Effect of Sleeve Gastrostomy in Both Cognition and BalanceNCT05337176
Impact of Sleeve Gastrectomy on Balance and Cognitive Function
An observational study of Effect of Sleeve Gastrostomy in Both Cognition and Balance, run by Rawan Alwafi at 1 site in Saudi Arabia.
Trial summary
Purpose of the study: Purpose of study is to determine the effect of sleeve gastrectomy on balance and cognitive function in Saudi Arabia. Aim of study: To investigate if there is any change of balance and cognitive function disturbance after sleeve gastrectomy on participant. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Effect of Sleeve Gastrostomy in Both Cognition and Balance
- What is being tested?
- app-coo application
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2021to 5 Apr 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 20 to 60 years
- All sexes
- Adult
Study population: participants for gender (male and Female) , age ranged from 20 to 60 years old, were randomly involved After bariatric surgery from different regions across Saudi Arabia
Who may be able to join
- -
- The participant will be selected according to the following criteria:
- History of sleeve gastrectomy within 1 to 5 years.
- Their age between (20-60 years).
- Ability to walk without any assistive device.
- All participant should be able to understand all requested instructions
Who cannot join
- -
- The participant will be excluded if they have:
- Any cognitive disturbances.
- Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
- Gastrectomy operation less than 1year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Sleeve Gastrectomy on Balance and Cognitive Function: A Cross-sectional Study
Purpose of the study:
Purpose of study is to determine the effect of sleeve gastrectomy on balance and cognitive function in Saudi Arabia.
Read more
Aim of study:
To investigate if there is any change of balance and cognitive function disturbance after sleeve gastrectomy on participant.
Research hypothesis:
Sleeve gastrectomy have no impact on balance and cognitive function.
Inclusion criteria:
The participant will be selected according to the following criteria: 1.History of sleeve gastrectomy within 1 to 5 years.
- Their age between (20-60 years). 3.Ability to walk without any assistive device. 4.All participant should be able to understand all requested instructions
Exclusion criteria:
The participant will be excluded if they have:
- Any cognitive disturbances.
- Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
- Gastrectomy operation less than 1year.
- Pregnancy.
Material:
- Introduction survey (willingness of participant) to recruit sittable participant.
- Assessment form survey to collected data and result (include MOCA and App-coo application)
- Being tested
- app-coo application
- Keywords
- sleeve gastrectomy, Balance, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
app-coo applicationOther
Also called MoCA (Montreal cognitive assessment)
The Montreal Cognitive Assessment (MoCA) is a measure designed specifically for detecting mental cognitive impairment(MCI) APP-Coo-Balance-Test can assess the oscillation of the trunk in different static positions: "Feet Together", "On a Broad Base" (medial malleoli 30 cm apart) , and during the gait "Dynamic"(Arcuria et al., 2020).
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of sleeve gastrectomy on cognition
by using (MoCA) and see the result
Measured: 2 to 3 month
Secondary outcomes (1)
impact of sleeve gastrectomy on balance
by using a new application called : app-coo balance test
Measured: 2 to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Dec 2021
- Primary completion1 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Sleeve Gastrostomy in Both Cognition and 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawan Alwafi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rawan Alwafi, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337176
- Sponsor's protocol ID
- UmmAlQura
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- 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 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleeve Gastrectomy on Balance and Cognitive Function: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05337176
- Acronym / sponsor ID
- UmmAlQura
- Keywords
- sleeve gastrectomy, Balance, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rawan AlwafiUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 20 Apr 2022 (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.
Purpose of the study:
Purpose of study is to determine the effect of sleeve gastrectomy on balance and cognitive function in Saudi Arabia.
Aim of study:
To investigate if there is any change of balance and cognitive function disturbance after sleeve gastrectomy on participant.
Research hypothesis:
Sleeve gastrectomy have no impact on balance and cognitive function.
Inclusion criteria:
The participant will be selected according to the following criteria: 1.History of sleeve gastrectomy within 1 to 5 years.
- Their age between (20-60 years). 3.Ability to walk without any assistive device. 4.All participant should be able to understand all requested instructions
Exclusion criteria:
The participant will be excluded if they have:
- Any cognitive disturbances.
- Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
- Gastrectomy operation less than 1year.
- Pregnancy.
Material:
- Introduction survey (willingness of participant) to recruit sittable participant.
- Assessment form survey to collected data and result (include MOCA and App-coo application)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- participants for gender (male and Female) , age ranged from 20 to 60 years old, were randomly involved After bariatric surgery from different regions across Saudi Arabia
Key inclusion criteria (6 listed)
- -
- History of sleeve gastrectomy within 1 to 5 years.
- Their age between (20-60 years).
- Ability to walk without any assistive device.
- All participant should be able to understand all requested instructions
Key exclusion criteria (5 listed)
- -
- Any cognitive disturbances.
- Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
- Gastrectomy operation less than 1year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| app-coo applicationAlso: MoCA (Montreal cognitive assessment)The Montreal Cognitive Assessment (MoCA) is a measure designed specifically for detecting mental cognitive impairment(MCI) APP-Coo-Balance-Test can assess the oscillation of the trunk in different static positions: "Feet Together", "On a Broad Base" (medial malleoli 30 cm apart) , and during the gait "Dynamic"(Arcuria et al., 2020). | Other | – |
Primary outcome
impact of sleeve gastrectomy on cognition
Time frame: 2 to 3 month
by using (MoCA) and see the result
1 secondary outcome
impact of sleeve gastrectomy on balance
Time frame: 2 to 3 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 20 Apr 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Effect of Sleeve Gastrostomy in Both Cognition and Balance, run by Rawan Alwafi at 1 site in Saudi Arabia.
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 6 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 20 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 Saudi Arabia. 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?
impact of sleeve gastrectomy on cognition (time frame: 2 to 3 month). 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 20 Apr 2022; AzTrials last refreshed its copy on 6 Nov 2026.