Impact of Sleeve Gastrectomy on Balance and Cognitive Function

Completed

• Conditions: Effect of Sleeve Gastrostomy in Both Cognition and Balance

• Registration Number: NCT05337176
• Lead Sponsor: Rawan Alwafi

Brief 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.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-05
• Study First Submitted: 2022-04-13
• Study First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Study First Posted: 2022-04-20
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
impact of sleeve gastrectomy on cognition	2 to 3 month	by using (MoCA) and see the result

Secondary Outcome Measures

Name	Time	Method
impact of sleeve gastrectomy on balance	2 to 3 months	by using a new application called : app-coo balance test

Trial Locations

Locations (1)

Rawan Alwafi; 🇸🇦 Mecca, Saudi Arabia