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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05598892

Enrollment

Registered

2022-10-28

Start date

2021-03-01

Completion date

2021-09-30

Last updated

2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Hand Rehabilitation, Exoskeleton

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.

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.

Interventions

DEVICETraining 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Dynamometry - Grip Baseline	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.
Dynamometry - Grip Post Intervention	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

Measure	Time frame	Description
Nine Hole Peg Test (9-HPT) Baseline	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.
Nine Hole Peg Test (9-HPT) Post Intervention	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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026