Impact of Sleeve Gastrectomy on Balance and Cognitive Function

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.

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.

2. 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:

1. Any cognitive disturbances.
2. Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
3. Gastrectomy operation less than 1year.
4. Pregnancy.

Material:

1. Introduction survey (willingness of participant) to recruit sittable participant.
2. Assessment form survey to collected data and result (include MOCA and App-coo application)

Study Overview

• Status: Completed
• Conditions: Effect of Sleeve Gastrostomy in Both Cognition and Balance
• Intervention / Treatment: Other: app-coo application

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Saudi Arabia
  • Mecca, Saudi Arabia, 24144
    • Rawan Alwafi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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

Description

Inclusion Criteria:

-

The participant will be selected according to the following criteria:

1. History of sleeve gastrectomy within 1 to 5 years.
2. 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:

1. Any cognitive disturbances.
2. Disease that may affect balance (Spinal stenosis, peripheral polyneuropathy, vestibular impairment).
3. Gastrectomy operation less than 1year.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of sleeve gastrectomy on cognition	by using (MoCA) and see the result	2 to 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of sleeve gastrectomy on balance	by using a new application called : app-coo balance test	2 to 3 months

Collaborators and Investigators

• Sponsor: Rawan Alwafi

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 5, 2022

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Balance; cognition; sleeve gastrectomy
• Other Study ID Numbers: UmmAlQura

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No