An interventional study of Balance exercises and Resisted exercises in Diabetic Peripheral Neuropathy, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy.
This randomized clinical trial will be conducted at Mumtaz Bakhtawar Hospital in 7 months after the approval of synopsis. The sample size for this trial will be 58 patients with DPN. Participants those meet inclusion criteria will be randomly allocated into two groups using online randomization tool, 29 participants will be assigned to Group A which will receive Balance training exercises for 35 minutes and Group B will receive Resistance Training exercises for 45 minutes. Each participant will receive intervention for 3 alternate days per week for 8 weeks.
The Michigan neuropathy screening instrument will be used for the assessment of DPN symptoms scores at baseline. Balance will be evaluated using the De Morton mobility index (DEMMI) test, while painDIRECT tool will be utilized to measure pain. The data will be entered and analyzed using SPSS version 24 for windows software.
1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.
This study's enrollment of 58 is below the median of 75 across 1,089 interventional studies indexed under Agnosia.
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Exclusion Criteria:
Group A will receive a session of balance exercises for 45 minutes.Treatment session will be given for 3 days per week for 8 weeks.This balance exercise program consist of three phases.Warm-up phase(5 minutes,after warm-up phase 35 minutes balance exercises then cooling phase (5 minutes).
Other: Balance exercises
Group B will receive a session of resisted exercises for 45 minutes.Treatment session will be given for 3 days per week for 8 weeks.This resisted exercises program consist of three phases.Warm-up phase(5 minutes,after warm-up phase 35 minutes balance exercises then cooling phase (5 minutes).
Other: Resisted exercises
Balance exercises includes active movements (flexion, extension, abduction, adduction) of one upper extremity and lower extremity, trunk movements (bending forward and rotation), raising heel, raising toes and raising heel. Every move in each session will be hold for 30 seconds. The part B comprises of training i.e., holding positions in standing posture which include moving the ball up and down in a straight line with two upper extremities, moving the ball up and down in an oblique line with two upper extremities, moving the ball forward and backward with left and right lower extremities, moving the ball laterally with left and right lower extremities, throwing the ball against the wall with hand and throwing the ball against the wall with foot.
The resistance training protocol include shoulder flexion and extension with 1 kg weight, shoulder pulley with 2 kg weight, arm curls with 1 kg weight, wall push-ups, bridging, hip abduction and adduction against resistance band, knee extensions and flexion in sitting position with resistance applied by contralateral limb, knee adduction and abduction with resistance band, mini squats, strengthening exercise for toes flexor and extensor (22), resisted inversion and eversion and straight leg raise (SLR) with 1 kg ankle weight (10). Every move in each session comprises of 2 sets of 3 reps each and 1 set will be added at 4th and 8th week.
Michigan neuropathy screening instrument
This screening tool consists of two sections: Section A, self-administered by the patient, involves 15 yes/no questions about clinical symptoms, and Section B is based on a clinical evaluation. Positive and negative sensory symptoms, cramps, muscle weakness, foot ulcers, cracks, and amputation are assessed.
Time frame: 8th week
De Morton mobility index test
It consists of 15 items covering a broad spectrum of mobility levels and it has shown satisfactory Clinometric properties (30). In this method, the static balance is measured on one leg and two legs, as well as at the closing of the eyes; on the other hand, the dynamic balance is measured and evaluated when the patient jumps and moves four steps back.
Time frame: 8th week
PainDETECT Tool
painDETECT scale to detect diabetic neuropathic pain which includes symptom questioning and also the type, severity and the radiation of pain.
Time frame: 8th week
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2024 to primary completion in Sep 2024, 7 months.
Of 606 non-industry interventional studies with no phase under Agnosia, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's 7 months is below that.
Counting every sponsor, half of 615 studies reached it within 12 months; a quarter within 5 and three quarters within 26.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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