Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study

NCT05598892 | Completed

• 1 other identifier: CorporacionRCLCS0008
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The following study seeks to provide information regarding to the RobHand exoskeleton for hand neuromotor maintenance and/or rehabilitation, developed by the University of Valladolid, Spain.

Conditions

Stroke

Keywords

Stroke; Hand Rehabilitation; Exoskeleton

Outcome Measures

Primary Outcomes (2)

• Dynamometry - Grip Baseline

  A Jamar hydraulic hand dynamometer (Pennsylvania, USA) was used to assess isometric contractions. This test allows to evaluate the functional integrity of the upper extremity through the force exerted when squeezing the hand and therefore,to identify the loss of physiological muscle function. The patient is asked to grasp the resistance of the handle, place his shoulder in abduction and with neutral rotation. Additionally, the elbow must be flexed at 90º and with the forearm in a neutral position.

  Baseline

• Dynamometry - Grip Post Intervention

  A Jamar hydraulic hand dynamometer (Pennsylvania, USA) was used to assess isometric contractions. This test allows to evaluate the functional integrity of the upper extremity through the force exerted when squeezing the hand and therefore,to identify the loss of physiological muscle function. The patient is asked to grasp the resistance of the handle, place his shoulder in abduction and with neutral rotation. Additionally, the elbow must be flexed at 90º and with the forearm in a neutral position.

  8 weeks

Secondary Outcomes (2)

• Nine Hole Peg Test (9-HPT) Baseline

  Baseline

• Nine Hole Peg Test (9-HPT) Post Intervention

  8 weeks

Study Arms (1)

Robot-assisted Rehabilitation

EXPERIMENTAL

Participants will receive rehabilitation based on hand robotic exosqueleton (ROBHAND, ITAP Valladolid, Spain) Patients will perform upper limb exercises assisted by the device. Training involve 16 sessions, 2 sessions per week for 8 weeks, each lasting about 60 minutes.

Device: Training with Robotic Hand Exoskeleton

Interventions

Training with Robotic Hand Exoskeleton DEVICE

The intervention consists in Robotic Hand training sessions. Each subject received 16 sessions lasting 60 minutes each and a frequency of 2 sessions per week. The sessions will be applied by an Ocupational Therapist with experience in Robotic training. Robhand exoskeleton (ITAP, Valladolid, Spain) is an exoskeleton-type electromechanical device, which is attached to the patient's hand and provides assistance for performing different types of finger movement rehabilitation therapies. The exoskeleton is composed of five independent subassemblies that are placed on a platform which is located on the back of the hand, with the exception of the thumb subassembly that is mounted on a separated module connected to the hand support platform through a linkage device.

Robot-assisted Rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Active patient at the Rehabilitation Center Club de Leones Cruz del Sur
• At least 1 Hemorrhagic or ischemic stroke
• Adequate level of consciousness
• Paresis of the upper extremities
• Patient who signed the inform consent

You may not qualify if:

• Comorbidities in the central nervous system
• Pain in the upper extremity (hand, forearm, arm)
• Patient who does not sign the informed consent

Sponsors & Collaborators

• Corporación de Rehabilitación Club de Leones Cruz del Sur: lead
• University of Valladolid: collaborator
• Universidad de Magallanes: collaborator

Study Sites (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

Location

Related Publications (51)

• GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.

  PMID: 30871944 BACKGROUND

• Málaga, G., La Cruz-Saldaña, D., Busta-Flores, P., Carbajal, A., & Santiago-Mariaca, K. (2018). La enfermedad cerebrovascular en el Perú: estado actual y perspectivas de investigación clínica. Acta medica peruana, 35(1), 51-54.

  BACKGROUND

• Leyton Pavez, C.E., Espinoza, I.R.P., Hernández Poblete, P.A., Gil Martín, J.C.: Atención post hospitalaria de pacientes con accidente cerebrovascular en atención primaria de salud. Revista Médica de Risaralda 25, 23-30 (2019)

  BACKGROUND

• Sepúlveda-Contreras, J.: Caracterización de pacientes con accidente cerebrovascular ingresados en un hospital de baja complejidad en Chile. Universidad y Salud 23, 8-12 (2021)

  BACKGROUND

• Rathore SS, Hinn AR, Cooper LS, Tyroler HA, Rosamond WD. Characterization of incident stroke signs and symptoms: findings from the atherosclerosis risk in communities study. Stroke. 2002 Nov;33(11):2718-21. doi: 10.1161/01.str.0000035286.87503.31.

  PMID: 12411667 BACKGROUND

• Fischer HC, Stubblefield K, Kline T, Luo X, Kenyon RV, Kamper DG. Hand rehabilitation following stroke: a pilot study of assisted finger extension training in a virtual environment. Top Stroke Rehabil. 2007 Jan-Feb;14(1):1-12. doi: 10.1310/tsr1401-1.

  PMID: 17311785 BACKGROUND

• Thibaut A, Chatelle C, Ziegler E, Bruno MA, Laureys S, Gosseries O. Spasticity after stroke: physiology, assessment and treatment. Brain Inj. 2013;27(10):1093-105. doi: 10.3109/02699052.2013.804202. Epub 2013 Jul 25.

  PMID: 23885710 BACKGROUND

• Beneitez García, P.: Neurorrehabilitación: Robótica Y Realidad Virtual en Accidente Cerebrovascular. Reeducación del Miembro Superior, (2019). http://hdl.handle.net/10810/31072

  BACKGROUND

• Rossini PM, Calautti C, Pauri F, Baron JC. Post-stroke plastic reorganisation in the adult brain. Lancet Neurol. 2003 Aug;2(8):493-502. doi: 10.1016/s1474-4422(03)00485-x.

  PMID: 12878437 BACKGROUND

• Nudo RJ, Wise BM, SiFuentes F, Milliken GW. Neural substrates for the effects of rehabilitative training on motor recovery after ischemic infarct. Science. 1996 Jun 21;272(5269):1791-4. doi: 10.1126/science.272.5269.1791.

  PMID: 8650578 BACKGROUND

• Jones EG. Cortical and subcortical contributions to activity-dependent plasticity in primate somatosensory cortex. Annu Rev Neurosci. 2000;23:1-37. doi: 10.1146/annurev.neuro.23.1.1.

  PMID: 10845057 BACKGROUND

• Sterr A, Freivogel S. Motor-improvement following intensive training in low-functioning chronic hemiparesis. Neurology. 2003 Sep 23;61(6):842-4. doi: 10.1212/wnl.61.6.842.

  PMID: 14504336 BACKGROUND

• Butefisch C, Hummelsheim H, Denzler P, Mauritz KH. Repetitive training of isolated movements improves the outcome of motor rehabilitation of the centrally paretic hand. J Neurol Sci. 1995 May;130(1):59-68. doi: 10.1016/0022-510x(95)00003-k.

  PMID: 7650532 BACKGROUND

• Levy CE, Nichols DS, Schmalbrock PM, Keller P, Chakeres DW. Functional MRI evidence of cortical reorganization in upper-limb stroke hemiplegia treated with constraint-induced movement therapy. Am J Phys Med Rehabil. 2001 Jan;80(1):4-12. doi: 10.1097/00002060-200101000-00003.

  PMID: 11138954 BACKGROUND

• Frick EM, Alberts JL. Combined use of repetitive task practice and an assistive robotic device in a patient with subacute stroke. Phys Ther. 2006 Oct;86(10):1378-86. doi: 10.2522/ptj.20050149.

  PMID: 17012642 BACKGROUND

• Panagiotis, P., Zheng, W., Kevin C., G., Robert J., W., Conor J., W.: Soft robotic glove for combined assistance and at-home rehabilitation. Robotics and Autonomous Systems 73(Wearable Robotics), 135-143 (2015). doi:10.1016/j.robot.2014.08.014

  BACKGROUND

• Ates, S., Haarman, C.J.W., Stienen, A.H.A.: SCRIPT passive orthosis: design of interactive hand and wrist exoskeleton for rehabilitation at home after stroke. Autonomous Robots 41(3), 711-723 (2017). doi:10.1007/s10514-016-9589-6

  BACKGROUND

• Pelier, B.Y.N., Aguilar, M.T., Rabelo, J.N.: Terapia robótica en la rehabilitación del miembro superior hemipléjico en pacientes con enfermedad cerebrovascular. Medimay 28(1), 132-41 (2021)

  BACKGROUND

• Costa, , Díez, S.: Robótica para la rehabilitación. Sobre Ruedas 102, 16-20 (2019)

  BACKGROUND

• Gil-Castillo J, Barria P, Aguilar Cardenas R, Baleta Abarza K, Andrade Gallardo A, Biskupovic Mancilla A, Azorin JM, Moreno JC. A Robot-Assisted Therapy to Increase Muscle Strength in Hemiplegic Gait Rehabilitation. Front Neurorobot. 2022 Apr 29;16:837494. doi: 10.3389/fnbot.2022.837494. eCollection 2022.

  PMID: 35574230 BACKGROUND

• Mancisidor, A., Zubizarreta, A., Cabanes, I., Bengoa, P., Jung, J.H.: Dispositivo robótico multifuncional para la rehabilitación de las extremidades superiores. Revista Iberoamericana de Automática e Informática industrial 15(2), 180-91 (2018). doi:10.4995/riai.2017.8820

  BACKGROUND

• Carmeli E, Peleg S, Bartur G, Elbo E, Vatine JJ. HandTutor enhanced hand rehabilitation after stroke--a pilot study. Physiother Res Int. 2011 Dec;16(4):191-200. doi: 10.1002/pri.485. Epub 2010 Aug 25.

  PMID: 20740477 BACKGROUND

• Ueki, S., Kawasaki, H., Ito, S., Nishimoto, Y., Abe, M., Aoki, T., Ishigure, Y., Ojika, T., Mouri, T.:Development of a hand-assist robot with multi-degrees-of-freedom for rehabilitation therapy. IEEE/ASME Transactions on Mechatronics 17(1), 136-146 (2012). doi:10.1109/TMECH.2010.2090353

  BACKGROUND

• Kutner NG, Zhang R, Butler AJ, Wolf SL, Alberts JL. Quality-of-life change associated with robotic-assisted therapy to improve hand motor function in patients with subacute stroke: a randomized clinical trial. Phys Ther. 2010 Apr;90(4):493-504. doi: 10.2522/ptj.20090160. Epub 2010 Feb 25.

  PMID: 20185616 BACKGROUND

• Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.

  PMID: 17876068 BACKGROUND

• Rietman, J.S., Prange, G., Kottink, A., Ribbers, G., Buurke, J.: The Effect of an Arm Supporting Training Device in Sub-Acute Stroke Patients: Randomized Clinical Trial. Archives of Physical Medicine and Rehabilitation 95(10), 8 (2014). doi:10.1016/j.apmr.2014.07.382

  BACKGROUND

• Flores, E., Tobon, G., Cavallaro, E., Cavallaro, F.I., Perry, J.C., Keller, T.: Improving patient motivation in game development for motor deficit rehabilitation. Advances in Computer Entertaiment Technology, 381 (2009). doi:10.1145/1501750.1501839

  BACKGROUND

• Loureiro, R.C.V., Collin, C.F., Harwin, W.S.: Robot Aided Therapy: Challenges Ahead for Upper Limb Stroke Rehabilitation. In: 5th Intl. Conf. Disability, Virtual Reality Assoc. Tech., pp. 33-39 (2004).

  BACKGROUND

• Corbetta D, Imeri F, Gatti R. Rehabilitation that incorporates virtual reality is more effective than standard rehabilitation for improving walking speed, balance and mobility after stroke: a systematic review. J Physiother. 2015 Jul;61(3):117-24. doi: 10.1016/j.jphys.2015.05.017. Epub 2015 Jun 18.

  PMID: 26093805 BACKGROUND

• Cameirao, M.S., Badia, S.B.i., Zimmerli, L., Oller, E.D., Verschure, P.F.M.J.: The Rehabilitation Gaming System: a Virtual Reality Based System for the Evaluation and Rehabilitation of Motor Deficits. In: 2007 Virtual Rehabilitation, pp. 29-33. IEEE, ??? (2007). doi:10.1109/ICVR.2007.4362125.http://ieeexplore.ieee.org/document/4362125/

  BACKGROUND

• Sveistrup H. Motor rehabilitation using virtual reality. J Neuroeng Rehabil. 2004 Dec 10;1(1):10. doi: 10.1186/1743-0003-1-10.

  PMID: 15679945 BACKGROUND

• Nielsen JB, Willerslev-Olsen M, Christiansen L, Lundbye-Jensen J, Lorentzen J. Science-based neurorehabilitation: recommendations for neurorehabilitation from basic science. J Mot Behav. 2015;47(1):7-17. doi: 10.1080/00222895.2014.931273.

  PMID: 25575219 BACKGROUND

• Subramanian SK, Lourenco CB, Chilingaryan G, Sveistrup H, Levin MF. Arm motor recovery using a virtual reality intervention in chronic stroke: randomized control trial. Neurorehabil Neural Repair. 2013 Jan;27(1):13-23. doi: 10.1177/1545968312449695. Epub 2012 Jul 10.

  PMID: 22785001 BACKGROUND

• Crosbie, J.H., Crosbie, J.H., Lennon, S., Lennon, S., Mcgoldrick, M.C., Mcgoldrick, M.C., Mcneill, M.D.J., Mcneill, M.D.J., Burke, J.W., Burke, J.W., Mcdonough, S.M., Mcdonough, S.M.: Virtual reality in the rehabilitation of the upper limb after hemiplegic stroke: a randomised pilot study. Screen, 229-235 (2008)

  BACKGROUND

• Sainz-Cantero Paredes, J.A.: Montaje Y Control de Una ´ortesis Rob´otica Para la Rehabilitaci´on de la Mano, (2019). http://hdl.handle.net/10835/8020

  BACKGROUND

• Cisnal, A., Lobo, V., Moreno, V., Fraile, J.-C., Alonso, R., P´erez-Turiel, J.: Robhand, un exoesqueleto de mano para la rehabilitaci´on neuromotora aplicando terapias activas y pasivas. In: En Actas de las XXXIX Jornadas de Autom´atica, Badajoz, 5-7 de Septiembre de 2018, pp. 34-41 (2018). doi:10.17979/spudc.9788497497565.0034

  BACKGROUND

• Moreno-SanJuan, V., Cisnal, A., Fraile, J.-C., P´erez-Turiel, J., de-la-Fuente, E.: Design and characterization of a lightweight underactuated raca hand exoskeleton for neurorehabilitation. Robotics and Autonomous Systems 143, 103828 (2021). doi:10.1016/j.robot.2021.103828

  BACKGROUND

• Cisnal, A., P´erez-Turiel, J., Fraile, J.-C., Sierra, D., de la Fuente, E.: Robhand: A hand exoskeleton with real-time emg-driven embedded control. quantifying hand gesture recognition delays for bilateral rehabilitation. IEEE Access 9, 137809-137823 (2021). doi:10.1109/ACCESS.2021.3118281

  BACKGROUND

• Cisnal A, Moreno-SanJuan V, Fraile JC, Turiel JP, de-la-Fuente E, Sanchez-Brizuela G. Assessment of the Patient's Emotional Response with the RobHand Rehabilitation Platform: A Case Series Study. J Clin Med. 2022 Jul 30;11(15):4442. doi: 10.3390/jcm11154442.

  PMID: 35956063 BACKGROUND

• C, J., V´azquez, L., S´anchez, G., S, J.: Dinamometria de manos en estudiantes de merida, m´exico. Revista chilena de nutrici´on 39, 45-51 (2012). doi:10.4067/S0717-75182012000300007

  BACKGROUND

• Ong HL, Abdin E, Chua BY, Zhang Y, Seow E, Vaingankar JA, Chong SA, Subramaniam M. Hand-grip strength among older adults in Singapore: a comparison with international norms and associative factors. BMC Geriatr. 2017 Aug 4;17(1):176. doi: 10.1186/s12877-017-0565-6.

  PMID: 28778190 BACKGROUND

• Gilbertson, L., Barber-Lomax, S.: Power and pinch grip strength recorded using the hand-held jamar® dynamometer and b+l hydraulic pinch gauge: British normative data for adults. British Journal of Occupational Therapy 57(12), 483-488 (1994). doi:10.1177/030802269405701209. https://doi.org/10.1177/030802269405701209

  BACKGROUND

• Oxford Grice K, Vogel KA, Le V, Mitchell A, Muniz S, Vollmer MA. Adult norms for a commercially available Nine Hole Peg Test for finger dexterity. Am J Occup Ther. 2003 Sep-Oct;57(5):570-3. doi: 10.5014/ajot.57.5.570.

  PMID: 14527120 BACKGROUND

• Tolle KA, Rahman-Filipiak AM, Hale AC, Kitchen Andren KA, Spencer RJ. Grooved Pegboard Test as a measure of executive functioning. Appl Neuropsychol Adult. 2020 Sep-Oct;27(5):414-420. doi: 10.1080/23279095.2018.1559165. Epub 2019 Feb 8.

  PMID: 30734576 BACKGROUND

• Figueiredo, S.: Box and Block Test (BBT)

  BACKGROUND

• Van de Winckel A, Feys H, van der Knaap S, Messerli R, Baronti F, Lehmann R, Van Hemelrijk B, Pante F, Perfetti C, De Weerdt W. Can quality of movement be measured? Rasch analysis and inter-rater reliability of the Motor Evaluation Scale for Upper Extremity in Stroke Patients (MESUPES). Clin Rehabil. 2006 Oct;20(10):871-84. doi: 10.1177/0269215506072181.

  PMID: 17008339 BACKGROUND

• Sulter G, Steen C, De Keyser J. Use of the Barthel index and modified Rankin scale in acute stroke trials. Stroke. 1999 Aug;30(8):1538-41. doi: 10.1161/01.str.30.8.1538.

  PMID: 10436097 BACKGROUND

• Demers L, Weiss-Lambrou R, Ska B. Item analysis of the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST). Assist Technol. 2000;12(2):96-105. doi: 10.1080/10400435.2000.10132015.

  PMID: 11508406 BACKGROUND

• Barrera, C.A.M. PhD thesis

  BACKGROUND

• R Core Team: R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, Vienna, Austria (2022). R Foundation for Statistical Computing. https://www.R-project.org/

  BACKGROUND

• Barria P, Riquelme M, Reppich H, Cisnal A, Fraile JC, Perez-Turiel J, Sierra D, Aguilar R, Andrade A, Nunez-Espinosa C. Hand rehabilitation based on the RobHand exoskeleton in stroke patients: A case series study. Front Robot AI. 2023 Mar 22;10:1146018. doi: 10.3389/frobt.2023.1146018. eCollection 2023.

  PMID: 37033674 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Asterio H Andrade, PhD

  Rehabilitation Center Club de Leones Cruz del Sur

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 28, 2022
• Study Start: March 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)