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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05598892
• Other study ID #: CorporacionRCLCS0008
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: September 2022
• Source: Corporación de Rehabilitación Club de Leones Cruz del Sur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Chile	Corporación de Rehabilitación Club de Leones Cruz del Sur	Punta Arenas	XII Región

Sponsors (3)

Lead Sponsor	Collaborator
Corporación de Rehabilitación Club de Leones Cruz del Sur	Universidad de Magallanes, University of Valladolid

Country where clinical trial is conducted

Chile, 

References & Publications (50)

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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