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

July 1, 2024 updated by: Eleftheria Giannouli, Swiss Federal Institute of Technology

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Saint Gallen, Switzerland, 9000
        • Cantonal Hospital of St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 9 months
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
through study completion, an average of 9 months
Attrition rate
Time Frame: through study completion, an average of 9 months
Number of Drop-outs as percentages of patients included in the study
through study completion, an average of 9 months
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
through study completion, an average of 9 months (over all training sessions)
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
through study completion, an average of 9 months (over all training sessions)
Security incidents
Time Frame: through study completion, an average of 9 months (over all training sessions)
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
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.
through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
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.
through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
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)
through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
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
through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

Cantonal Hospital St. Gallen

Investigators

  • Study Director: Anne-Katrin Hickmann, PD Dr., Cantonal Hospital St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Actual)

June 13, 2024

Study Completion (Actual)

June 13, 2024

Study Registration Dates

First Submitted

October 22, 2023

First Submitted That Met QC Criteria

November 26, 2023

First Posted (Actual)

November 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StepIt TBI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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