An interventional study of Antigravity treadmill training and Conventional exercise program in Diabetic Polyneuropathy, sponsored by Umm Al-Qura University. Completed at 1 site in Saudi Arabia. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-22.
Sponsored by Umm Al-Qura University · Not applicable, Interventional, and Treatment
Aging can be defined as sequential deterioration that occurs in elderly people including weakness, loss of mobility, decline of physical capabilities, increase susceptibility to disease and many other age-related physiological changes .The beginning of old age in most developed countries is about 60 or 65 years old. Diabetes mellitus (DM) and most commonly type 2 DM is one of the most common chronic non-communicable diseases affecting old people in Saudi Arabia which might be resulted from decline in physical activities. Polyneuropathy (PN) and its serious consequences represent the most common complication in diabetic mellitus which could contribute to an increased gait abnormality and risk of falling.
Disability and reduction of quality of life are the largest costs of diabetes and its complications. So taking active intervention to reduce the risk of falls, improve gait performance and improve the quality of life in elderly with DPN is very important. Lower extremity aerobic exercise training via treadmill aiming for improving patients' physical activity levels is an important part in the rehabilitation program to enhance balance and walking functions and reducing the fall risk, .Treadmill training using s low-load walking provided by an emerging technology called lower body positive pressure (LBPP) that effectively reduces body weight could be preferable than other methods of unweighting treadmill because the air pressure is applied uniformly over the lower body. This kind of anti-gravity treadmill is ideal in reducing the formation of pain and pressure points that are common with harness-based unweighting systems. Many other advantages are also associated with this unique type of antigravity technology that could give it the superiority than the other types of unweighting treadmills in enhancing walking performance, reducing the risk of fall and improving quality of life in Saudi elderly people with DPN.
256 studies on the registry are indexed under Polyneuropathies; 50 are open to participants now.
This study's enrollment of 50 is below the median of 75 across 162 interventional studies indexed under Polyneuropathies.
Browse Polyneuropathies studies →Umm Al-Qura University is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
This group received antigravity treadmill training 100% weight bearing and conventional exercise program.
Other: Antigravity treadmill training · Other: Conventional exercise program
This group received the conventional exercise program only.
Other: Conventional exercise program
This group received antigravity treadmill training 100% weight bearing
This group received the conventional exercise program only.
Change from baseline spatial and temporal gait parameters at 3 months
Spatial and temporal gait analysis will be evaluated for every patient at baseline and 3 months post-intervention by using the 3-D motion analysis system.
Time frame: Baseline and 3 months post-intervention
Change from baseline postural stability at 3 months
Postural stability assessment by using Balance Biodex stability system measuring (antero-posterior, medio-lateral, and overall stability indices.
Time frame: Baseline and 3 months post-intervention
Change from baseline functional capacity at 3 months
The assessment of functional capacity will be done using Six Minute Walk Test where intensity is moderately higher than daily living activities. Subject will be asked to walk at his own maximal pace from end to end of a 40-meter flat, straight corridor marked every 1 meter with side cones, in order to cover as much ground as possible while maintaining a steady pace without running during the allowed time. No verbal encouragement will be given, and subjects will be informed verbally each 2 minutes of the remaining time. The patients will be allowed to stop, but they can start again, if possible, within the allocated 6 minutes. Distance covered in 6 minutes will be recorded in meter. The longer the distance that will be walked will signify a better performance.
Time frame: Baseline and 3 months post-intervention
Plan to share: No
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Umm Al-Qura University