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Completed

NCT Number: NCT05598892

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, 6211525, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training with Robotic Hand Exoskeleton

Device

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.

Primary outcomes

  1. 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.

  2. 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

  1. Nine Hole Peg Test (9-HPT) Baseline

    Time frame: 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.

  2. Nine Hole Peg Test (9-HPT) Post Intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Corporación de Rehabilitación Club de Leones Cruz del Sur

Other

Collaborators

  • Universidad de Magallanes
  • University of Valladolid

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2022
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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