Clinical trial NCT05770154: Isokinetic Strength and Balance Assessment in Diabetic Patients
Official title: Ankle Isokinetic Strength and Balance Assessment in Diabetic Patients With and Without Peripheral Neuropathy at Different Angular Velocities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: diabetes,
diabetic polyneuropathy
isokinetic
muscle strength
dynamic balance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: diabetic patient

Brief summary: Diabetic polyneuropathy (DPN) is a type of nerve damage that can occur in diabetics. It can cause weakness and a loss of sensation, particularly in the legs and feet. This can have an impact on muscle strength and balance, making walking more difficult and increasing the risk of falling. Evaluating ankle muscular strength and balance using quantitative and standardised tools is critical for patients with and without DPN as well as determining how much DPN affects ankle muscle strength and balance.

Detailed description: Diabetic Peripheral Neuropathy (DPN) can affect ankle muscle strength and increase the risk of falling. This occurs due to nerve damage that impairs muscle function and reduces sensitivity in the feet, leading to difficulty maintaining balance and coordination. Risk factors for DPN-related falls include poor glycemic control, the duration of diabetes, age, and other comorbidities such as peripheral vascular disease. It is important for individuals with diabetes to regularly monitor and manage their DPN to prevent falls and maintain overall health. So, conducting this study to measure ankle muscle strength through isokinetic testing and dynamic balance through the Biodex balance system will help researchers quantify the extent of DPN's impact on these aspects. This study can provide a valuable predictor and assessment tool for determining the severity of neuropathy in diabetic patients. The results of this study could also help identify those at a higher risk for falls and diabetic foot complications. This information can aid healthcare providers in developing tailored interventions to improve muscle strength and balance and reduce the risk of falls in individuals with diabetes and DPN.

Eligibility criteria: Inclusion Criteria:

1. Patients aged from 40 to 55 years for both gender.
2. Patients with diabetes for more than 5 years.
3. Diabetic polyneuropathy was diagnosed by a neurologist.
4. Their BMI from 18 to 24.9 kg/m2.
5. The study population must be willing to participate in the study.

Exclusion Criteria:

1. Patients with marked deformities of the lower limbs, foot ulcers and Charcot foot.
2. .Patients with any other neurological or orthopedic diseases that may affect balance.
3. Patients with marked weakness or drop foot.
4. Patients with amputation, mental deficits, liver or renal diseases.
5. patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment

Primary outcomes:
measure: Peak torque
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
measure: Power
timeFrame: Through study completion, an average of 6 months.
measure: Work
timeFrame: Through study completion, an average of 6 months.
measure: Dynamic balance
timeFrame: Through study completion, an average of 6 months.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Doaa Ayoub Elimy
Study officials:
affiliation: Cairo University
name: Doaa A Elimy, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Misr University for Science and Technology
name: Khaled T Ahmed, Ass. prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Misr University for Science and Technology
name: Wafaa A Abd Allah, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Misr University for Science and Technology
name: Mohamed F Abdel-lateef, phD
role: PRINCIPAL_INVESTIGATOR
References: