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Completed

NCT Number: NCT05576688

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

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.

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Key information

Conditions

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Giresun University

Giresun, 28200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

balance

Other

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.

Trunk control

Other

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.

Gait

Other

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

Other

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

Other

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 outcomes

  1. Trunk control

    Time frame: 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 outcomes

  1. Functional balance

    Time frame: 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.

  2. Dynamic bilateral stance balance

    Time frame: 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).

  3. One leg standing balance

    Time frame: 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.

  4. Balance

    Time frame: 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.

  5. Gait

    Time frame: 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

  6. Functional mobility

    Time frame: 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.

  7. Fear of falling

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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