Sensorimotor Training and Gait in Diabetic Polyneuropathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2022-03-07

Brief Summary

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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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Detailed Description

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Conditions

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Diabetic Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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study group

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

Group Type EXPERIMENTAL

sensorimotor training

Intervention Type 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

control group

the patients in this group will receive medical care only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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sensorimotor training

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No