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

Diabetic Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06240910
• Other study ID #: REC/RCR&AHS/23/0236
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: February 12, 2024

Study information

• Verified date: January 2024
• Source: Riphah International University
• Contact: Muhammad Usman, MSPT(NM)
• Phone: 03123381314
• Email: usmanikram993[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: February 12, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 67 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
Pakistan	Ripha international university	Lahore	Punjab
Pakistan	Riphah international university	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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	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