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Clinical Trial 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).


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05457192
Study type Observational
Source Cairo University
Contact Hamada Ahmed Hamada, Assistant professor
Phone 01117893697
Email hamada.ahmed@pt.cu.edu.eg
Status Recruiting
Phase
Start date July 2022
Completion date October 2022

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