, an average of 9 months | Number of patients included in the study as percentages of patients fitting to the inclusion (resp. exclusion) criteria |
| Attrition rate | through study completion, an average of 9 months | Number of Drop-outs as percentages of patients included in the study |
| Adherence rate | through study completion, an average of 9 months (over all training sessions) | Number of attended training sessions as percentages of total possible training sessions |
| Compliance rate | through study completion, an average of 9 months (over all training sessions) | Number of attended training minutes as percentages of the total possible training minutes |
| Recruitment rate | through study completion, an average of 9 months | Number of patients fitting to the inclusion exclusion (resp. exclusion) criteria as percentages of persons with TBI admitted in the hospital during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | With a tailored (self-made) usability questionnaire the patient satisfaction will be assessed. The questionnaire records how the participants felt about the training, how satisfied they were with the training and whether they would recommend the training to others. The questionnaire contains 13 questions (Yes-No questions, Likert-Scale, and open questions). Each item will be evaluated separately. |
| Improvement | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | Comparison of the entry level versus the highest achieved level in percentage (for following training parameters: i. length of stepping sequence, ii.beats/minute, iii. Stepping sequence complexity) |
| Training capacity | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | Number of taught patterns per training session |
| Physical and cognitive load | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | Physical and cognitive load assessed with the National Aeronautics and Space Administration-Task Load Index (NASA-TLX). The NASA-TLX is a self-report, multidimensional assessment tool that rates perceived workload in order to assess a task, a system, or other aspects of performance (in this case the StepIi trainings). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. Each subscale can be given a score between 0 and 20. A higher score reflects a higher workload. |
Countries
Switzerland
Outcome results
None listed