Sensorimotor Training and Gait in Diabetic Polyneuropathy

NCT04543032 | Completed

• 1 other identifier: SMT for polyneuropathy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• Measurement of walking speed

  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.

  change from baseline at six weeks

• Measurement of step length

  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

  change from baseline at six weeks

• Measurement of stride length

  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

  change from baseline at six weeks

Secondary Outcomes (3)

• Proprioception of ankle joint

  change from baseline at six weeks

• Muscle strength of ankle dorsiflexors and plantar flexors

  change from baseline at six weeks

• Assessment of Quality of life

  change from baseline at six weeks

Study Arms (2)

study group

EXPERIMENTAL

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

Other: sensorimotor training

control group

NO INTERVENTION

the patients in this group will receive medical care only.

Interventions

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

study group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 %) .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, 12613, Egypt

Location

Related Publications (4)

• 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.

  PMID: 26729347 BACKGROUND

• 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.

  PMID: 30428863 BACKGROUND

• Mizukami H. [Pathophysiology of diabetic polyneuropathy]. Nihon Rinsho. 2016 Apr;74 Suppl 2:229-33. No abstract available. Japanese.

  PMID: 27266093 BACKGROUND

• Saleh MSM, Elbanna RHM, Abdelhakiem NM, Abdalla GAE. Sensorimotor Training Improves Gait, Ankle Joint Proprioception, and Quality of Life in Patients With Diabetic Peripheral Neuropathy: A Single-Blinded Randomized Controlled Trial. Am J Phys Med Rehabil. 2024 Jul 1;103(7):638-644. doi: 10.1097/PHM.0000000000002453. Epub 2024 Feb 29.

  PMID: 38466203 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistance professor doctor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 9, 2020
• Study Start: January 5, 2021
• Primary Completion: May 20, 2021
• Study Completion: March 7, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

EG (1)