search
Back to results

Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy (COVID)

Primary Purpose

Post-COVID-19 Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sensory re-education training
traditional treatment
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome focused on measuring post-covid 19 polyneuropathy, sensory re-education paradigm, sensation, quality of life

Eligibility Criteria

30 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients from both genders (male and female). The age of participants ranged from 30 to 40 years old. Participants were required to live in Egypt during the pre-covid and COVID-19 pandemic. Patients with confirmation of previous covid19 infection PCR TEST. Patients meeting the guide line of world health organization (WHO) of long/post-covid 19 syndromes. Patients with unknown prior neuropathy. Patients with neuropathy confirmed by EDX with a sensory nerve conduction velocity. Exclusion Criteria: Patients with Diabetes mellitus (DM), Rheumatology and Guillain-Barré syndrome (GBS). Infection other than covid19 leading to sensory neuropathy. Traumatic or compressive lesions leading to central nervous system (CNS), peripheral nervous system (PNS) damages. Previous surgeries or medications leading to neuropathy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    sensory re-education training

    traditional treatment

    Arm Description

    the patients will receive sensory re-education training three times a week for six weeks

    the patients will receive traditional treatment three times a week for six weeks

    Outcomes

    Primary Outcome Measures

    disability of life
    disability of life will be measured using the Arabic, validated version of WHOQOL-BREF questionnaire. The scale consists of 26 items; the first two items address an individual's perception of his/her overall quality of life and health, respectively, and the remaining 24 items assess the four quality of life domains; Physical Health (seven items), Psychological (six items), Social Relationships (three items), and Environment (eight items). Each item is rated on a five-point Likert scale. The final scores were converted into a linear scale between 0 and 100 according to the scoring guidelines where higher scores indicate higher disability.

    Secondary Outcome Measures

    Tactile sensation
    The Semmes Weinstein Monofilament (SWM) tool will be used to assess cutaneous sensibility threshold. This is to assess touch detection thresholds of the hand and fingers. The short version (pocket filaments) with five filaments from 0.07 to 300 g was used. The touch detection thresholds were scored on a 0 to 5-point scale, where 5 represents the thinnest filament and 0 represents the largest filament. Three different positions of the hand were tested: the fingertip of fingers, proximal phalanx of fingers, and palm of the hand yielding a total sum score of 15 points
    hand grip strength
    The hand-held dynamometer will be used to assess hand grip strength
    joint position error
    The laser-pointer assisted angle reproduction test will be used to assess the joint position error of wrist joint.The test person will be sitting on a hand-rested chair the wrist will be free out of the hand-rest of the chair, the chair is seated at a marked line on the floor that being drawn parallelly and in one-meter distance to a target board fixed on the opposite wall. A pointing laser will be fixed at the dorsum of the hand. The test person will be asked to raise their affected wrist from neutral position to aim for assigned points at 10°, 30° and 45°. The neutral position is defined as arbitrary zero. Values at a positive angels represent flexion angels. The negative angels will represent extension angels. The patient is required to memorize the different joint positions. In the next step, the patient's eyes were covered to inhibit visual control. Then they were asked to reproduce the same joint positions as before in a randomized order.

    Full Information

    First Posted
    June 17, 2023
    Last Updated
    June 17, 2023
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05911113
    Brief Title
    Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy
    Acronym
    COVID
    Official Title
    Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 26, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2023 (Anticipated)
    Study Completion Date
    August 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study will be conducted to investigate the effect of a sensory re-education paradigm on sensation and proprioception in patients with post covid-19 neuropathy.
    Detailed Description
    The Coronavirus disease has profoundly impacted the world, altering the functioning of the population and health system. it is so far affected more than 532 million cases and 6.3 million confirmed deaths (WHO., 2020). Recent studies documented that COVID-19-associated peripheral neuropathy is a common and frequent problem, with neuro-muscular complications. This phenomenon is widespread in those with comorbidities, such as diabetes mellitus, which may result from immune processes or as side effects of some medications used to manage COVID-19 symptoms, such as hydroxychloroquine, clindamycin, and steroids. To a lesser extent, prolonged hospitalization may cause entrapment neuropathy (peripheral nerve compression). Most physiotherapists focus on motor improvements rather than sensibility improvements though the sensory system may have the upper hand in improving motor function. Therefore; the sensory re-education paradigm should be assessed in randomized trials with a blinded assessment of functional outcomes to evaluate its effectiveness in patients with post covid-19 neuropathic patients. Currently, there is not enough research addressing the impact of the sensory re-education paradigm on sensation and quality of life in neuropathic patients post-covid19. forty patients will be assigned randomly into two equal groups; the study group will receive sensory re-education paradigm and traditional treatment while the control group will receive traditional treatment only.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-COVID-19 Syndrome
    Keywords
    post-covid 19 polyneuropathy, sensory re-education paradigm, sensation, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    sensory re-education and traditional therapy
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    opaque sealed envelope
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sensory re-education training
    Arm Type
    Experimental
    Arm Description
    the patients will receive sensory re-education training three times a week for six weeks
    Arm Title
    traditional treatment
    Arm Type
    Active Comparator
    Arm Description
    the patients will receive traditional treatment three times a week for six weeks
    Intervention Type
    Other
    Intervention Name(s)
    sensory re-education training
    Intervention Description
    the patients will receive sensory re-education training in the form of texture discrimination training, limb position sense and tactile object recognition
    Intervention Type
    Other
    Intervention Name(s)
    traditional treatment
    Intervention Description
    the Patients in this group will receive traditional treatment in the form of proprioception neuromuscular facilitation (PNF) and graduated active and resisted wrist and hand muscle strengthening exercises.
    Primary Outcome Measure Information:
    Title
    disability of life
    Description
    disability of life will be measured using the Arabic, validated version of WHOQOL-BREF questionnaire. The scale consists of 26 items; the first two items address an individual's perception of his/her overall quality of life and health, respectively, and the remaining 24 items assess the four quality of life domains; Physical Health (seven items), Psychological (six items), Social Relationships (three items), and Environment (eight items). Each item is rated on a five-point Likert scale. The final scores were converted into a linear scale between 0 and 100 according to the scoring guidelines where higher scores indicate higher disability.
    Time Frame
    up to six weeks
    Secondary Outcome Measure Information:
    Title
    Tactile sensation
    Description
    The Semmes Weinstein Monofilament (SWM) tool will be used to assess cutaneous sensibility threshold. This is to assess touch detection thresholds of the hand and fingers. The short version (pocket filaments) with five filaments from 0.07 to 300 g was used. The touch detection thresholds were scored on a 0 to 5-point scale, where 5 represents the thinnest filament and 0 represents the largest filament. Three different positions of the hand were tested: the fingertip of fingers, proximal phalanx of fingers, and palm of the hand yielding a total sum score of 15 points
    Time Frame
    up to six weeks
    Title
    hand grip strength
    Description
    The hand-held dynamometer will be used to assess hand grip strength
    Time Frame
    up to six weeks
    Title
    joint position error
    Description
    The laser-pointer assisted angle reproduction test will be used to assess the joint position error of wrist joint.The test person will be sitting on a hand-rested chair the wrist will be free out of the hand-rest of the chair, the chair is seated at a marked line on the floor that being drawn parallelly and in one-meter distance to a target board fixed on the opposite wall. A pointing laser will be fixed at the dorsum of the hand. The test person will be asked to raise their affected wrist from neutral position to aim for assigned points at 10°, 30° and 45°. The neutral position is defined as arbitrary zero. Values at a positive angels represent flexion angels. The negative angels will represent extension angels. The patient is required to memorize the different joint positions. In the next step, the patient's eyes were covered to inhibit visual control. Then they were asked to reproduce the same joint positions as before in a randomized order.
    Time Frame
    up to six weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients from both genders (male and female). The age of participants ranged from 30 to 40 years old. Participants were required to live in Egypt during the pre-covid and COVID-19 pandemic. Patients with confirmation of previous covid19 infection PCR TEST. Patients meeting the guide line of world health organization (WHO) of long/post-covid 19 syndromes. Patients with unknown prior neuropathy. Patients with neuropathy confirmed by EDX with a sensory nerve conduction velocity. Exclusion Criteria: Patients with Diabetes mellitus (DM), Rheumatology and Guillain-Barré syndrome (GBS). Infection other than covid19 leading to sensory neuropathy. Traumatic or compressive lesions leading to central nervous system (CNS), peripheral nervous system (PNS) damages. Previous surgeries or medications leading to neuropathy.

    12. IPD Sharing Statement

    Learn more about this trial

    Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy

    We'll reach out to this number within 24 hrs