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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP A (BALANCE EXERCISES) | Experimental | 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). |
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| GROUP B (RESISTED EXERCISES) | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance exercises | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 8th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Kashif, PhD-PT | Riphah International University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riphah International University | Lahore | Punjab Province | 54660 | Pakistan |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
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| Resisted exercises | Other | 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. |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |