Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19

Post-acute Covid-19 Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06137716
• Other study ID #: CASVE-NM-22-575
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: November 2023
• Source: University of Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Physical And Rehabilitation Medicine
• Rehabilitation Outcome

Intervention

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.

Locations

Country	Name	City	State
Spain	Centro Hospitalario Padre Benito Menni	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
University of Valladolid	Centro Hospitalario Padre Benito Menni

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Semi-structured interview	Additional information about personal and environmental factors and participatio	Baseline