Robot-Assisted Gait Therapy in the Subacute Phase of First Ischemic Stroke

NCT04910217 | Unknown

• 1 other identifier: FNO-Lokowalkers-2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Robot-assisted gait training (RAGT) represents a modern concept of neurorehabilitation in stroke patients. This single-center randomized parallel-group neurorehabilitation trial with blinded primary outcome assessment is aimed at patients after the first-ever ischaemic stroke in the anterior or posterior cerebral circulation.

Conditions

Ischemic Stroke

Keywords

gait; stroke; robotic rehabilitation; exoskeleton; neurorehabilitation; Lokomat

Outcome Measures

Primary Outcomes (1)

• Functional Ambulation Category (FAC) at 3 months

  Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value at 6-months will be observed.

  3 months

Secondary Outcomes (9)

• Functional Ambulation Category (FAC) (after 3 weeks)

  3 weeks

• 10-meter walk test (10-MWT) (after 3 weeks and 3 months)

  up to 3 months

• Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)

  up to 3 months

• 3-months modified Rankin Scale (mRS)

  up to 3 months

• Berg Balance Scale (BBS, after 3 weeks, after 3 months)

  up to 3 months

Study Arms (2)

Lokomat intervention

EXPERIMENTAL

Patients randomized into the Lokomat arm will undergo therapy with Lokomat Pro FreeD for 20-50 minutes 5-times a week, a total of 15-times during the in-hospital stay in a total time of 1,800 minutes.

Procedure: Conventional rehabilitation; Procedure: Lokomat intervention

Conventional rehabilitation

EXPERIMENTAL

Patients in this arm will undergo conventional rehabilitation ((ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min)

Procedure: Conventional rehabilitation; Procedure: Leg/lower body exerciser device intervention.

Interventions

Conventional rehabilitation PROCEDURE

Patients will undergo conventional rehabilitation

Conventional rehabilitation; Lokomat intervention

Leg/lower body exerciser device intervention. PROCEDURE

Patients will undergo leg/lower body exerciser device therapy.

Conventional rehabilitation

Lokomat intervention PROCEDURE

Patients will undergo therapy with Lokomat Pro FreeD device intervention.

Lokomat intervention

Eligibility Criteria

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

You may qualify if:

• signed informed consent by the participant or legal representative
• interval between stroke and first rehabilitation session \< 6 weeks (study target within 2 weeks)
• age \> 18 years
• early modified Rankin scale (mRS) 2 to 4 (pre-stroke mRS 0 to 1)
• early FAC of 0 to 3 (pre-stroke FAC of 5)
• standing ability with support up to 3 minutes and vertical tolerance \> 15 minutes

You may not qualify if:

• inability or refusal to sign an informed consent
• history of stroke or another brain disease (tumour, multiple sclerosis, brain or spinal cord injury)
• severe internal, oncological, or surgical comorbidity preventing long-term re-habilitation or causing chronic or progressive gait disorder
• limited collaboration of any reason, moderate or severe dementia assessed by using the Montreal Cognitive Assessment (MoCA) scale
• impaired skin integrity in the lower torso and limbs preventing the use of Lokomat device
• limitations given by the Lokomat exoskeleton device (weight \> 135 kg, thigh-length 23-35 cm, shank length 35-47cm)
• limitations given by the leg/lower body exerciser (weight \> 180 kg, height \< 120 cm or \> 200 cm, (sub)acute lower limb fractures, deep vein thrombosis, skin disintegration)
• any contraindication to perform brain MRI

Sponsors & Collaborators

• University Hospital Ostrava: lead
• Masaryk University: collaborator
• VSB - Technical University of Ostrava: collaborator

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (22)

• Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.

  PMID: 17908575 BACKGROUND

• Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1.

  PMID: 21964750 BACKGROUND

• Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.

  PMID: 27145936 BACKGROUND

• Maier M, Ballester BR, Verschure PFMJ. Principles of Neurorehabilitation After Stroke Based on Motor Learning and Brain Plasticity Mechanisms. Front Syst Neurosci. 2019 Dec 17;13:74. doi: 10.3389/fnsys.2019.00074. eCollection 2019.

  PMID: 31920570 BACKGROUND

• Morone G, Paolucci S, Cherubini A, De Angelis D, Venturiero V, Coiro P, Iosa M. Robot-assisted gait training for stroke patients: current state of the art and perspectives of robotics. Neuropsychiatr Dis Treat. 2017 May 15;13:1303-1311. doi: 10.2147/NDT.S114102. eCollection 2017.

  PMID: 28553117 BACKGROUND

• Moucheboeuf G, Griffier R, Gasq D, Glize B, Bouyer L, Dehail P, Cassoudesalle H. Effects of robotic gait training after stroke: A meta-analysis. Ann Phys Rehabil Med. 2020 Nov;63(6):518-534. doi: 10.1016/j.rehab.2020.02.008. Epub 2020 Mar 27.

  PMID: 32229177 BACKGROUND

• Jorgensen HS, Nakayama H, Raaschou HO, Olsen TS. Recovery of walking function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1995 Jan;76(1):27-32. doi: 10.1016/s0003-9993(95)80038-7.

  PMID: 7811170 BACKGROUND

• Bruni MF, Melegari C, De Cola MC, Bramanti A, Bramanti P, Calabro RS. What does best evidence tell us about robotic gait rehabilitation in stroke patients: A systematic review and meta-analysis. J Clin Neurosci. 2018 Feb;48:11-17. doi: 10.1016/j.jocn.2017.10.048. Epub 2017 Dec 6.

  PMID: 29208476 BACKGROUND

• Kim MS, Kim SH, Noh SE, Bang HJ, Lee KM. Robotic-Assisted Shoulder Rehabilitation Therapy Effectively Improved Poststroke Hemiplegic Shoulder Pain: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Jun;100(6):1015-1022. doi: 10.1016/j.apmr.2019.02.003. Epub 2019 Mar 13.

  PMID: 30878496 BACKGROUND

• Mehrholz J, Thomas S, Kugler J, Pohl M, Elsner B. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD006185. doi: 10.1002/14651858.CD006185.pub5.

  PMID: 33091160 BACKGROUND

• Zaidi SF, Aghaebrahim A, Urra X, Jumaa MA, Jankowitz B, Hammer M, Nogueira R, Horowitz M, Reddy V, Jovin TG. Final infarct volume is a stronger predictor of outcome than recanalization in patients with proximal middle cerebral artery occlusion treated with endovascular therapy. Stroke. 2012 Dec;43(12):3238-44. doi: 10.1161/STROKEAHA.112.671594. Epub 2012 Nov 15.

  PMID: 23160876 BACKGROUND

• Bucker A, Boers AM, Bot JCJ, Berkhemer OA, Lingsma HF, Yoo AJ, van Zwam WH, van Oostenbrugge RJ, van der Lugt A, Dippel DWJ, Roos YBWEM, Majoie CBLM, Marquering HA; MR CLEAN Trial Investigators (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). Associations of Ischemic Lesion Volume With Functional Outcome in Patients With Acute Ischemic Stroke: 24-Hour Versus 1-Week Imaging. Stroke. 2017 May;48(5):1233-1240. doi: 10.1161/STROKEAHA.116.015156. Epub 2017 Mar 28.

  PMID: 28351963 BACKGROUND

• Aurich-Schuler T, Gut A, Labruyere R. The FreeD module for the Lokomat facilitates a physiological movement pattern in healthy people - a proof of concept study. J Neuroeng Rehabil. 2019 Feb 6;16(1):26. doi: 10.1186/s12984-019-0496-x.

  PMID: 30728040 BACKGROUND

• Bower K, Thilarajah S, Pua YH, Williams G, Tan D, Mentiplay B, Denehy L, Clark R. Dynamic balance and instrumented gait variables are independent predictors of falls following stroke. J Neuroeng Rehabil. 2019 Jan 7;16(1):3. doi: 10.1186/s12984-018-0478-4.

  PMID: 30612584 BACKGROUND

• Heinemann AW, Linacre JM, Wright BD, Hamilton BB, Granger C. Relationships between impairment and physical disability as measured by the functional independence measure. Arch Phys Med Rehabil. 1993 Jun;74(6):566-73. doi: 10.1016/0003-9993(93)90153-2.

  PMID: 8503745 BACKGROUND

• Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.

  PMID: 1468055 BACKGROUND

• Anderson C, Laubscher S, Burns R. Validation of the Short Form 36 (SF-36) health survey questionnaire among stroke patients. Stroke. 1996 Oct;27(10):1812-6. doi: 10.1161/01.str.27.10.1812.

  PMID: 8841336 BACKGROUND

• Park IJ, Park JH, Seong HY, You JSH, Kim SJ, Min JH, Ko HY, Shin YI. Comparative Effects of Different Assistance Force During Robot-Assisted Gait Training on Locomotor Functions in Patients With Subacute Stroke: An Assessor-Blind, Randomized Controlled Trial. Am J Phys Med Rehabil. 2019 Jan;98(1):58-64. doi: 10.1097/PHM.0000000000001027.

  PMID: 30142092 BACKGROUND

• Barca C, Foray C, Hermann S, Doring C, Schafers M, Jacobs AH, Zinnhardt B. Characterization of the inflammatory post-ischemic tissue by full volumetric analysis of a multimodal imaging dataset. Neuroimage. 2020 Nov 15;222:117217. doi: 10.1016/j.neuroimage.2020.117217. Epub 2020 Jul 31.

  PMID: 32745676 BACKGROUND

• Baudat C, Marechal B, Corredor-Jerez R, Kober T, Meuli R, Hagmann P, Michel P, Maeder P, Dunet V. Automated MRI-based volumetry of basal ganglia and thalamus at the chronic phase of cortical stroke. Neuroradiology. 2020 Nov;62(11):1371-1380. doi: 10.1007/s00234-020-02477-x. Epub 2020 Jun 17.

  PMID: 32556424 BACKGROUND

• Bernarding J, Braun J, Hohmann J, Mansmann U, Hoehn-Berlage M, Stapf C, Wolf KJ, Tolxdorff T. Histogram-based characterization of healthy and ischemic brain tissues using multiparametric MR imaging including apparent diffusion coefficient maps and relaxometry. Magn Reson Med. 2000 Jan;43(1):52-61. doi: 10.1002/(sici)1522-2594(200001)43:13.0.co;2-5.

  PMID: 10642731 BACKGROUND

• Fiedorova I, Banikova S, Adamec T, Konde A, Hanzlikova P, Ganesh A, Bar M, Volny O. Robot-Assisted Gait Therapy in the Subacute Phase of Ischemic Stroke: A Randomized Controlled Trial. Ann Indian Acad Neurol. 2025 Nov 28. doi: 10.4103/aian.aian_526_25. Online ahead of print.

  PMID: 41313041 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ondřej Volný, MD,PhD,FESO

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-centre randomized parallel group neurorehabilitation trial

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 2, 2021
• Study Start: May 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)