New Technologies in the Rehabilitation of Chronic Stroke

NCT03641651 | Completed Results FDA Device

• 1 other identifier: ZHAW-SRTI
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high. The evaluation focuses on feasibility and cost-benefit analyses

Conditions

Stroke; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Correlation Between Scheduled and Performed Trainings

  Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.

  4 weeks

Secondary Outcomes (7)

• Functional Independence Measurement (FIM) Generic Functional Performance

  Baseline and 4 weeks

• Stroke Impact Scale (SIS) Recovery

  Baseline and 4 weeks

• Box and Block Test

  Baseline and 4 weeks

• Functional Ambulation Categories (FAC)

  Baseline and 4 weeks

• 10m Walk Test= TMT Comfortable

  Baseline and 4 weeks

Study Arms (1)

Technology arm

EXPERIMENTAL

4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.

Other: Rehabilitation technology

Interventions

Rehabilitation technology OTHER

* Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. * With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). * A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. * The training can take place in an outpatient or inpatient setting. * Training will be organized in individual one-to-one or group session

Also known as: Lokomat, Erigo, Andago, Armeo (Boom, Senseo, Spring, Power), Valedo motion, Amadeo, Myro, NuStep, Bi-Manu Trainer, EksoGT, The Float, MOTOmed, Allegro

Technology arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with residual hemiparesis after cerebrovascular accident
• Up to 12 months after the event
• Primary rehabilitation terminated
• Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)
• General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician
• Understand written and spoken German language

You may not qualify if:

• Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as
• fixed joint contractures limiting range of motion
• non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis
• Specific absolute contraindication for the training with any of the respective devices:
• Improper fit of the device, including its harness to relevant extremity(ies)
• Contraindicated training position (standing, sitting)

Sponsors & Collaborators

• Markus Wirz: lead
• Klinik Lengg, Zurich: collaborator
• Reha Rheinfelden: collaborator
• Klinik Valens: collaborator
• Rehaklinik Zihlschlacht AG: collaborator

Study Sites (4)

Reha Rheinfelden

Rheinfelden, 4310, Switzerland

Location

Kliniken Valens

Valens, 7317, Switzerland

Location

Rehakliniken Zihlschlacht

Zihlschlacht, 8588, Switzerland

Location

Klinik Lengg AG

Zurich, 8008, Switzerland

Location

Related Publications (35)

• Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.

  PMID: 24756870 BACKGROUND

• Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.

  PMID: 24505342 BACKGROUND

• Langhorne P, Wagenaar R, Partridge C. Physiotherapy after stroke: more is better? Physiother Res Int. 1996;1(2):75-88. doi: 10.1002/pri.6120010204.

  PMID: 9238725 BACKGROUND

• Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.

  PMID: 26338433 BACKGROUND

• Knecht S, Rossmuller J, Unrath M, Stephan KM, Berger K, Studer B. Old benefit as much as young patients with stroke from high-intensity neurorehabilitation: cohort analysis. J Neurol Neurosurg Psychiatry. 2016 May;87(5):526-30. doi: 10.1136/jnnp-2015-310344. Epub 2015 Jun 11.

  PMID: 26069298 BACKGROUND

• Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X.

  PMID: 10421300 BACKGROUND

• Feys H, De Weerdt W, Verbeke G, Steck GC, Capiau C, Kiekens C, Dejaeger E, Van Hoydonck G, Vermeersch G, Cras P. Early and repetitive stimulation of the arm can substantially improve the long-term outcome after stroke: a 5-year follow-up study of a randomized trial. Stroke. 2004 Apr;35(4):924-9. doi: 10.1161/01.STR.0000121645.44752.f7. Epub 2004 Mar 4.

  PMID: 15001789 BACKGROUND

• Jette DU, Warren RL, Wirtalla C. The relation between therapy intensity and outcomes of rehabilitation in skilled nursing facilities. Arch Phys Med Rehabil. 2005 Mar;86(3):373-9. doi: 10.1016/j.apmr.2004.10.018.

  PMID: 15759214 BACKGROUND

• Lohse KR, Lang CE, Boyd LA. Is more better? Using metadata to explore dose-response relationships in stroke rehabilitation. Stroke. 2014 Jul;45(7):2053-8. doi: 10.1161/STROKEAHA.114.004695. Epub 2014 May 27.

  PMID: 24867924 BACKGROUND

• Birkenmeier RL, Prager EM, Lang CE. Translating animal doses of task-specific training to people with chronic stroke in 1-hour therapy sessions: a proof-of-concept study. Neurorehabil Neural Repair. 2010 Sep;24(7):620-35. doi: 10.1177/1545968310361957. Epub 2010 Apr 27.

  PMID: 20424192 BACKGROUND

• Kwakkel G, van Peppen R, Wagenaar RC, Wood Dauphinee S, Richards C, Ashburn A, Miller K, Lincoln N, Partridge C, Wellwood I, Langhorne P. Effects of augmented exercise therapy time after stroke: a meta-analysis. Stroke. 2004 Nov;35(11):2529-39. doi: 10.1161/01.STR.0000143153.76460.7d. Epub 2004 Oct 7.

  PMID: 15472114 BACKGROUND

• Teasell R, Bitensky J, Salter K, Bayona NA. The role of timing and intensity of rehabilitation therapies. Top Stroke Rehabil. 2005 Summer;12(3):46-57. doi: 10.1310/ETDP-6DR4-D617-VMVF.

  PMID: 16110427 BACKGROUND

• Andrews AW, Li D, Freburger JK. Association of Rehabilitation Intensity for Stroke and Risk of Hospital Readmission. Phys Ther. 2015 Dec;95(12):1660-7. doi: 10.2522/ptj.20140610. Epub 2015 Jun 18.

  PMID: 26089042 BACKGROUND

• Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30.

  PMID: 22466792 BACKGROUND

• De Wit L, Putman K, Dejaeger E, Baert I, Berman P, Bogaerts K, Brinkmann N, Connell L, Feys H, Jenni W, Kaske C, Lesaffre E, Leys M, Lincoln N, Louckx F, Schuback B, Schupp W, Smith B, De Weerdt W. Use of time by stroke patients: a comparison of four European rehabilitation centers. Stroke. 2005 Sep;36(9):1977-83. doi: 10.1161/01.STR.0000177871.59003.e3. Epub 2005 Aug 4.

  PMID: 16081860 BACKGROUND

• De Wit L, Putman K, Schuback B, Komarek A, Angst F, Baert I, Berman P, Bogaerts K, Brinkmann N, Connell L, Dejaeger E, Feys H, Jenni W, Kaske C, Lesaffre E, Leys M, Lincoln N, Louckx F, Schupp W, Smith B, De Weerdt W. Motor and functional recovery after stroke: a comparison of 4 European rehabilitation centers. Stroke. 2007 Jul;38(7):2101-7. doi: 10.1161/STROKEAHA.107.482869. Epub 2007 May 31.

  PMID: 17540968 BACKGROUND

• Hayward KS, Brauer SG. Dose of arm activity training during acute and subacute rehabilitation post stroke: a systematic review of the literature. Clin Rehabil. 2015 Dec;29(12):1234-43. doi: 10.1177/0269215514565395. Epub 2015 Jan 7.

  PMID: 25568073 BACKGROUND

• Lang CE, Macdonald JR, Reisman DS, Boyd L, Jacobson Kimberley T, Schindler-Ivens SM, Hornby TG, Ross SA, Scheets PL. Observation of amounts of movement practice provided during stroke rehabilitation. Arch Phys Med Rehabil. 2009 Oct;90(10):1692-8. doi: 10.1016/j.apmr.2009.04.005.

  PMID: 19801058 BACKGROUND

• Lang CE, Wagner JM, Edwards DF, Dromerick AW. Upper extremity use in people with hemiparesis in the first few weeks after stroke. J Neurol Phys Ther. 2007 Jun;31(2):56-63. doi: 10.1097/NPT.0b013e31806748bd.

  PMID: 17558358 BACKGROUND

• Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.

  PMID: 8466415 BACKGROUND

• Gresham GE, Fitzpatrick TE, Wolf PA, McNamara PM, Kannel WB, Dawber TR. Residual disability in survivors of stroke--the Framingham study. N Engl J Med. 1975 Nov 6;293(19):954-6. doi: 10.1056/NEJM197511062931903.

  PMID: 1178004 BACKGROUND

• Johnson BH, Bonafede MM, Watson C. Short- and longer-term health-care resource utilization and costs associated with acute ischemic stroke. Clinicoecon Outcomes Res. 2016 Feb 23;8:53-61. doi: 10.2147/CEOR.S95662. eCollection 2016.

  PMID: 26966382 BACKGROUND

• McGuire AJ, Raikou M, Whittle I, Christensen MC. Long-term mortality, morbidity and hospital care following intracerebral hemorrhage: an 11-year cohort study. Cerebrovasc Dis. 2007;23(2-3):221-8. doi: 10.1159/000097645. Epub 2006 Dec 1.

  PMID: 17143007 BACKGROUND

• Taylor TN, Davis PH, Torner JC, Holmes J, Meyer JW, Jacobson MF. Lifetime cost of stroke in the United States. Stroke. 1996 Sep;27(9):1459-66. doi: 10.1161/01.str.27.9.1459.

  PMID: 8784113 BACKGROUND

• Zhao Y, Condon J, Lawton P, He V, Cadilhac DA. Lifetime direct costs of stroke for indigenous patients adjusted for comorbidities. Neurology. 2016 Aug 2;87(5):458-65. doi: 10.1212/WNL.0000000000002908. Epub 2016 Jul 1.

  PMID: 27371489 BACKGROUND

• Duret C, Hutin E, Lehenaff L, Gracies JM. Do all sub acute stroke patients benefit from robot-assisted therapy? A retrospective study. Restor Neurol Neurosci. 2015;33(1):57-65. doi: 10.3233/RNN-140418.

  PMID: 25420902 BACKGROUND

• Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.

  PMID: 20400552 BACKGROUND

• Spiess MR, Jaramillo JP, Behrman AL, Teraoka JK, Patten C. Unexpected recovery after robotic locomotor training at physiologic stepping speed: a single-case design. Arch Phys Med Rehabil. 2012 Aug;93(8):1476-84. doi: 10.1016/j.apmr.2012.02.030. Epub 2012 Mar 23.

  PMID: 22446153 BACKGROUND

• Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.

  PMID: 24396811 BACKGROUND

• Masiero S, Poli P, Rosati G, Zanotto D, Iosa M, Paolucci S, Morone G. The value of robotic systems in stroke rehabilitation. Expert Rev Med Devices. 2014 Mar;11(2):187-98. doi: 10.1586/17434440.2014.882766. Epub 2014 Jan 30.

  PMID: 24479445 BACKGROUND

• Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. doi: 10.1682/jrrd.2010.04.0055.

  PMID: 21674390 BACKGROUND

• Waldner A, Tomelleri C, Hesse S. Transfer of scientific concepts to clinical practice: recent robot-assisted training studies. Funct Neurol. 2009 Oct-Dec;24(4):173-7.

  PMID: 20412721 BACKGROUND

• Babaiasl M, Mahdioun SH, Jaryani P, Yazdani M. A review of technological and clinical aspects of robot-aided rehabilitation of upper-extremity after stroke. Disabil Rehabil Assist Technol. 2016;11(4):263-80. doi: 10.3109/17483107.2014.1002539. Epub 2015 Jan 20.

  PMID: 25600057 BACKGROUND

• Mehrholz J, Thomas S, Werner C, Kugler J, Pohl M, Elsner B. Electromechanical-Assisted Training for Walking After Stroke: A Major Update of the Evidence. Stroke. 2017 Jun 16:STROKEAHA.117.018018. doi: 10.1161/STROKEAHA.117.018018. Online ahead of print. No abstract available.

  PMID: 28626059 BACKGROUND

• Schuster-Amft C, Kool J, Moller JC, Schweinfurther R, Ernst MJ, Reicherzer L, Ziller C, Schwab ME, Wieser S, Wirz M; SRTI study group. Feasibility and cost description of highly intensive rehabilitation involving new technologies in patients with post-acute stroke-a trial of the Swiss RehabTech Initiative. Pilot Feasibility Stud. 2022 Jul 5;8(1):139. doi: 10.1186/s40814-022-01086-0.

  PMID: 35791026 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

frovatriptan

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Dr. Markus Wirz
• Organization: Zurich University of applied sciences

markus.wirz@zhaw.ch

+41 58 934

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Physiotherapy R&D

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 22, 2018
• Study Start: August 31, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 27, 2022
• Results First Posted: September 27, 2022

Record last verified: 2022-09

Locations

CH (4)