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Completed

NCT Number: NCT06137716

Robotic Assisted Hand Rehabilitation Outcomes in Adults After COVID-19

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.

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Key information

Conditions

Robotic Exoskeleton COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Physical and Rehabilitation Medicine Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Rehabilitation Outcome Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalario Padre Benito Menni

Valladolid, 47008, Spain

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Training with a Robotic Hand Exoskeleton

Device

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.

Primary outcomes

  1. Barthel Index (BI)

    Time frame: Baseline / 6 weeks

    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.

  2. Functional Independence Measure (MIF)

    Time frame: Baseline / 6 weeks

    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

  3. SF-36 Health Questionnaire

    Time frame: Baseline / 6 weeks

    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.

  4. Range of motion

    Time frame: Baseline / 6 weeks

    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.

Secondary outcomes

  1. Semi-structured interview

    Time frame: Baseline

    Additional information about personal and environmental factors and participatio

Sponsors and collaborators

Lead sponsor

University of Valladolid

Other

Collaborators

  • Centro Hospitalario Padre Benito Menni

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

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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