Correlation of HbA1c With Electrophysiological Studies and Gait Performance in Diabetic Polyneuropathy Patients

NCT ID: NCT05457192

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2022-10-31

Brief Summary

This study will be conducted to investigate the relationship between glycosylated hemoglobin (HbA1c) and nerve conduction studies (NCS) with gait performance in patients with DPN. 65 patients with type II DM with moderate polyneuropathy will participate in this study. Glycosylated Hemoglobin (HbA1c) test will be done for each patient by using the Colorimeter device. Nerve conduction studies (NCS) will be performed for each patient by using the electromyography device to confirm the diagnosis of DPN. The neurophysiological functions of peripheral nerves including (The Common peroneal, Tibial, Sural, and Ulnar motor & sensory branches) will be measured. Spatiotemporal gait parameters (stride length, cadence& velocity) for all the patients will be assessed by two-dimension video-based motion analysis (2D).

Detailed Description

The current study is to investigate the correlation between glycosylated haemoglobin (HbA1c) with nerve conduction studies (NCS) including amplitudes, conduction velocities &latency with spatiotemporal gait parameters including stride length, cadence& velocity in patients with diabetic polyneuropathy (DPN). The patients will be recruited from the Out- patient clinic of Faculty of Physical Therapy, Cairo University. All the patients suffering from moderate polyneuropathy according to Toronto Clinical Neuropathy Scoring System (TCSS), and Neuropathy Impairment Score in the lower limbs (NIS-LL). Glycosylated Hemoglobin (HbA1c) test will be done for each patient by using the Colorimeter device. Blood will be collected in a EDTA (3 cm) tube that's attached to the needle. A nerve conduction study will be performed for each patient. Five nerves will be examined in this study including (The common peroneal, tibial, sural and ulnar motor & sensory branches). The Nerve conduction studies involve analysis of specific parameters including amplitude (mv), latency (msec.) and conduction velocity(m/s). The evaluation procedure will be explained to each patient before starting examination. Gait parameters including (stride length, cadence & velocity) will be assessed using 2D video-based motion analysis. The gait will be captured by a digital video camera; (Canon 10 mega pixel - 4x optical zoom, lens 4x15/6.2-24.8mm1:2.7-5.6). The resultant captured film will then be processed using a special software computer program (Adobe premier ver. 6.0).

Conditions

Diabetic Polyneuropathy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Moderate diabetic polyneuropathy (DPN)

65 patients of both sexes (males \& females) with type II DM with moderate polyneuropathy will be included. Patients will be enrolled and assessed for their eligibility to participate in this study. Their body mass index (BMI) will range from 20:30 kg/m2, age will range from 40-60 years, postprandial blood sugar more than 200 mg/dl, duration of diabetic illness five years ago or more and serum Hb1AC will be between 7% and 14%. All the patients suffering from moderate polyneuropathy according to Toronto Clinical Neuropathy Scoring System (TCSS) (score nine to 11 points), and Neuropathy Impairment Score in the lower limbs (NIS-LL) (The muscle power of the lower limbs will be more than grade 2 and less than grade 4)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• The diagnosis will be confirmed by Nerve Conduction Studies "NCS".
• All the patients suffering from moderate polyneuropathy according to Toronto Clinical Neuropathy Scoring System (TCSS) and Neuropathy Impairment Score (NIS-LL).
• Body mass index (BMI) will range from 20:30 kg/m2.
• Age will range from 40-60 years.
• Postprandial blood sugar more than 200 mg/dl.
• Duration of diabetic illness five years ago or more and serum Hb1AC will be between 7% and 14%.
• Able to walk independently with or without walking aids.

Exclusion Criteria

• Patients with type I DM.
• History of myopathy or neuromuscular diseases.
• Pregnant females.
• Alcoholics.
• History of major cardiac diseases, heavy metal.
• Other neurological problems as stroke.
• History of ulcers in the lower limbs, foot deformities or malunion fracture of the lower limbs, and acute nerve root compression or advanced arthritis affecting lower extremity.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shereen Saad Eldin Mohamed Ali

OTHER

Sponsor Role: lead

Responsible Party

Shereen Saad Eldin Mohamed Ali

Lecturer of physical therapy for Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shereen Saad Eldin Mohamed, Lecturer

Role: PRINCIPAL_INVESTIGATOR

lecturer of Neurology at faculty of physical therapy-Cairo university

Locations

Faculty of physical therapy-Cairo University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hamada Ahmed Hamada, Assistant professor

Role: CONTACT

hamada.ahmed@pt.cu.edu.eg

01117893697 ext. 002

Facility Contacts

Hamada Ahmed Hamada, assistant professor

Role: primary

hamada.ahmed@pt.cu.edu.eg

01117893697 ext. 002

Other Identifiers

P.T.REC/012/003777

Identifier Type: -

Identifier Source: org_study_id