Effect of Spasticity on Tibial Nerve Entrapment

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06092190
• Other study ID #: 2020
• Status: Active, not recruiting
• Start date: March 20, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: October 2023
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Nerve Compression Syndromes
• Neuropathy
• Stroke

Intervention

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

Locations

Country	Name	City	State
Egypt	October 6 University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electrodiagnostic testing	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