Effect of Spasticity on Tibial Nerve Entrapment

October 14, 2023 updated by: Hosam Magdy Metwally, October 6 University

Impact of Lower Limb Spasticity on Tibial Nerve Entrapment in Patients With Stroke

Stroke is the most common cause of mortality and is one of the most common causes of morbidity in the world. Polyneuropathies and entrapment neuropathies are known as the complications of stroke

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11742
        • October 6 University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

A hundred patients were selected from the Out-Patient Clinics of Neurology in Kasr Al- Aini Hospitals and Out-Patient Clinic of Neurology, Faculty of Physical Therapy, Cairo University.

Description

Inclusion Criteria:

  • 1- A hundred patients with hemiplegia /paresis subsequent to a stroke as diagnosed by CT or MRI.

    2- A hundred patients from both sexes, their ages ranged from (55-65) years. 3- Body weight of patients was ranged from(55 -95 kg) ,while their height was from (151-185 cm) and BMI was ranged from (20-30 kg/m2).

    4- Duration of illness (6 - 9 months post stroke). 5- Patients have spasticity ranging from grade 1 to grade 3 according to modified Ashworth scale 6- Patients were medically stable

Exclusion Criteria:

  • 1- Patients with lumbosacral sciatica that could mimic TTS or interfere with its evaluation 2- Patients with tibial neuropathy, significant polyneuropathy, or marked orthopedic abnormalities; 3- Patients with contractures 4- Patients with psychological disturbance or seizures 5- Systemic diseases known to cause TTS, such as diabetes mellitus, hypothyroidism, rheumatoid arthritis, or chronic renal failure;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Device: EMG
Electrodiagnostic testing (electromyography and nerve conduction velocity) can objectively verify the tibial nerve dysfunction. Electrodiagnosis rests upon demonstrating impaired tibial nerve conduction across the tarsal tunnel in context of normal conduction
Group B
Device: EMG
Electrodiagnostic testing (electromyography and nerve conduction velocity) can objectively verify the tibial nerve dysfunction. Electrodiagnosis rests upon demonstrating impaired tibial nerve conduction across the tarsal tunnel in context of normal conduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrodiagnostic testing
Time Frame: 30 minutes
Electrodiagnostic testing (electromyography and nerve conduction velocity) can objectively verify the tibial nerve dysfunction. Electrodiagnosis rests upon demonstrating impaired tibial nerve conduction across the tarsal tunnel in context of normal conduction. Compression results in damage to the myelin sheath and manifests as delayed latencies and slowed conduction velocities
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Investigators

  • Principal Investigator: Hosam Magdy Metwally Abd Alhamid, Ph.D, October 6 University
  • Principal Investigator: Ahmed Magdy Alshimy, Ph.D, Al Ryada University for science and technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Actual)

June 20, 2023

Study Completion (Estimated)

October 20, 2023

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

October 14, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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