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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04910217
• Other study ID #: FNO-Lokowalkers-2021
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The main aim is to determine, whether the RAGT by using the Lokomat exoskeleton device (Hoccoma, Switzerland) plus the protocol-defined conventional rehabilitation versus conventional rehabilitation improves the gait of post-stroke patients after 6 months. Both groups are treated with the protocol-defined rehabilitation (ergotherapy and physiotherapy) for 60 min 5 times a week, a total of 15 times within 3 weeks (a total of 1200 min). The Lokowalkers group undergoes the RAGT using the Lokomat Pro Freed device for 20-50 minutes 5 times a week for a total of 15 times for 3 weeks (a total of 1800 minutes). The primary endpoint is the Functional Ambulation Category (FAC) after 3 months. Secondary endpoints include FAC (after 15th therapy), 10-meter walk test (10MWT) (after 15th therapy, after 3 months), Timed Up and Go Test (TUG) (after 15th therapy and after 3 months, 3-months modified Rankin Scale (mRS), and Berg Balance Scale (BBS, after 15th therapy, after 3 months).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Conventional rehabilitation
Patients will undergo conventional rehabilitation
• Leg/lower body exerciser device intervention.
Patients will undergo leg/lower body exerciser device therapy.
• Lokomat intervention
Patients will undergo therapy with Lokomat Pro FreeD device intervention.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Ostrava	Masaryk University, VSB - Technical University of Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. Erratum In: J Neuroeng Rehabil. 2019 Jun 11;16(1):74. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Stroke. 2017 Feb;48(2):e78. Stroke. 2017 Dec;48(12 ):e369. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Ambulation Category (FAC) (after 3 weeks)	Functional Ambulation Category (FAC) - the scale range is from 0 to 5. The value after 3 weeks will be observed.	3 weeks
Secondary	10-meter walk test (10-MWT) (after 3 weeks and 3 months)	10-meter walk test will be performed after 3 weeks and 3 months	up to 3 months
Secondary	Timed Up and Go Test (TUG) (after 3 weeks, after 3 months)	Timed Up and Go Test (TUG) will be performed after 3 weeks, after 3 months	up to 3 months
Secondary	3-months modified Rankin Scale (mRS)	3-months modified Rankin Scale (mRS) assesses the functional independence and represents a standard outcome measure in post-stroke patients (range from 0 to 6).	up to 3 months
Secondary	Berg Balance Scale (BBS, after 3 weeks, after 3 months)	Berg Balance Scale (BBS) objectifies balance functions in 14 tasks. It assesses the risk of possible falls: 0-20 high, 21-40 medium, 41-56 low risk of falling.	up to 3 months
Secondary	Adverse effects	The number and character of adverse effects will be observed during the study.	up to 3 years
Secondary	Early termination of the study	The number of patients terminating the study early will be observed during the study.	up to 3 years
Secondary	Reason/s for the termination	The reason/s for the termination will be observed during the study.	up to 3 years
Secondary	Study-related death or death unrelated to study	The number of study-related deaths or deaths unrelated to study will be observed during the study.	up to 3 years