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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06240910
Enrollment
32
Registered
2024-02-05
Start date
2023-07-17
Completion date
2024-02-12
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Keywords

Aerobic exercise training, Balance and fall, Diabetic neuropathy, Neural mobilization

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.

Interventions

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.

OTHERAerobic 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

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 67 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Berge balance scale6 weeksThe 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

MeasureTime frameDescription
Functional reach test6 weeksFunctional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.

Other

MeasureTime frameDescription
Morse scale6 weeksThis 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.
Romberg test6 weeksThe 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).
Michigan neuropathy screening instrument questionnaire6 weeksThe 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.

Countries

Pakistan

Contacts

Primary ContactMuhammad Usman, MSPT(NM)
usmanikram993@gmail.com03123381314
Backup ContactMuhammad Aqeel, MSPT(NM)
ilyassaqeel@gmail.com03037862835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026