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

Sponsor
Corporación de Rehabilitación Club de Leones Cruz del Sur (Other)
Overall Status
Completed
CT.gov ID
NCT05598892
Collaborator
University of Valladolid (Other), Universidad de Magallanes (Other)
4
1
1
7
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Training with Robotic Hand Exoskeleton
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Hand Rehabilitation Based on a RobHand Exoskeleton in Stroke Patients: a Case Series Study
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Robot-assisted Rehabilitation

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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Corporación de Rehabilitación Club de Leones Cruz del Sur Punta Arenas XII Región Chile 6211525

Sponsors and Collaborators

  • Corporación de Rehabilitación Club de Leones Cruz del Sur
  • University of Valladolid
  • Universidad de Magallanes

Investigators

  • Study Chair: Asterio H Andrade, PhD, Rehabilitation Center Club de Leones Cruz del Sur

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Corporación de Rehabilitación Club de Leones Cruz del Sur
ClinicalTrials.gov Identifier:
NCT05598892
Other Study ID Numbers:
  • CorporacionRCLCS0008
First Posted:
Oct 28, 2022
Last Update Posted:
Oct 28, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Corporación de Rehabilitación Club de Leones Cruz del Sur
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2022