Sensorimotor Training and Gait in Diabetic Polyneuropathy

Not Applicable

Completed

• Conditions: Diabetic Peripheral Neuropathy
• Interventions: Other: sensorimotor training

• Registration Number: NCT04543032
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2021-01-05
• Primary Completion: 2021-05-20
• Study Completion: 2022-03-07
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patient who have body mass index did not exceed 30 Kg/m2.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	sensorimotor training	the patients in this group will receive sensorimotor training for 6 weeks in addition to medical care.

Primary Outcome Measures

Name	Time	Method
Measurement of stride length	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	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	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 Outcome Measures

Name	Time	Method
Proprioception of ankle joint	change from baseline at six weeks	proprioception of ankle joint will be measured by Biodex Isokinetic dynamometer system (Biodex Medical Incorporated., Shirley, New York, USA).
Assessment of Quality of life	change from baseline at six weeks	Quality of life will be measured by the Short-Form Health Survey (SF-36) questionnaire.; The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale.; The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.; The eight sections are: * vitality; * physical functioning; * bodily pain; * general health perceptions; * physical role functioning; * emotional role functioning; * social role functioning; * mental health
Muscle strength of ankle dorsiflexors and plantar flexors	change from baseline at six weeks	The strength of the dorsiflexors and plantar flexors muscles of the ankle will be measured by Biodex Isokinetic dynamometer system (Biodex Medical Incorporated., Shirley, New York, USA).

Trial Locations

Locations (1)

Faculty of Physical Therapy, Cairo University; 🇪🇬 Giza, Egypt