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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Neuropathies
• Intervention / Treatment: Other: Neurodynamics; Other: Aerobic training

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Aqeel, MSPT(NM); Phone Number: 03037862835; Email: ilyassaqeel@gmail.com
• Study Contact Backup: Name: Muhammad Usman, MSPT(NM); Phone Number: 03123381314; Email: usmanikram993@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 5433
      • Recruiting
      • Ripha International University
      • Contact: Asrar Yousaf; Phone Number: 030040995505; Email: asrar.yousaf@riphah.edu.pk
      • Principal Investigator: Asrar Yousaf
      • Contact: Muhammad Aqeel, MSPT(NM); Phone Number: 03037862835; Email: ilyassaqeel@gmail.com
      • Sub-Investigator: Doctor Wajiha
    • Lahore, Punjab, Pakistan, 5433
      • Recruiting
      • Riphah International University
      • Contact: Muhammad Usman, MSPT(NM); Phone Number: 03123381314; Email: usmanikram993@gmai.com
      • Contact: Muhammad Asrar Yousaf, MSPT(NM); Phone Number: 03004099505; Email: asrar.yousaf@riphah.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berge balance scale	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.	6 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morse scale	This scale was published by Morse in 1989 and consists of six criteria for assessing the risk of falls: history of falling, secondary diagnosis, ambulatory aid, intravenous therapy/heparin lock, gait, and mental status.	6 weeks
Romberg test	The Romberg test is a test that measures a persons sense of balance. Specifically, the test assesses the function of the dorsal column of the spinal cord (the dorsal column is responsible for proprioception).	6 weeks
Michigan neuropathy screening instrument questionnaire	The Michigan Neuropathy Screening Instrument (MNSI) is a valid screening tool for DN(19). The maximum score of the foot examination is 8 points and a score of equal to or greater than 2 is positive for DPN.	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Muhammad Asrar Yousaf, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): February 12, 2024
• Study Completion (Estimated): February 12, 2024

Study Registration Dates

• First Submitted: January 28, 2024
• First Submitted That Met QC Criteria: January 28, 2024
• First Posted (Estimated): February 5, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Diabetic neuropathy; Aerobic exercise training; Neural mobilization; Balance and fall
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: REC/RCR&AHS/23/0236

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No