Clinical trial NCT04543032: Sensorimotor Training and Gait in Diabetic Polyneuropathy
Official title: Effect of Sensorimotor Training on Gait, Ankle Muscle Strength and Quality of Life in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of walking speed
timeFrame: change from baseline at six weeks
measure: Measurement of step length
timeFrame: change from baseline at six weeks
measure: Measurement of stride length
timeFrame: change from baseline at six weeks
Secondary outcomes:
measure: Proprioception of ankle joint
timeFrame: change from baseline at six weeks
measure: Muscle strength of ankle dorsiflexors and plantar flexors
timeFrame: change from baseline at six weeks
measure: Assessment of Quality of life
timeFrame: change from baseline at six weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
Study officials:
References:
citation: Mkandla K, Myezwa H, Musenge E. The effects of progressive-resisted exercises on muscle strength and health-related quality of life in persons with HIV-related poly-neuropathy in Zimbabwe. AIDS Care. 2016;28(5):639-43. doi: 10.1080/09540121.2015.1125418. Epub 2016 Jan 5.
citation: Monteiro RL, Sartor CD, Ferreira JSSP, Dantas MGB, Bus SA, Sacco ICN. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2018 Nov 14;19(1):400. doi: 10.1186/s12891-018-2323-0.
citation: Mizukami H. [Pathophysiology of diabetic polyneuropathy]. Nihon Rinsho. 2016 Apr;74 Suppl 2:229-33. No abstract available. Japanese.