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NCT Number: NCT04543032

Sensorimotor Training and Gait in Diabetic Polyneuropathy

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University

Giza, 12613, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensorimotor Training

Other

Sensorimotor exercises progressed from stable surfaces to unstable surfaces, training gait in a line (tandem walk or walking straight) followed by gait including change in directions, gait without obstacles to gait with obstacles, change in the support base (feet apart and then together), physical exercises with eyes opened and closed, always respecting the functional capacity of each patient and progressively increasing the difficulty of each exercise. To help the training, cones, balance board, bars, mats and a mini-trampoline will be used. According to the patient progress, the exercises will be combined, generating circuits

Primary outcomes

  1. 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.

  2. 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

  3. 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

Secondary outcomes

  1. Proprioception of ankle joint

    Time frame: 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).

  2. Muscle strength of ankle dorsiflexors and plantar flexors

    Time frame: 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).

  3. Assessment of Quality of life

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 9, 2020
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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