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

NCT06149975 | Completed

• 1 other identifier: StepIt TBI
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

motor-cognitive training; dual-task; TBI

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Physical and cognitive load

  through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))

• Patient Satisfaction

  through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))

• Improvement

  through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))

• Training capacity

  through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Cantonal Hospital of St. Gallen: collaborator

Study Sites (1)

Cantonal Hospital of St. Gallen

Sankt Gallen, 9000, Switzerland

Location

Related Publications (14)

• Menon DK, Schwab K, Wright DW, Maas AI; Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1637-40. doi: 10.1016/j.apmr.2010.05.017.

  PMID: 21044706 BACKGROUND

• Brazinova A, Rehorcikova V, Taylor MS, Buckova V, Majdan M, Psota M, Peeters W, Feigin V, Theadom A, Holkovic L, Synnot A. Epidemiology of Traumatic Brain Injury in Europe: A Living Systematic Review. J Neurotrauma. 2021 May 15;38(10):1411-1440. doi: 10.1089/neu.2015.4126. Epub 2018 Dec 19.

  PMID: 26537996 BACKGROUND

• Galea OA, Cottrell MA, Treleaven JM, O'Leary SP. Sensorimotor and Physiological Indicators of Impairment in Mild Traumatic Brain Injury: A Meta-Analysis. Neurorehabil Neural Repair. 2018 Feb;32(2):115-128. doi: 10.1177/1545968318760728.

  PMID: 29554850 BACKGROUND

• Rabinowitz AR, Levin HS. Cognitive sequelae of traumatic brain injury. Psychiatr Clin North Am. 2014 Mar;37(1):1-11. doi: 10.1016/j.psc.2013.11.004. Epub 2014 Jan 14.

  PMID: 24529420 BACKGROUND

• Berkner J, Meehan WP 3rd, Master CL, Howell DR. Gait and Quiet-Stance Performance Among Adolescents After Concussion-Symptom Resolution. J Athl Train. 2017 Dec;52(12):1089-1095. doi: 10.4085/1062-6050-52.11.23. Epub 2017 Nov 20.

  PMID: 29154694 BACKGROUND

• Spano B, De Tollis M, Taglieri S, Manzo A, Ricci C, Lombardi MG, Polidori L, Griffini IA, Aloisi M, Vinicola V, Formisano R, Caltagirone C, Annicchiarico R. The Effect of Dual-Task Motor-Cognitive Training in Adults with Neurological Diseases Who Are at Risk of Falling. Brain Sci. 2022 Sep 7;12(9):1207. doi: 10.3390/brainsci12091207.

  PMID: 36138943 BACKGROUND

• Giannouli E, Morat T, Zijlstra W. A Novel Square-Stepping Exercise Program for Older Adults (StepIt): Rationale and Implications for Falls Prevention. Front Med (Lausanne). 2020 Jan 14;6:318. doi: 10.3389/fmed.2019.00318. eCollection 2019.

  PMID: 31993435 BACKGROUND

• Fritz NE, Basso DM. Dual-task training for balance and mobility in a person with severe traumatic brain injury: a case study. J Neurol Phys Ther. 2013 Mar;37(1):37-43. doi: 10.1097/NPT.0b013e318282a20d.

  PMID: 23364169 BACKGROUND

• Zhou Q, Yang H, Zhou Q, Pan H. Effects of cognitive motor dual-task training on stroke patients: A RCT-based meta-analysis. J Clin Neurosci. 2021 Oct;92:175-182. doi: 10.1016/j.jocn.2021.08.009. Epub 2021 Aug 25.

  PMID: 34509248 BACKGROUND

• Silva RDN, Afonso SV, Felipe LR, Oliveira RA, Patrizzi Martins LJ, Pascucci Sande de Souza LA. Dual-task intervention based on trail making test: Effects on Parkinson's disease. J Bodyw Mov Ther. 2021 Jul;27:628-633. doi: 10.1016/j.jbmt.2021.04.013. Epub 2021 May 4.

  PMID: 34391298 BACKGROUND

• Yang YR, Chen YC, Lee CS, Cheng SJ, Wang RY. Dual-task-related gait changes in individuals with stroke. Gait Posture. 2007 Feb;25(2):185-90. doi: 10.1016/j.gaitpost.2006.03.007. Epub 2006 May 2.

  PMID: 16650766 BACKGROUND

• Liu YC, Yang YR, Tsai YA, Wang RY. Cognitive and motor dual task gait training improve dual task gait performance after stroke - A randomized controlled pilot trial. Sci Rep. 2017 Jun 22;7(1):4070. doi: 10.1038/s41598-017-04165-y.

  PMID: 28642466 BACKGROUND

• Spano B, Lombardi MG, De Tollis M, Szczepanska MA, Ricci C, Manzo A, Giuli S, Polidori L, Griffini IA, Adriano F, Caltagirone C, Annicchiarico R. Effect of Dual-Task Motor-Cognitive Training in Preventing Falls in Vulnerable Elderly Cerebrovascular Patients: A Pilot Study. Brain Sci. 2022 Jan 27;12(2):168. doi: 10.3390/brainsci12020168.

  PMID: 35203932 BACKGROUND

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Anne-Katrin Hickmann, PD Dr.

  Cantonal Hospital of St. Gallen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: November 29, 2023
• Study Start: November 20, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

CH (1)