Peripheral NeuropathyNCT06130865
Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy
An observational study of Peripheral Neuropathy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Their is limited literature available regarding the assessment of balance by Fullerton Advanced Balance scale in patients with diabetic peripheral neuropathy, previous studies have only focused on the use of berg balance scale and mini-BESTest. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Peripheral Neuropathy
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Nov 2023to 10 May 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Study Design: The study design is a prospective cohort study, where a group of participants will be followed over time to observe changes in patient outcomes after receiving physiotherapy interventions. Study Setting: Data for this study will be collected from the Irus Clinic and Rehabilitation Center Multan Study Duration: The study will span a period of six months, commencing after receiving approval from the Bioethical Review Board (BASR). Sample Size: The study will include a total of 104 participants.
Who may be able to join
- Either gender.
- Age between 40 to 60 years
- Known history of diabetes mellitus treated with by oral hypoglycemic drugs or insulin therapy.
- Known case of diabetic peripheral neuropathy (DPN)
- Patients who met the criteria of DN4 scored equal or greater than 4.
- Patients who have positive SHARPEND ROMBERG TEST.
- Balance impairment on BBS (21-40).
Who cannot join
- Lower limb muscles strength less than 3 on manual muscle testing.
- Any inflammatory condition, congenital or acquired malformation, vestibular system pathologies.
- Contraindication for engaging in physical activity (osteoarthritis, orthostatic hypo tension or any acute illness).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The Irus Clinic and Rehabilitation Center
Multan, Punjab Province, 60000
Aruba Saeed, PHD, 03344399403, aruba.saeed@riphah.edu.pk
Faria Ali Shahid, MS
About this study
Their is limited literature available regarding the assessment of balance by Fullerton Advanced Balance scale in patients with diabetic peripheral neuropathy, previous studies have only focused on the use of berg balance scale and mini-BESTest. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the patients of diabetic peripheral neuropathy.
Read the detailed description
Diabetes is a serious, long-term condition with a major impact on the lives and well-being of individuals, families, and societies worldwide. Diabetic neuropathy is its most common clinical consequence. Diabetic Peripheral Neuropathy (DPN) is defined as "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes." A person with DPN is up to 20 times more likely to fall than a non-diabetic of the same age, making falls an even more significant therapeutic concern. As a result of decreased balance, people with DPN are predisposed to falls, which can lead to injury, decreased balance confidence, fear-related avoidance of activities, and decreased quality of life. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the population of DPN and it will also predict which of them is the most responsive and sensitive and first evaluates changes in balance of patients with DPN. After the comparison of responsiveness and sensitivity of these scales, it can predict the best tool for early assessment of balance impairment in the people with DPN. This study will be beneficial in early identification of fall risk and minimization of fall related injuries and complications.
- Conditions
- Peripheral Neuropathy
- Keywords
- Balance., Diabetes, Diabetic Peripheral Neuropathy, Otago Exercise Plan
- Medical subject headings
- Peripheral Nervous System Diseases, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
A clinical tool that assesses static and dynamic balance.
Measured: 8 Weeks
Mini Balance Evaluation Systems Test (mini-BESTest)
A clinical tool that assesses balance impairments by evaluating various components of balance control, including anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability during gait.
Measured: 8 weeks
Fullerton Advanced Balance Scale (FAB)
The FAB scale is a multi-item balance assessment test designed specifically to measure balance in higher-functioning active older adults.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start5 Nov 2023 (estimated)
- Primary completion10 Apr 2024 (estimated)
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- aruba saeed, PHD, Principal investigator, Riphah International University Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130865
- Sponsor's protocol ID
- REC/0246 Faria Ali Shahid
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness of Multiple Balance Assessment Tools in Patients With Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT06130865
- Acronym / sponsor ID
- REC/0246 Faria Ali Shahid
- Conditions
- Peripheral Neuropathy
- Keywords
- Balance., Diabetes, Diabetic Peripheral Neuropathy, Otago Exercise Plan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (estimated)
- Primary completion
- 10 Apr 2024 (estimated)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 14 Nov 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.
Their is limited literature available regarding the assessment of balance by Fullerton Advanced Balance scale in patients with diabetic peripheral neuropathy, previous studies have only focused on the use of berg balance scale and mini-BESTest. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the patients of diabetic peripheral neuropathy.
Detailed description
Diabetes is a serious, long-term condition with a major impact on the lives and well-being of individuals, families, and societies worldwide. Diabetic neuropathy is its most common clinical consequence. Diabetic Peripheral Neuropathy (DPN) is defined as "the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes." A person with DPN is up to 20 times more likely to fall than a non-diabetic of the same age, making falls an even more significant therapeutic concern. As a result of decreased balance, people with DPN are predisposed to falls, which can lead to injury, decreased balance confidence, fear-related avoidance of activities, and decreased quality of life. So, this study aims to assess the responsiveness and sensitivity of Berg Balance Scale, Mini-BESTest, and Fullerton Advanced Balance Scale in the population of DPN and it will also predict which of them is the most responsive and sensitive and first evaluates changes in balance of patients with DPN. After the comparison of responsiveness and sensitivity of these scales, it can predict the best tool for early assessment of balance impairment in the people with DPN. This study will be beneficial in early identification of fall risk and minimization of fall related injuries and complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study Design: The study design is a prospective cohort study, where a group of participants will be followed over time to observe changes in patient outcomes after receiving physiotherapy interventions. Study Setting: Data for this study will be collected from the Irus Clinic and Rehabilitation Center Multan Study Duration: The study will span a period of six months, commencing after receiving approval from the Bioethical Review Board (BASR). Sample Size: The study will include a total of 104 participants.
Key inclusion criteria (7 listed)
- Either gender.
- Age between 40 to 60 years
- Known history of diabetes mellitus treated with by oral hypoglycemic drugs or insulin therapy.
- Known case of diabetic peripheral neuropathy (DPN)
- Patients who met the criteria of DN4 scored equal or greater than 4.
Key exclusion criteria (3 listed)
- Lower limb muscles strength less than 3 on manual muscle testing.
- Any inflammatory condition, congenital or acquired malformation, vestibular system pathologies.
- Contraindication for engaging in physical activity (osteoarthritis, orthostatic hypo tension or any acute illness).
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
Berg Balance Scale
Time frame: 8 Weeks
A clinical tool that assesses static and dynamic balance.
Mini Balance Evaluation Systems Test (mini-BESTest)
Time frame: 8 weeks
A clinical tool that assesses balance impairments by evaluating various components of balance control, including anticipatory postural adjustments, reactive postural responses, sensory orientation, and stability during gait.
Fullerton Advanced Balance Scale (FAB)
Time frame: 8 weeks
The FAB scale is a multi-item balance assessment test designed specifically to measure balance in higher-functioning active older adults.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Individual participant dataSharing planned: No
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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.
aruba saeed, PHD principal investigator
Riphah International University Pakistan
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 Peripheral Neuropathy, run by Riphah International University at 1 site in Pakistan.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Nov 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 8 Weeks). The study lists 3 primary outcomes in all. 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 14 Nov 2023.