Isokinetic Strength and Balance Assessment in Diabetic Patients

Completed

• Conditions: Diabetes

• Registration Number: NCT05770154
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-03-03
• Study Start: 2023-03-15
• Study First Posted: 2023-03-15
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-15
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak torque	Through study completion, an average of 6 months.	Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors peak torque at different angular velocities.

Secondary Outcome Measures

Name	Time	Method
Power	Through study completion, an average of 6 months.	Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors power at different angular velocities.
Work	Through study completion, an average of 6 months.	Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors work at different angular velocities
Dynamic balance	Through study completion, an average of 6 months.	Biodex balance system will be used to assess dynamic balance.

Trial Locations

Locations (1)

Doaa Ayoub Elimy; 🇪🇬 Cairo, Egypt