BalanceNCT04867486
Urdu Version of the Dynamic Gait Index: Reliability and Validity Study
An observational study of Balance, run by Riphah International University at 1 site in Pakistan.
Trial summary
In this study, Investigators will observe the reliability and validity of dynamic gait index in Urdu language in Pakistani geriatric population with balance impairments. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Balance
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2021to 20 Aug 2021
- 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 to 80 years
- All sexes
- Older adult
Study population: Elderly people, especially those of the advanced ages, suffer from coexistent disorders, many of which are chronically degenerative, falls and gait disorders are common issues. About one-third of all elderly people aged 65 as well as above fall at least once a year. Injury, physical impairments, morbidity, cognitive side effects, and even disability are all linked to fall because equilibrium and postural control are essential for the everyday work.
Who may be able to join
- Age at least 65 years
- Ability to walk a minimum of 6m with or without a walking Aid
- One or more falls in the last year or
- Observed balance impairment evaluated subjectively by a physical therapist during the initial training session (Time Up and Go test, Morse Fall Scale)
Who cannot join
- Inability to understand or follow the instructions of the DGI
- Experience with the DGI in the last 6 months
- Acute illness or fracture in the lower extremities or knee/hip replacement within the last 3 months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Faisalabad, Punjab Province, 3800
About this study
Official title: Reliability and Validity of Urdu Version of the Dynamic Gait Index in Pakistani Geriatric Population
In this study, Investigators will observe the reliability and validity of dynamic gait index in Urdu language in Pakistani geriatric population with balance impairments.
Read the detailed description
The aim of study is to translate and culturally adapt DGI into Urdu language and secondly to investigate the reliability and validity of DGI in geriatrics Pakistani population.This study will be cross sectional survey in which convenience sampling technique will be used to enroll participants as per pre-defined criteria.
The results of study will help to know the validity and reliability of DGI in Urdu version with balance impairments in geriatric population.The reliability of the scale will be checked through internal consistency and test-retest methods. Internal consistency will be analyzed with Cronbach's alpha value.Test-retest reliability will be assessed using an intraclass correlation coefficient with 60 patients
- Conditions
- Balance
- Keywords
- Dynamic gait index, balance, reliability, validity, geriatric population
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index
The Dynamic Gait Index tests the participant's ability to maintain balance while walking under different dynamic conditions and at the same time to react to different task requirements. An order scale with four points in the range from 0 to 3. "0" indicates the lowest functional level and "3" the highest functional level. The score of 19 predicts falls in the elderly and> 22 out of 24 in safe ambulances
Measured: 1st day
Dynamic Gait Index
The Dynamic Gait Index tests the participant's ability to maintain balance while walking under different dynamic conditions and at the same time to react to different task requirements. An order scale with four points in the range from 0 to 3. "0" indicates the lowest functional level and "3" the highest functional level. The score of 19 predicts falls in the elderly and> 22 out of 24 in safe ambulances falls is the dynamic gait index.Each object is marked at a scale of 0 to 3, 3 with standard and 0 showing led to problems DGI's 24 is the highest result possible
Measured: 2nd day
Secondary outcomes (2)
Berg Balance Scale
The Berg balance scale is an objective assessment of balance performance based on 14 items common to everyday activities. it is a 14-item scale that rates 0 (unable to perform) to 4 (normal performance) for each item. The total score is 56 points. Higher score higher balance ability.
Measured: 1st day
Time Up and Go Test
Time Up and Go Test is used determine fall risk and measure the progress of balance, sit to stand and walking, Cut of scores indicating risk of falls by Population Community Dwelling adults - 13.5 in seconds
Measured: 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 May 2021
- Primary completion1 Jul 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867486
- Sponsor's protocol ID
- REC-FSD-00262
- Status last verified
- Sep 2021
- First submitted
- 27 Apr 2021
- Last updated
- 14 Sep 2021
- 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 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Urdu Version of the Dynamic Gait Index in Pakistani Geriatric Population
- ClinicalTrials.gov ID
- NCT04867486
- Acronym / sponsor ID
- REC-FSD-00262
- Conditions
- Balance
- Keywords
- Dynamic gait index, balance, reliability, validity, geriatric population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 30 Apr 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.
In this study, Investigators will observe the reliability and validity of dynamic gait index in Urdu language in Pakistani geriatric population with balance impairments.
Detailed description
The aim of study is to translate and culturally adapt DGI into Urdu language and secondly to investigate the reliability and validity of DGI in geriatrics Pakistani population.This study will be cross sectional survey in which convenience sampling technique will be used to enroll participants as per pre-defined criteria.
The results of study will help to know the validity and reliability of DGI in Urdu version with balance impairments in geriatric population.The reliability of the scale will be checked through internal consistency and test-retest methods. Internal consistency will be analyzed with Cronbach's alpha value.Test-retest reliability will be assessed using an intraclass correlation coefficient with 60 patients
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly people, especially those of the advanced ages, suffer from coexistent disorders, many of which are chronically degenerative, falls and gait disorders are common issues. About one-third of all elderly people aged 65 as well as above fall at least once a year. Injury, physical impairments, morbidity, cognitive side effects, and even disability are all linked to fall because equilibrium and postural control are essential for the everyday work.
Key inclusion criteria (4 listed)
- Age at least 65 years
- Ability to walk a minimum of 6m with or without a walking Aid
- One or more falls in the last year or
- Observed balance impairment evaluated subjectively by a physical therapist during the initial training session (Time Up and Go test, Morse Fall Scale)
Key exclusion criteria (3 listed)
- Inability to understand or follow the instructions of the DGI
- Experience with the DGI in the last 6 months
- Acute illness or fracture in the lower extremities or knee/hip replacement within the last 3 months.
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
Dynamic Gait Index
Time frame: 1st day
The Dynamic Gait Index tests the participant's ability to maintain balance while walking under different dynamic conditions and at the same time to react to different task requirements. An order scale with four points in the range from 0 to 3. "0" indicates the lowest functional level and "3" the highest functional level. The score of 19 predicts falls in the elderly and> 22 out of 24 in safe ambulances
Dynamic Gait Index
Time frame: 2nd day
The Dynamic Gait Index tests the participant's ability to maintain balance while walking under different dynamic conditions and at the same time to react to different task requirements. An order scale with four points in the range from 0 to 3. "0" indicates the lowest functional level and "3" the highest functional level. The score of 19 predicts falls in the elderly and> 22 out of 24 in safe ambulances falls is the dynamic gait index.Each object is marked at a scale of 0 to 3, 3 with standard and 0 showing led to problems DGI's 24 is the highest result possible
2 secondary outcomes
Berg Balance Scale
Time frame: 1st day
Time Up and Go Test
Time frame: 1st day
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 14 Sep 2021.
- 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.
Muhammad Kashif study chair
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 Balance, 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 4 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: finished, as of the sponsor's last update on 14 Sep 2021. 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?
Dynamic Gait Index (time frame: 1st day). The study lists 2 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 Sep 2021.