Effect of Spasticity on Tibial Nerve Entrapment

Sponsor

October 6 University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06092190

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neuropathy Stroke	Device: EMG

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Crossover

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 20, 2023

Actual Primary Completion Date :

Jun 20, 2023

Anticipated Study Completion Date :

Oct 20, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Electrodiagnostic testing [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 University	Cairo		Egypt	11742

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hosam Magdy Metwally, Lecturer of physical therapy for neurology, October 6 University

ClinicalTrials.gov Identifier:

NCT06092190

Other Study ID Numbers:

2020

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nerve Compression Syndromes

Study Results

No Results Posted as of Oct 23, 2023