NCT06092190

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 20, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 14, 2023

Last Update Submit

October 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group A

Device: EMG

Group B

Device: EMG

Interventions

EMGDEVICE

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 AGroup B

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Cairo, 11742, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hosam Magdy Metwally Abd Alhamid, Ph.D

    October 6 University

    PRINCIPAL INVESTIGATOR
  • Ahmed Magdy Alshimy, Ph.D

    Al Ryada University for science and technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy for neurology

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 23, 2023

Study Start

March 20, 2023

Primary Completion

June 20, 2023

Study Completion

October 20, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations