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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05598892
Recruitment Status : Completed
First Posted : October 28, 2022
Last Update Posted : October 28, 2022
Sponsor:
Collaborators:
University of Valladolid
Universidad de Magallanes
Information provided by (Responsible Party):
Corporación de Rehabilitación Club de Leones Cruz del Sur

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Device: Training with Robotic Hand Exoskeleton Not Applicable

Detailed Description:
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. The study was carried out by the Neurotchnology Group of the Research and Development Area of the Corporación de Rehabilitación Club de Leones Cruz del Sur, Chile. Clinical test were implemented on four subjects with Stroke sequelae who participated in two evaluations of manual function and 16 training sessions with the robotic exoskeleton, in order to know the clinical effects on manual function, safety and satisfaction of users who utilize the exoskeleton RobHand.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study
Actual Study Start Date : March 1, 2021
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Robot-assisted Rehabilitation
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Dynamometry - Grip Baseline [ Time Frame: 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.

  2. Dynamometry - Grip Post Intervention [ Time Frame: 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Nine Hole Peg Test (9-HPT) Baseline [ Time Frame: Baseline ]
    9-HPT seeks to evaluate the dexterity of the fingers [43], for which a board and nine pegs are used. The patient must place the 9 pegs on the board and then remove all of them, using the dominant and non-dominant hand. This test is timed.

  2. Nine Hole Peg Test (9-HPT) Post Intervention [ Time Frame: 8 weeks ]
    9-HPT seeks to evaluate the dexterity of the fingers [43], for which a board and nine pegs are used. The patient must place the 9 pegs on the board and then remove all of them, using the dominant and non-dominant hand. This test is timed.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Comorbidities in the central nervous system
  • Pain in the upper extremity (hand, forearm, arm)
  • Patient who does not sign the informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05598892


Locations
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Chile
Corporación de Rehabilitación Club de Leones Cruz del Sur
Punta Arenas, XII Región, Chile, 6211525
Sponsors and Collaborators
Corporación de Rehabilitación Club de Leones Cruz del Sur
University of Valladolid
Universidad de Magallanes
Investigators
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Study Chair: Asterio H Andrade, PhD Rehabilitation Center Club de Leones Cruz del Sur
More Information
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Publications:
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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)
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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
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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).
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/
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)
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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
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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
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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
Figueiredo, S.: Box and Block Test (BBT)
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Responsible Party: Corporación de Rehabilitación Club de Leones Cruz del Sur
ClinicalTrials.gov Identifier: NCT05598892    
Other Study ID Numbers: CorporacionRCLCS0008
First Posted: October 28, 2022    Key Record Dates
Last Update Posted: October 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corporación de Rehabilitación Club de Leones Cruz del Sur:
Stroke
Hand Rehabilitation
Exoskeleton
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases