Sensorimotor Training and Gait in Diabetic Polyneuropathy
Primary Purpose
Diabetic Peripheral Neuropathy
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sensorimotor training
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy
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.
Sites / Locations
- Faculty of Physical Therapy, Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
study group
control group
Arm Description
the patients in this group will receive sensorimotor training for 6 weeks in addition to medical care.
the patients in this group will receive medical care only.
Outcomes
Primary Outcome Measures
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.
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
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
Secondary Outcome Measures
Proprioception of ankle joint
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04543032
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
March 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
the patients in this group will receive sensorimotor training for 6 weeks in addition to medical care.
Arm Title
control group
Arm Type
No Intervention
Arm Description
the patients in this group will receive medical care only.
Intervention Type
Other
Intervention Name(s)
sensorimotor training
Intervention Description
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
Primary Outcome Measure Information:
Title
Measurement of walking speed
Description
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.
Time Frame
change from baseline at six weeks
Title
Measurement of step length
Description
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
Time Frame
change from baseline at six weeks
Title
Measurement of stride length
Description
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
Time Frame
change from baseline at six weeks
Secondary Outcome Measure Information:
Title
Proprioception of ankle joint
Description
proprioception of ankle joint will be measured by Biodex Isokinetic dynamometer system (Biodex Medical Incorporated., Shirley, New York, USA).
Time Frame
change from baseline at six weeks
Title
Muscle strength of ankle dorsiflexors and plantar flexors
Description
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).
Time Frame
change from baseline at six weeks
Title
Assessment of Quality of life
Description
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
Time Frame
change from baseline at six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
ZIP/Postal Code
12613
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
26729347
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.
Results Reference
background
PubMed Identifier
30428863
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.
Results Reference
background
PubMed Identifier
27266093
Citation
Mizukami H. [Pathophysiology of diabetic polyneuropathy]. Nihon Rinsho. 2016 Apr;74 Suppl 2:229-33. No abstract available. Japanese.
Results Reference
background
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Sensorimotor Training and Gait in Diabetic Polyneuropathy
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