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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Training with Robotic Hand Exoskeleton

• Registration Number: NCT05598892
• Lead Sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-27
• Study First Submitted QC: 2022-10-27
• Last Update Submitted: 2022-10-27
• Study First Posted: 2022-10-28
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot-assisted Rehabilitation	Training with Robotic Hand Exoskeleton	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur; 🇨🇱 Punta Arenas, XII Región, Chile