Clinical trial NCT06240910: Effects of Aerobic Training and Neurodynamics to Prevent Fall and Improve Balance in Patients With Diabetic Neuropathy
Official title: Effects of Aerobic Training and Neurodynamics to Prevent Fall and Improve Balance in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Aerobic exercise training
Balance and fall
Diabetic neuropathy
Neural mobilization
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Berge balance scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Functional reach test
timeFrame: 6 weeks
Other outcomes:
measure: Morse scale
timeFrame: 6 weeks
measure: Romberg test
timeFrame: 6 weeks
measure: Michigan neuropathy screening instrument questionnaire
timeFrame: 6 weeks
Locations:
city: Lahore
country: Pakistan
facility: Ripha international university
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Asrar Yousaf
role: PRINCIPAL_INVESTIGATOR
References: