Old Age; DebilityNCT05122156
Correlation of Berg Balance Scale, Time up and Go and Dynamic Gait Index Scale in Elderly
An observational study of Old Age; Debility, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will find a correlation Between Berg Balance scale, Time up and Go and Dynamic Gait Index Scale in community Dwelling Ambulatory Elderly. It will be comparative cross sectional survey that will be evaluate which scale is best one for quick screening of elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age; Debility
- How many people
- 125 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Aug 2021to 30 Jan 2022
- 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 65 years and older
- All sexes
- Older adult
Study population: Elderly patients more than 65 years age
Who may be able to join
- 65 or above 65 years old. Both male and Females. Living independently in the community. Walking without any aid. Minimental state examination score more than 25
Who cannot join
- Diagnosed neuromuscular condition. Diagnosed cardiorespiratory conditions. Diagnosed cognitive impairment. Uncorrected visual and auditory deficit
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 54000
About this study
Official title: Correlation of Berg Balance Scale, Time up and Go and Dynamic Gait Index Scale in Community Dwelling Ambulatory Elderly
This study will find a correlation Between Berg Balance scale, Time up and Go and Dynamic Gait Index Scale in community Dwelling Ambulatory Elderly. It will be comparative cross sectional survey that will be evaluate which scale is best one for quick screening of elderly. This study will be completed within the time duration of 6 month. Convenient sampling technique will be used to collect the data. 125 sample size will be taken, in this study to find the correlation between Berg Balance scales. Time up and Go and Dynamic Gait index scale in community dwelling ambulatory elderly. In this study all subjects perform Mini-mental state examination test to meet the inclusion criteria of the study it will be above than 25 than all subjects perform Berg Balance test, Time up and Go test and Dynamic Gait Index test then interpret their values to find the best one scale for screening of elderly. . In this study subjects included will be living independently in the community and also those who walk without any aid. Those subjects who are diagnosed with neuromuscular condition, cardiorespiratory condition, cognitive impairment and having uncorrected auditory and visual deficit will be excluded from this study. In this study we will check the static, proactive part of the dynamic balance, their gait impairments and also the risk of fall of elder population. Pearson correlation Data will be analyzed on SPSS 25.
- Conditions
- Old Age; Debility
- Medical subject headings
- Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination test
n 1975(Folstein and McHugh) the mini-mental state test was developed and has since widely been used in clinical and research settings. This scale will be used to assess the cognition of the subjects.it is a screening tool of 30 component.
A qualified person takes 10 minutes to complete. A score of moderate (10-20 points) and mild(21-24 points) and less than 9 score indicate significant cognitive impairment. Normal cognition is demonstrated by a score of 25 and above
Measured: Single reading
Berg Balance Scale
Berg Balance scale is a performance-based balance test scale of 14 items. on an ordinal scale each subject is scored (0-4).Total test score range from 0(lowest ability to balance) to 56(highest balance ability.The items analyses the ability of the subject to sustain increasingly challenging positions or movements by decreasing the base of support from sitting and standing to single-leg-position
Measured: Single reading
Time Up and Go test
Time up and go test is a successful screening method to evaluate the chance of falling. The American and British Recommendations on clinical practice Geriatric societies suggest that the TUG test be used as a primary indicator of functional assessment. Walking pace, muscle strength and balance, sit-to-walk transition time, turning, walking and walk-to-sit transition are expressed in Time Up and Go test. Participants take greater than 12 seconds to complete TUG will be at greater risk of fall
Measured: Single reading
The Dynamic Gait index (DGI)
The Dynamic Gait index (DGI) is a method for clinical evaluation that uses a variety of gait related activities to determine the dynamic balance and risk of falling in older adults. Subjects score less than 19/24 will be at risk of falling. This scale will also be use to check the gait impairment of the elderly.
Measured: Single reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start15 Aug 2021
- Primary completion15 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old Age; DebilityStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122156
- Sponsor's protocol ID
- RiphahIU Sajidia bibi
- Status last verified
- Apr 2022
- First submitted
- 8 Nov 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Berg Balance Scale, Time up and Go and Dynamic Gait Index Scale in Community Dwelling Ambulatory Elderly
- ClinicalTrials.gov ID
- NCT05122156
- Acronym / sponsor ID
- RiphahIU Sajidia bibi
- Conditions
- Old Age; Debility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 16 Nov 2021 (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.
This study will find a correlation Between Berg Balance scale, Time up and Go and Dynamic Gait Index Scale in community Dwelling Ambulatory Elderly. It will be comparative cross sectional survey that will be evaluate which scale is best one for quick screening of elderly. This study will be completed within the time duration of 6 month. Convenient sampling technique will be used to collect the data. 125 sample size will be taken, in this study to find the correlation between Berg Balance scales. Time up and Go and Dynamic Gait index scale in community dwelling ambulatory elderly. In this study all subjects perform Mini-mental state examination test to meet the inclusion criteria of the study it will be above than 25 than all subjects perform Berg Balance test, Time up and Go test and Dynamic Gait Index test then interpret their values to find the best one scale for screening of elderly. . In this study subjects included will be living independently in the community and also those who walk without any aid. Those subjects who are diagnosed with neuromuscular condition, cardiorespiratory condition, cognitive impairment and having uncorrected auditory and visual deficit will be excluded from this study. In this study we will check the static, proactive part of the dynamic balance, their gait impairments and also the risk of fall of elder population. Pearson correlation Data will be analyzed on SPSS 25.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients more than 65 years age
Key inclusion criteria (1 listed)
- 65 or above 65 years old. Both male and Females. Living independently in the community. Walking without any aid. Minimental state examination score more than 25
Key exclusion criteria (1 listed)
- Diagnosed neuromuscular condition. Diagnosed cardiorespiratory conditions. Diagnosed cognitive impairment. Uncorrected visual and auditory deficit
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
Mini-Mental State Examination test
Time frame: Single reading
n 1975(Folstein and McHugh) the mini-mental state test was developed and has since widely been used in clinical and research settings. This scale will be used to assess the cognition of the subjects.it is a screening tool of 30 component. A qualified person takes 10 minutes to complete. A score of moderate (10-20 points) and mild(21-24 points) and less than 9 score indicate significant cognitive impairment. Normal cognition is demonstrated by a score of 25 and above
Berg Balance Scale
Time frame: Single reading
Berg Balance scale is a performance-based balance test scale of 14 items. on an ordinal scale each subject is scored (0-4).Total test score range from 0(lowest ability to balance) to 56(highest balance ability.The items analyses the ability of the subject to sustain increasingly challenging positions or movements by decreasing the base of support from sitting and standing to single-leg-position
Time Up and Go test
Time frame: Single reading
Time up and go test is a successful screening method to evaluate the chance of falling. The American and British Recommendations on clinical practice Geriatric societies suggest that the TUG test be used as a primary indicator of functional assessment. Walking pace, muscle strength and balance, sit-to-walk transition time, turning, walking and walk-to-sit transition are expressed in Time Up and Go test. Participants take greater than 12 seconds to complete TUG will be at greater risk of fall
The Dynamic Gait index (DGI)
Time frame: Single reading
The Dynamic Gait index (DGI) is a method for clinical evaluation that uses a variety of gait related activities to determine the dynamic balance and risk of falling in older adults. Subjects score less than 19/24 will be at risk of falling. This scale will also be use to check the gait impairment of the elderly.
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 6 Apr 2022.
- 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.
Tehreem Mukhtar, MS principal investigator
Riphah International University
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 Old Age; Debility, 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 1 inclusion and 1 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 6 Apr 2022. 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?
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?
Mini-Mental State Examination test (time frame: Single reading). The study lists 4 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 6 Apr 2022.