Effects of Aerobic Training and Neurodynamics to Prevent Fall and Improve Balance in Patients With Diabetic Neuropathy

Not Applicable

Recruiting

• Conditions: Diabetic Neuropathies
• Interventions: Other: Neurodynamics; Other: Aerobic training

• Registration Number: NCT06240910
• Lead Sponsor: Riphah International University

Brief Summary

Diabetes is a group of metabolic diseases, characterized by hyperglycemia resulting from defects in insulin secretion, actionor both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of differentorgans, especially the eyes, kidneys, nerves, heart, and blood vessels. In long standing cases of both diabetes type 1 and 2, about 60 % individuals had diabetic neuropathy. Patients suffering from diabetes are more prone to fall, possibly due to balance issues and sensory ataxia.

Detailed Description

This study will be a Randomized controlled trial. Participants who have DM2 for past 7 years and who score \>2/13 on Michigan neuropathy screening instrument questionnaire with at least 2 DPN symptoms will be screened for this study. Participants with any fracture in lower limb , complete loss of foot perception, comorbidities, using assistive devices and already involved in structured physiotherapy interventional program will be excluded from this randomized controlled trial study. Participants will be selected with non-probability consecutive sampling and will be randomly allocated using computer generated randomizer in two groups i.e., experimental group and control group. Balance and risk of fall will be assessed through Berg Balance scale, functional reach test , Romberg test and morse fall scale before and after giving interventions. Treatment session will be given 3 days a week for 6 weeks. Participants in control group will be given neurodynamics for sciatic nerve ( the total duration of interventions will be approximately 10 minutes a day for 3 days in a week for 6 weeks. Experimental group will be given aerobic exercise interventions (involving warm-up by stretching and flexibility exercisesfor 5 minutes, treadmill walking and stationary bicycle training with 6 minutes a day for 3 days in a week for 6 weeks) along with neural mobilization for sciatic nerve ( 10 minutes a day for 3 days in a week for 6 weeks), so the total duration of interventions for experimental group will be 40-60 minutes a day for 3 days in a week for 6 weeks. Given the high prevalence and substantial impact of diabetic neuropathy on balance and fall risk, it is imperative to explore effective interventions (aerobic exercise + neurodynamics) for managing these impairments. Individuals may experience improved proprioception, enhanced muscle coordination, and optimized neural tissue mobility, leading to reduced fall risk and improved functional independence. Data will be analyze using SPSS 23.

Study Timeline

• Study Start: 2023-07-17
• Status Verified: 2024-01
• Study First Submitted: 2024-01-28
• Study First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-01-28
• Study First Posted: 2024-02-05
• Last Update Posted: 2024-02-05
• Primary Completion: 2024-02-12
• Study Completion: 2024-02-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Age ranged between 45-67 years.

• Both male and female genders
• DM for the past 7 years.
• Scored >2/13 on Michigan neuropathy screening instrument (MNSI) questionnaire including at least two DPN symptoms.

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Exclusion Criteria

fracture(s) in the lower limb.

• Any participant who suffered from foot ulcers.
• Unstable heart disease, co- Morbid conditions limiting exercise
• inability of subjects to understand and/or co-operate during quantitative sensory testing or manual/nerve mobility testing and/or treatment.
• Any level of physical activity i.e 150 minutes/week
• Receiving any structured supervised physiotherapy interventions.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurodynamics	Neurodynamics	Neuro dynamics involving Stretching and gliding of the Sciatic nerve (performing each exercise for 30 s at a slow and comfortable pace of 1 repetition per \~3-4 s. The participants rested for 60 s between each exercise. The total duration of the interventions was approximately 10 min.).The whole treatment session on a single day will be of 40-60 minutes of duration (involving both aerobic exercise + neurodynamics) 3. times a week for 6 weeks according to the American diabetes association, accumulating a minimum of 150 minutes/week.
Aerobic training	Aerobic training	Aerobic exercise will involve warm-up by stretching and flexibility exercises for 5 minutes, Treadmill walking for 6 minutes, and Stationary bicycle for 6 minutes

Primary Outcome Measures

Name	Time	Method
Berge balance scale	6 weeks	The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.

Secondary Outcome Measures

Name	Time	Method
Functional reach test	6 weeks	Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.

Trial Locations

Locations (2)

Ripha international university; 🇵🇰 Lahore, Punjab, Pakistan

Riphah international university; 🇵🇰 Lahore, Punjab, Pakistan