- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911113
Impact Of Sensory Re-Education Paradigm On Sensation And Quality Of Life In Patients Post-Covid 19 Polyneuropathy (COVID)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Faculty of physical therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sensory re-education training
the patients will receive sensory re-education training three times a week for six weeks
|
the patients will receive sensory re-education training in the form of texture discrimination training, limb position sense and tactile object recognition
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.
|
Active Comparator: traditional treatment
the patients will receive traditional treatment three times a week for six weeks
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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up to six weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tactile sensation
Time Frame: up to six weeks
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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
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up to six weeks
|
hand grip strength
Time Frame: up to six weeks
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The hand-held dynamometer will be used to assess hand grip strength
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up to six weeks
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joint position error
Time Frame: up to six weeks
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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.
|
up to six weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- COVID-19
- Polyneuropathies
Other Study ID Numbers
- P.T.REC/012/004416
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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