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

Sponsor

Ankara Yildirim Beyazıt University (Other)

Overall Status

Completed

CT.gov ID

NCT05576688

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

11.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Therapy	Other: Balance Other: Trunk control Other: Gait Other: Functional mobility Other: Fear of falling	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

May 1, 2022

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alzheimer's disease 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.	Other: Balance 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. Other: 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. Other: 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. Other: 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. Other: Fear of falling 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.
No Intervention: Healthy older adults 33 healthy older adults with matching ages and gender.

Arm

Intervention/Treatment

Experimental: Alzheimer's disease

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.

Other: Balance

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.

Other: 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.

Other: 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.

Other: 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.

Other: Fear of falling

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.

No Intervention: Healthy older adults

33 healthy older adults with matching ages and gender.

Outcome Measures

Primary Outcome Measures

Trunk control [1 month]
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 [1 month]
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 [1 month]
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 [1 month]
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 [1 month]
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 [1 month]
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 [1 month]
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 [1 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.