Post-COVID-19 SyndromeCOVIDNCT05911113
Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy
A study testing sensory re-education training and traditional treatment in people with Post-COVID-19 Syndrome, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- sensory re-education training and traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jun 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- sensory re-education training, traditional treatment
- Keywords
- post-covid 19 polyneuropathy, sensory re-education paradigm, sensation, quality of life
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sensory re-education trainingOther
the patients will receive sensory re-education training in the form of texture discrimination training, limb position sense and tactile object recognition
traditional treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| sensory re-education training | Experimental | the patients will receive sensory re-education training three times a week for six weeks Receives: Other: sensory re-education training; Other: traditional treatment |
| traditional treatment | Active comparator | the patients will receive traditional treatment three times a week for six weeks Receives: Other: traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to six weeks
Secondary outcomes (3)
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
Measured: up to six weeks
hand grip strength
The hand-held dynamometer will be used to assess hand grip strength
Measured: up to six weeks
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.
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start26 Jun 2023
- Primary completion30 Aug 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sensory re-education and traditional therapy
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younes Ali Khadour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911113
- Sponsor's protocol ID
- P.T.REC/012/004416
- Acronym
- COVID
- Status last verified
- Feb 2024
- First submitted
- 17 Jun 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alsaid HM, Khadour YA, Zakaria HM, Fahmy EM, Khadour FA, Mamoon RS, Khalil ASA, Ragab WM, Darwesh AA, Ali MG. Impact of Sensory Re-education Paradigm on Quality of Life, Tactile Sensation, and Proprioceptive Acuity in Patients with Post-COVID-19 Polyneuropathy: A Randomized Controlled Trial. J Musculoskelet Neuronal Interact. 2026 Jun 1;26(2):242-251. doi: 10.22540/JMNI-26-242.
PubMed 42220029
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy
- ClinicalTrials.gov ID
- NCT05911113
- Acronym / sponsor ID
- COVID / P.T.REC/012/004416
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- post-covid 19 polyneuropathy, sensory re-education paradigm, sensation, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- sensory re-education and traditional therapy
| Arm | Type | Receives |
|---|---|---|
| sensory re-education training | Experimental | Other: sensory re-education training, Other: traditional treatmentthe patients will receive sensory re-education training three times a week for six weeks |
| traditional treatment | Active comparator | Other: traditional treatmentthe patients will receive traditional treatment three times a week for six weeks |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensory re-education trainingthe patients will receive sensory re-education training in the form of texture discrimination training, limb position sense and tactile object recognition | Other | sensory re-education training |
| traditional treatmentthe 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. | Other | sensory re-education training, traditional treatment |
Primary outcome
disability of life
Time frame: up to six weeks
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.
3 secondary outcomes
Tactile sensation
Time frame: up to six weeks
hand grip strength
Time frame: up to six weeks
joint position error
Time frame: up to six weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 42220029Alsaid HM, Khadour YA, Zakaria HM, Fahmy EM, Khadour FA, Mamoon RS, Khalil ASA, Ragab WM, Darwesh AA, Ali MG. Impact of Sensory Re-education Paradigm on Quality of Life, Tactile Sensation, and Proprioceptive Acuity in Patients with Post-COVID-19 Polyneuropathy: A Randomized Controlled Trial. J Musculoskelet Neuronal Interact. 2026 Jun 1;26(2):242-251. doi: 10.22540/JMNI-26-242.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensory re-education training and traditional treatment in people with Post-COVID-19 Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disability of life (time frame: up to six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05911113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.