Skip to main content
OpenTrials
Completed

NCT Number: NCT06149975

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital of St. Gallen

Sankt Gallen, 9000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

motor-cognitive training

Other

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 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

  2. Inclusion rate

    Time frame: 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

  3. Attrition rate

    Time frame: through study completion, an average of 9 months

    Number of Drop-outs as percentages of patients included in the study

  4. Adherence rate

    Time frame: through study completion, an average of 9 months (over all training sessions)

    Number of attended training sessions as percentages of total possible training sessions

  5. Compliance rate

    Time frame: 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

  6. Security incidents

    Time frame: through study completion, an average of 9 months (over all training sessions)

    Total number of (Serious) Adverse Events (SAE/AE)

Secondary outcomes

  1. Physical and cognitive load

    Time frame: 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.

  2. Patient Satisfaction

    Time frame: 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.

  3. Improvement

    Time frame: 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)

  4. Training capacity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Cantonal Hospital of St. Gallen

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.