Clinical trial NCT06149975: Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury
Official title: Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury During Acute Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: motor-cognitive training
dual-task
TBI
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital St. Gallen
First posted: 2023-11-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: through study completion, an average of 9 months
measure: Inclusion rate
timeFrame: through study completion, an average of 9 months
measure: Attrition rate
timeFrame: through study completion, an average of 9 months
measure: Adherence rate
timeFrame: through study completion, an average of 9 months (over all training sessions)
measure: Compliance rate
timeFrame: through study completion, an average of 9 months (over all training sessions)
measure: Security incidents
timeFrame: through study completion, an average of 9 months (over all training sessions)
Secondary outcomes:
measure: Physical and cognitive load
timeFrame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
measure: Patient Satisfaction
timeFrame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
measure: Improvement
timeFrame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
measure: Training capacity
timeFrame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Cantonal Hospital of St. Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Anne-Katrin Hickmann, PD Dr.
role: STUDY_DIRECTOR
References:
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