DiabetesNCT05770154
Isokinetic Strength and Balance Assessment in Diabetic Patients
An observational study of Diabetes, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Diabetes
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: diabetic patient
Who may be able to join
- Patients aged from 40 to 55 years for both gender.
- Patients with diabetes for more than 5 years.
- Diabetic polyneuropathy was diagnosed by a neurologist.
- Their BMI from 18 to 24.9 kg/m2.
- The study population must be willing to participate in the study.
Who cannot join
- Patients with marked deformities of the lower limbs, foot ulcers and Charcot foot.
- .Patients with any other neurological or orthopedic diseases that may affect balance.
- Patients with marked weakness or drop foot.
- Patients with amputation, mental deficits, liver or renal diseases.
- patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ankle Isokinetic Strength and Balance Assessment in Diabetic Patients With and Without Peripheral Neuropathy at Different Angular Velocities
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.
Read the 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.
- Conditions
- Diabetes
- Keywords
- diabetes,, diabetic polyneuropathy, isokinetic, muscle strength, dynamic balance
- Medical subject headings
- Diabetes Mellitus, Diabetic Neuropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak torque
Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors peak torque at different angular velocities.
Measured: Through study completion, an average of 6 months.
Secondary outcomes (3)
Power
Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors power at different angular velocities.
Measured: Through study completion, an average of 6 months.
Work
Isokinetic dynamometer will be used for measuring ankle dorsi and planter flexors work at different angular velocities
Measured: Through study completion, an average of 6 months.
Dynamic balance
Biodex balance system will be used to assess dynamic balance.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start15 Mar 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Ayoub Elimy Mohammed, Cairo University
- Investigators
- Doaa A Elimy, phD, Principal investigator, Cairo UniversityKhaled T Ahmed, Ass. prof, Principal investigator, Misr University for Science and TechnologyWafaa A Abd Allah, phD, Principal investigator, Misr University for Science and TechnologyMohamed F Abdel-lateef, phD, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770154
- Sponsor's protocol ID
- isokinetic in diabetic
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Isokinetic Strength and Balance Assessment in Diabetic Patients With and Without Peripheral Neuropathy at Different Angular Velocities
- ClinicalTrials.gov ID
- NCT05770154
- Acronym / sponsor ID
- isokinetic in diabetic
- Conditions
- Diabetes
- Keywords
- diabetes,, diabetic polyneuropathy, isokinetic, muscle strength, dynamic balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- diabetic patient
Key inclusion criteria (5 listed)
- Patients aged from 40 to 55 years for both gender.
- Patients with diabetes for more than 5 years.
- Diabetic polyneuropathy was diagnosed by a neurologist.
- Their BMI from 18 to 24.9 kg/m2.
- The study population must be willing to participate in the study.
Key exclusion criteria (5 listed)
- Patients with marked deformities of the lower limbs, foot ulcers and Charcot foot.
- .Patients with any other neurological or orthopedic diseases that may affect balance.
- Patients with marked weakness or drop foot.
- Patients with amputation, mental deficits, liver or renal diseases.
- patients who had a previous surgical history (within 6 months) were also excluded prior to the baseline assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak torque
Time frame: 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.
3 secondary outcomes
Power
Time frame: Through study completion, an average of 6 months.
Work
Time frame: Through study completion, an average of 6 months.
Dynamic balance
Time frame: Through study completion, an average of 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Yes. Study results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa A Elimy, phD principal investigator
Cairo University
Khaled T Ahmed, Ass. prof principal investigator
Misr University for Science and Technology
Wafaa A Abd Allah, phD principal investigator
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak torque (time frame: Through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.