Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19

Development and Clinical Trials of a Rehabilitation Platform to Accelerate the Recovery of Patients With COVID Neuromotor Sequelae

Prolonged hospitalization in severe COVID-19 cases can lead to substantial muscle loss and functional deterioration. While rehabilitation is vital, conventional approaches encounter capacity constraints. Therefore, assessing the efficacy of robotic-assisted rehabilitation is crucial for post-COVID-19 fatigue syndrome patients, aiming to improve motor function and overall recovery. The study focuses on evaluating rehabilitation effectiveness in individuals with upper-extremity impairment using a hand exoskeleton-based robotic system.

Study Overview

• Status: Completed
• Conditions: Post-acute Covid-19 Syndrome; Rehabilitation Outcome; Robotic Exoskeleton; Physical And Rehabilitation Medicine
• Intervention / Treatment: Device: Training with a Robotic Hand Exoskeleton

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47008
    • Centro Hospitalario Padre Benito Menni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 30 years old
• Patients infected with COVID-19 and has received care at the Centro Hospitalario Benito Menni
• Patients with acute or limited functional or strength impairment in at least one of the upper extremities
• Patients who would complete a rehabilitation program and a series of patient reported outcome questionnaires and a follow up evaluation
• Patients who give inform written consent.

Exclusion Criteria:

• Presence of behavioral disorders
• Dementia (loss of memory of cognitive functions)
• Disorders of consciousness (confusional states and drowsiness)
• Uncontrolled or severely limiting delusions and hallucinations
• Infectious skin diseases
• Rrisk of epileptic seizures due to COVID itself or prior to it
• Severe visual impairments
• Severe spasticity with a Modified Ashworth Scale >2, joint stiffness in the wrist and fingers
• Pain with a score >8 on the Visual Analog Scale (VAS) during mobilization of the affected hand.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participant Group/Arm; Participants will rehabilitation with a robotic hand exoskeleton.

Device: Training with a Robotic Hand Exoskeleton; The rehabilitation program extended over six consecutive weeks. Each therapy session, lasting 45 minutes, occurred four times per week, resulting in a total of 24 sessions. Within each session, a total of six exercises, consisting of three passive exercises and three bilateral exercises, were performed in an alternating manner. The exercises were executed in the following sequence: 1) Bilateral hand opening and closing; 2) Passive independent finger opening and closing; 3) Bilateral pinch; 4) Passive hand opening and closing; 5) Bilateral hand opening and closing based on a VR-based game involving squeezing an orange; 6) Passive pinch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel Index (BI)	The Barthel Index (BI) modified by Granger et al is an ordinal scale for measuring the ability of an individual to independently execute 15 activities of daily living (ADL) related with mobility and self-care. BI aims to evaluate the degree of independence, with a final score ranging from 0 to 100, where 0 indicates full dependence.	Baseline / 6 weeks
Functional Independence Measure (MIF)	The Functional Independence Measure (MIF) was designed to provide an indicator of disability independent of a patient's impairment. The scale consists of 18 items to evaluate functional abilities in the area of communication, locomotion, self-care, social cognition, sphincter control and transfers. Each of these items is quantified utilizing a 7-point Likert scale. The total score, obtained by summing the individual item scores, spans from 18 to 126, with 18 denoting a state of complete dependence	Baseline / 6 weeks
SF-36 Health Questionnaire	The SF-36 Health Questionnaire consists of 36 items designed to assess health-related quality of live. It encompasses eight scales, each comprising 2 to 10 items, which aimed to evaluate various health attributes. These scales include physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health.The score of each scale ranges from 0 to 100, with higher scores indicating a better health-related quality of life.	Baseline / 6 weeks
Range of motion	The range of motion was analyzed by goniometry measurements using the HandTutor® glove. It provides the active and passive movement of the participants fingers through sensors located in the front and back of the glove.	Baseline / 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semi-structured interview	Additional information about personal and environmental factors and participatio	Baseline

Collaborators and Investigators

• Sponsor: University of Valladolid
• Collaborators: Centro Hospitalario Padre Benito Menni

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Estimated): November 17, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: CASVE-NM-22-575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No