Isokinetic Strength and Balance Assessment in Diabetic Patients

Diabetes Clinical Trial

Official title:

Ankle Isokinetic Strength and Balance Assessment in Diabetic Patients With and Without Peripheral Neuropathy at Different Angular Velocities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05770154
• Other study ID #: isokinetic in diabetic
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: February 2024

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: Doaa A Elimy, phD
• Phone: 00201066474654
• Email: do3aayoub25[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
Egypt	Doaa Ayoub Elimy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak torque	Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors peak torque at different angular velocities.	Through study completion, an average of 6 months.
Secondary	Power	Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors power at different angular velocities.	Through study completion, an average of 6 months.
Secondary	Work	Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors work at different angular velocities	Through study completion, an average of 6 months.
Secondary	Dynamic balance	Biodex balance system will be used to assess dynamic balance.	Through study completion, an average of 6 months.