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Sensorimotor Training and Gait in Diabetic Polyneuropathy

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Diabetic Peripheral Neuropathy

Treatments

Other: sensorimotor training

Study type

Interventional

Funder types

Other

Identifiers

NCT04543032
SMT for polyneuropathy

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

50 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

study group
Experimental group
Description:
the patients in this group will receive sensorimotor training for 6 weeks in addition to medical care.
Treatment:
Other: sensorimotor training
control group
No Intervention group
Description:
the patients in this group will receive medical care only.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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