Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN.

Study Overview
=================
Brief Summary
-----------------
Upto the best knowledge of researcher, multisystem exercise program has been utilized in various populations, encompassing both healthy individuals and patients with diverse medical conditions. However, its specific impact on the diabetic peripheral neuropathy population, particularly in terms of improving balance, postural stability and mobility remains inadequately explored.

Detailed Description
-----------------
Diabetic peripheral neuropathy is a common and highly prevalent complication of type 2 diabetes mellitus, posing a significant global health concern. It affects a considerable number of individuals with diabetes, leading to progressive nerve damage and functional impairments. The multifaceted nature of this condition manifests in various ways, including sensory, motor, and autonomic dysfunction. Its insidious onset and gradual progression impose a substantial burden on patients, reducing their quality of life and presenting significant challenges for healthcare providers. Therefore, understanding the underlying causes, mechanisms, and management strategies of diabetic peripheral neuropathy is essential to alleviate its impact and enhance the overall well-being of those affected by this condition. Patients with diabetic peripheral neuropathy encounter a range of distressing symptoms that profoundly influence their daily activities. Sensory manifestations, such as numbness, tingling, and pain, are common, especially among older individuals with diabetes. Challenges in detecting temperature and touch also increase the risk of burns or injuries. Motor neuropathy results in muscle weakness, loss of balance, and coordination difficulties, making simple tasks like walking or holding objects more challenging. Furthermore, diabetic peripheral neuropathy plays a significant role in falls among elderly patients due to balance disorders and proprioception impairment. To address these issues and improve patients' quality of life, exercise has emerged as a valuable therapeutic intervention. Regular exercise programs, specifically those incorporating balance training exercises, have shown promising outcomes in enhancing balance and reducing falls among those with diabetic peripheral neuropathy. By emphasizing a comprehensive approach to exercise, targeting proprioception, coordination, and lower limb strength, patients can benefit from improved sensory integration, enhanced muscle control, and postural stability, ultimately promoting greater independence and reducing the risk of falls. Through a well-designed randomized controlled trial, exploring the effectiveness of a multisystem exercise program, further advancements in managing diabetic peripheral neuropathy can be achieved, leading to improved patient outcomes and enhanced quality of life.

Official Title
-----------------
Effects of Multisystem Exercise Program on Balance, Postural Stability, Mobility and Pain in Patients With Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Peripheral Neuropathy

Intervention / Treatment
-----------------
* Other: Multisystem Exercise
* Other: Conventional Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders (male, female) Age (40-60) Patients who are screened for diabetic peripheral neuropathy Moderate balance impairment on BBS (21-40) Patients who met the criteria of DN4 scored equal or greater than 4. Patients who have positive sharpened Romberg test Exclusion Criteria: Patients with any recent surgery of lower limb Patients with crutches Patients with gangrene Patients with lower BMI patients with DVT patients with amputations Patients with neurological impairments in the central nervous system and vestibular system Patients with orthostatic hypotension

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Experimental group will receive education on diabetes and conventional treatment exercises. The interventional multisystem exercises program will consist of four components, with each exercise lasting for a duration of 10 minutes per session. These components encompass proprioception training, balance exercises, strengthening routines, and reaction time training. This total multisystem exercises session will be performed for 30 minute, 3 times a week for 8 weeks in total. | Other: Multisystem Exercise<br>* Proprioception: Seated ankle ball. Single leg stance (hip ﬂexion) with support and with ﬂexion and extension of knees. Single leg stance (hip extension) with support and with ﬂexion and extension of knees. Muscle strengthening: Seated alternate double knee lifts with weights. Modiﬁed chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights. Balance Training Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support.. Crossover with support Reaction time Seated alternate touches to front. Seated alternate touches to back. Seated alternate touches to side. Seated alternate touches to 3 steps (forward, side, backward).<br>* Other names: Experimental Group;|
| Other: Control group<br>Control group will receive health education on diabetes. Conventional treatment will include Stretching, ROM exercise , balance and strengthening for 10 minutes each exercise in one session. Each stretch holds for 15-20 sec. This exercise session will be performed for 30 minute, 3 times a week for 8 weeks in total. | Other: Conventional Treatment<br>* ROM exercises Passive ROM exercise of hip. Passive ROM exercise of knee. Passive ROM exercise of ankle Muscle strengthening Seated alternate double knee lifts with weights. Modiﬁed chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights. Balance Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support. Crossover with support Stretching exercises Stretching exercise of hamstring. Stretching exercise of quadriceps. Stretching exercise of calf muscle<br>* Other names: Control Group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beg Balance Scale | It is used to assess balance. , Change will be measured from Baseline to 8 weeks | 8 weeks | 
| Functional reach test | It is a widely used clinical assessment tool to measure an individual's dynamic balance and stability. change will be measured from baseline to 8 weeks | 8 weeks | 
| .Timed Up and Go Test | It is for the assessment of lower extremity function, mobility and fall risk. Change will be measured from Baseline to 6 weeks | 8 weeks | 
| 10-m walk test: | It is a performance measure used to assess walking speed in meters per second over a short distance. | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Balance, Multisystem Exercise, Peripheral neuropathy