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Clinical Trials/NCT05598892
NCT05598892
Completed
Not Applicable

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

Corporación de Rehabilitación Club de Leones Cruz del Sur1 site in 1 country4 target enrollmentMarch 1, 2021
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Enrollment
4
Locations
1
Primary Endpoint
Dynamometry - Grip Baseline
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
September 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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.

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 Outcomes

  • Nine Hole Peg Test (9-HPT) Post Intervention(8 weeks)
  • Nine Hole Peg Test (9-HPT) Baseline(Baseline)

Study Sites (1)

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