Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury During Acute Hospitalization

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: motor-cognitive training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Other: motor-cognitive training<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | 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 | through study completion, an average of 9 months | 
| Inclusion rate | Number of patients included in the study as percentages of patients fitting to the inclusion (resp. exclusion) criteria | through study completion, an average of 9 months | 
| Attrition rate | Number of Drop-outs as percentages of patients included in the study | through study completion, an average of 9 months | 
| Adherence rate | Number of attended training sessions as percentages of total possible training sessions | through study completion, an average of 9 months (over all training sessions) | 
| Compliance rate | Number of attended training minutes as percentages of the total possible training minutes | through study completion, an average of 9 months (over all training sessions) | 
| Security incidents | Total number of (Serious) Adverse Events (SAE/AE) | through study completion, an average of 9 months (over all training sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical and cognitive load | 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. | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | 
| Patient Satisfaction | 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. | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | 
| Improvement | 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) | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | 
| Training capacity | Number of taught patterns per training session | through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times)) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual-task, motor-cognitive training, TBI