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Clinical Trials/NCT04543032
NCT04543032
Completed
N/A

Effect of Sensorimotor Training on Gait, Ankle Muscle Strength and Quality of Life in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial

Cairo University1 site in 1 country40 target enrollmentJanuary 5, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetic Peripheral Neuropathy
Sponsor
Cairo University
Enrollment
40
Locations
1
Primary Endpoint
Measurement of stride length
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Diabetic peripheral neuropathy is a common chronic complication of diabetes mellitus which results in high public health costs and has a huge impact on patients' quality of life. It leads to sensory and motor deficits, which often result in mobility-related dysfunction, and alterations in gait characteristics. These alternations in gait performance cause increase in the risk of fall, which has the strongest association with symptoms of depression in patients with diabetes. However, little is known about possible treatment strategies for improving gait ability and reduce risk of fall in patients with diabetic neuropathy. So, the purpose of this study will be to investigate the effect of sensorimotor training on ankle muscle strength, gait and quality of life in patients with diabetic peripheral neuropathy.

To determine if there is an effect for sensorimotor training on gait, ankle muscle strength and quality of life in patients with diabetic peripheral neuropathy, the patient will be assessed before and after 6 weeks of treatment by measurement of ankle muscles strength using isokinetic dynamometer, measurement of different spatiotemporal gait parameters using gait trainer instrument , and assessment of quality of life of the patients using HRQL questionnaire (SF-36) before and after the treatment sessions.

Registry
clinicaltrials.gov
Start Date
January 5, 2021
End Date
March 7, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Shafiek Mustafa Saleh

assistance professor doctor

Cairo University

Eligibility Criteria

Inclusion Criteria

  • patient who have body mass index did not exceed 30 Kg/m
  • type II diabetes mellitus diagnosed for at least 7 years.
  • able to walk without assistance or assistive device
  • able to stand on both feet and on one leg
  • have controlled blood glucose level by the screening by Glycated Haemoglobin test (9 % \> HbA1c \> 6.5 %) .

Exclusion Criteria

  • The patients will be excluded if they have:
  • cognitive deficits, severe retinopathy, scares under their feet, hypo or hypertension, any medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, other neurological or orthopaedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis), and severe nephropathy that causes edema or needs haemodialysis.

Outcomes

Primary Outcomes

Measurement of stride length

Time Frame: change from baseline at six weeks

Stride length is one of distance variables for measurement of kinematic gait analysis. It is the linear distance from the posterior aspect of the heel of one foot to the posterior aspect of the heel of the same foot and measured by (meter) It will be measured using the Biodex Gait Trainer

Measurement of step length

Time Frame: change from baseline at six weeks

Step length is one of distance variables for measurement of kinematic gait analysis. It is the linear distance from the posterior aspect of the heel of one foot to the posterior aspect of the heel of the opposite foot and measured by (meter) It will be measured using the Biodex Gait Trainer

Measurement of walking speed

Time Frame: change from baseline at six weeks

Speed of walking is one of time variables for measurement of kinematic gait analysis. It measured by (meter/second). It will be measured using the Biodex Gait Trainer: It is a device designed specifically for assessment, rehabilitation and retraining of gait for all patients, which composed of a treadmill with an instrumented deck that monitors and records kinematic gait parameters with a high resolution color touch screen (Liquid-Crystal Display) attached to the treadmill to control the device settings and display results.

Secondary Outcomes

  • Proprioception of ankle joint(change from baseline at six weeks)
  • Assessment of Quality of life(change from baseline at six weeks)
  • Muscle strength of ankle dorsiflexors and plantar flexors(change from baseline at six weeks)

Study Sites (1)

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