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Trunk Control, Balance, Gait, Functional Mobility and Fear of Falling in People With Alzheimer's Disease

Primary Purpose

Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Balance
Trunk control
Gait
Functional mobility
Fear of falling
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Physical Therapy focused on measuring trunk control, balance, gait, functional mobility, fear of falling

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Clinical diagnosis of Alzheimer's disease according to the NINCDS/ARDRA diagnostic criteria by a neurologist.
  • Having a cognitive level between 18-23 points according to the Mini Mental Status Examination.
  • Must be able to walk independently with and/or without assistive device.

Exclusion Criteria

  • Having a history of cerebrovascular disease, epilepsy and brain tumor.
  • Having a cognitive level below 18 points according to the Mini Mental Status Examination.

Sites / Locations

  • Giresun University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alzheimer's disease

Healthy older adults

Arm Description

People with Alzheimer's disease who were diagnosed with Alzheimer's disease according to NINCDS/ARDRA diagnostic criteria by a neurologist and whose cognitive level was between 18-23 points according to Mini Mental State Examination.

33 healthy older adults with matching ages and gender.

Outcomes

Primary Outcome Measures

Trunk control
Trunk control was evaluated with Trunk Impairment Scale (TIS). TIS evaluates static sitting balance, dynamic sitting balance, and trunk coordination on a scale from 0 to 23 points, a higher score indicating a better performance.

Secondary Outcome Measures

Functional balance
Functional balance was evaluated with Berg Balance Scale (BBS). BBS consists of 14 functional tasks of increasing difficulty, each scored on a scale ranging from 0 to 4 (0: unable to perform the task; 4: task is performed independently). The maximum possible score is 56, indicating no identifiable balance difficulties.
Dynamic bilateral stance balance
Dynamic bilateral stance balance was evaluated with Functional Reach Test (FRT). FRT, a test of dynamic bilateral stance balance. This test measures the maximum distance that participants can reach forward with their dominant arm raised to 90 degrees without moving their feet, which were positioned 10 cm apart. The distance of additional reach from the starting position was recorded (in centimeters).
One leg standing balance
One leg standing balance was evaluated with One Leg Stance Test (OLST). OLST measures the time one is able to stand on one lower limb without support. This test is a clinical tool to assess postural steadiness in a static position by quantitative measurement. The participant was asked to stand on one leg for 30 seconds while the knee was in 90° flexion. Two measurements were made with a stopwatch and the best measurement score was recorded. The test was repeated for both sides.
Balance
Balance was evaluated with Five-Repeat Sit-and-Stand Test (5STS). 5STS required a straight-back armless chair of standard height (45cm) placed firmly against a wall. After performing an initial single chair stand with arms folded across the chest and feet flat on the floor, the time to complete 5 repeat chair stands was recorded in seconds. A stopwatch was provided to participants who used a suitable chair in their home for all home-based tests Measurements were repeated 3 times and the average duration was calculated as a patient score.
Gait
Gait was evaluated with Dynamic Gait Index (DGI). DGI has 8 items: walking, walking while changing speed, walking while turning the head horizontally and vertically, walking with pivot turn, walking over and around obstacles, and stair climbing. The scoring of the DGI is based on a 4-point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score indicates greater impairment in gait
Functional mobility
Functional mobility was evaluated with Timed Up and Go Test (TUG). TUG is a test of the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down. The stopwatch timing started when the participant's bottom left the chair and ended when the bottom made contact with the chair after the walk.
Fear of falling
Fear of falling was evaluated with the Falls Efficacy Scale-International (FES-I). FES-I is used to assess the level of concern about falls during 16 activities of daily living, ranging from basic to more demanding activities including social activities that may contribute to quality of life. It was administered as a self-report questionnaire. The level of concern for each item was scored on a 4-point scale (1: not at all, 2: somewhat, 3: quite a lot, 4: very), with the total score range being 16 to 64.

Full Information

First Posted
September 30, 2022
Last Updated
October 11, 2022
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT05576688
Brief Title
Trunk Control, Balance, Gait, Functional Mobility and Fear of Falling in People With Alzheimer's Disease
Official Title
Investigation of the Relationship Between Trunk Control and Balance, Gait, Functional Mobility and Fear of Falling in People With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of this study were to investigate the relationship between trunk control and balance, gait, functional mobility, and fear of falling in people with Alzheimer's disease and to compare trunk control, balance, gait, functional mobility, and fear of falling in people with Alzheimer's disease and healthy older adults. Balance, an essential motor skill necessary to perform both static and dynamic everyday activities with stability and security, is impaired in people with Alzheimer's disease when compared to cognitively preserved elderlies. Gait and functional mobility disorders are also observed in people with Alzheimer's disease from the early period of the disease. People with Alzheimer's disease tend to fall more often and are more seriously injured from falls than cognitively intact older adults. The annual incidence rate for falling is 60% to 80% for older adults with Alzheimer's disease, over twice the incidence of age-matched cognitively intact older adults. Trunk control is shown among the most important factors that ensure the balance and walking of the individual in different environments and conditions during functional activities. Optimal trunk control relies on adequate somatosensory, motor, and musculoskeletal systems, which are frequently compromised in people with Alzheimer's disease. For this reason, the investigators think that trunk control may be affected in people with Alzheimer's disease compared to healthy older adults and may be related to balance, gait, functional mobility and fear of falling.
Detailed Description
The study was carried out with the purpose of investigating the relationship between trunk control and balance, gait, functional mobility, and fear of falling in people with Alzheimer's disease and comparing trunk control, balance, gait, functional mobility, and fear of falling in people with Alzheimer's disease and healthy older adults. 35 people with Alzheimer's disease and 33 healthy older adults with matching ages and genders were included the study. Trunk control with Trunk Impairment Scale; balance with Berg Balance Scale, Functional Reach Test, One-Leg Standing Test and Five-Repeat Sit-and-Stand Test; gait with Dynamic Gait Index; functional mobility with Timed Up and Go Test; fear of falling with Falls Efficacy Scale-International were evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy
Keywords
trunk control, balance, gait, functional mobility, fear of falling

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer's disease
Arm Type
Experimental
Arm Description
People with Alzheimer's disease who were diagnosed with Alzheimer's disease according to NINCDS/ARDRA diagnostic criteria by a neurologist and whose cognitive level was between 18-23 points according to Mini Mental State Examination.
Arm Title
Healthy older adults
Arm Type
No Intervention
Arm Description
33 healthy older adults with matching ages and gender.
Intervention Type
Other
Intervention Name(s)
Balance
Intervention Description
Balance was evaluated with Berg Balance Scale (BBS), Functional Reach Test (FRT), One Leg Stance Test (OLST) and Five-Repeat Sit-and-Stand Test (5STS). BBS consists of 14 functional tasks of increasing difficulty, each scored on a scale ranging from 0 to 4. The maximum possible score is 56, indicating no identifiable balance difficulties. FRT measures the maximum distance that participants can reach forward with their dominant arm raised to 90 degrees without moving their feet, which were positioned 10 cm apart. OLST measures the time one is able to stand on one lower limb without support. The test was repeated for both sides. 5STS assesses the time it takes to get up and sit from the chair five times. Measurements were repeated 3 times and the average duration was calculated as a patient score.
Intervention Type
Other
Intervention Name(s)
Trunk control
Intervention Description
Trunk control was evaluated with Trunk Impairment Scale (TIS).TIS evaluates static sitting balance, dynamic sitting balance, and trunk coordination on a scale from 0 to 23 points, a higher score indicating a better performance.
Intervention Type
Other
Intervention Name(s)
Gait
Intervention Description
Gait was evaluated with Dynamic Gait Index (DGI). DGI has 8 items: walking, walking while changing speed, walking while turning the head horizontally and vertically, walking with pivot turn, walking over and around obstacles, and stair climbing. The scoring of the DGI is based on a 4-point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score indicates greater impairment in gait.
Intervention Type
Other
Intervention Name(s)
Functional mobility
Intervention Description
Functional mobility was evaluated with Timed Up and Go Test (TUG). TUG is a test of the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down. The stopwatch timing started when the participant's bottom left the chair and ended when the bottom made contact with the chair after the walk.
Intervention Type
Other
Intervention Name(s)
Fear of falling
Intervention Description
Fear of falling was evaluated with the Falls Efficacy Scale-International (FES-I). FES-I was used to assess the level of concern about falls during 16 activities of daily living, ranging from basic to more demanding activities including social activities that may contribute to quality of life. It was administered as a self-report questionnaire.
Primary Outcome Measure Information:
Title
Trunk control
Description
Trunk control was evaluated with Trunk Impairment Scale (TIS). TIS evaluates static sitting balance, dynamic sitting balance, and trunk coordination on a scale from 0 to 23 points, a higher score indicating a better performance.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Functional balance
Description
Functional balance was evaluated with Berg Balance Scale (BBS). BBS consists of 14 functional tasks of increasing difficulty, each scored on a scale ranging from 0 to 4 (0: unable to perform the task; 4: task is performed independently). The maximum possible score is 56, indicating no identifiable balance difficulties.
Time Frame
1 month
Title
Dynamic bilateral stance balance
Description
Dynamic bilateral stance balance was evaluated with Functional Reach Test (FRT). FRT, a test of dynamic bilateral stance balance. This test measures the maximum distance that participants can reach forward with their dominant arm raised to 90 degrees without moving their feet, which were positioned 10 cm apart. The distance of additional reach from the starting position was recorded (in centimeters).
Time Frame
1 month
Title
One leg standing balance
Description
One leg standing balance was evaluated with One Leg Stance Test (OLST). OLST measures the time one is able to stand on one lower limb without support. This test is a clinical tool to assess postural steadiness in a static position by quantitative measurement. The participant was asked to stand on one leg for 30 seconds while the knee was in 90° flexion. Two measurements were made with a stopwatch and the best measurement score was recorded. The test was repeated for both sides.
Time Frame
1 month
Title
Balance
Description
Balance was evaluated with Five-Repeat Sit-and-Stand Test (5STS). 5STS required a straight-back armless chair of standard height (45cm) placed firmly against a wall. After performing an initial single chair stand with arms folded across the chest and feet flat on the floor, the time to complete 5 repeat chair stands was recorded in seconds. A stopwatch was provided to participants who used a suitable chair in their home for all home-based tests Measurements were repeated 3 times and the average duration was calculated as a patient score.
Time Frame
1 month
Title
Gait
Description
Gait was evaluated with Dynamic Gait Index (DGI). DGI has 8 items: walking, walking while changing speed, walking while turning the head horizontally and vertically, walking with pivot turn, walking over and around obstacles, and stair climbing. The scoring of the DGI is based on a 4-point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score indicates greater impairment in gait
Time Frame
1 month
Title
Functional mobility
Description
Functional mobility was evaluated with Timed Up and Go Test (TUG). TUG is a test of the time required for an individual to stand up from a chair with armrests, walk 3 m, turn, walk back to the chair, and sit down. The stopwatch timing started when the participant's bottom left the chair and ended when the bottom made contact with the chair after the walk.
Time Frame
1 month
Title
Fear of falling
Description
Fear of falling was evaluated with the Falls Efficacy Scale-International (FES-I). FES-I is used to assess the level of concern about falls during 16 activities of daily living, ranging from basic to more demanding activities including social activities that may contribute to quality of life. It was administered as a self-report questionnaire. The level of concern for each item was scored on a 4-point scale (1: not at all, 2: somewhat, 3: quite a lot, 4: very), with the total score range being 16 to 64.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Clinical diagnosis of Alzheimer's disease according to the NINCDS/ARDRA diagnostic criteria by a neurologist. Having a cognitive level between 18-23 points according to the Mini Mental Status Examination. Must be able to walk independently with and/or without assistive device. Exclusion Criteria Having a history of cerebrovascular disease, epilepsy and brain tumor. Having a cognitive level below 18 points according to the Mini Mental Status Examination.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taskin Ozkan, Doctorate
Organizational Affiliation
Giresun University Vocational School of Health Services Therapy and Rehabilitation Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Giresun University
City
Giresun
ZIP/Postal Code
28200
Country
Turkey

12. IPD Sharing Statement

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Trunk Control, Balance, Gait, Functional Mobility and Fear of Falling in People With Alzheimer's Disease

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