NCT05911113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

June 17, 2023

Last Update Submit

February 12, 2024

Conditions

Keywords

post-covid 19 polyneuropathysensory re-education paradigmsensationquality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to six weeks

Secondary Outcomes (3)

  • Tactile sensation

    up to six weeks

  • hand grip strength

    up to six weeks

  • joint position error

    up to six weeks

Study Arms (2)

sensory re-education training

EXPERIMENTAL

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

Other: sensory re-education trainingOther: traditional treatment

traditional treatment

ACTIVE COMPARATOR

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

Other: traditional treatment

Interventions

the patients will receive sensory re-education training in the form of texture discrimination training, limb position sense and tactile object recognition

sensory re-education training

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.

sensory re-education trainingtraditional treatment

Eligibility Criteria

Age30 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelope
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: sensory re-education and traditional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator younes ali khadour

Study Record Dates

First Submitted

June 17, 2023

First Posted

June 20, 2023

Study Start

June 26, 2023

Primary Completion

August 30, 2023

Study Completion

October 30, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations