Diabetic Peripheral Neuropathy
Conditions
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.
Interventions
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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 |
Countries
Egypt
Outcome results
None listed