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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Device: Training with Robotic Hand Exoskeleton


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted Rehabilitation<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nine Hole Peg Test (9-HPT) 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. | Baseline | 
| Nine Hole Peg Test (9-HPT) Post Intervention | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Hand Rehabilitation, Exoskeleton