Trunk Control, Balance, Gait, Functional Mobility and Fear of Falling in People With Alzheimer's Disease
Investigation of the Relationship Between Trunk Control and Balance, Gait, Functional Mobility and Fear of Falling in People With Alzheimer's Disease
1 other identifier
interventional
68
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 30, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedOctober 13, 2022
October 1, 2022
5 months
September 30, 2022
October 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month
Secondary Outcomes (7)
Functional balance
1 month
Dynamic bilateral stance balance
1 month
One leg standing balance
1 month
Balance
1 month
Gait
1 month
- +2 more secondary outcomes
Study Arms (2)
Alzheimer's disease
EXPERIMENTALPeople 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.
Healthy older adults
NO INTERVENTION33 healthy older adults with matching ages and gender.
Interventions
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 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 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 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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Having a history of cerebrovascular disease, epilepsy and brain tumor.
- Having a cognitive level below 18 points according to the Mini Mental Status Examination.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Giresun University
Giresun, 28200, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Taskin Ozkan, Doctorate
Giresun University Vocational School of Health Services Therapy and Rehabilitation Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2022
First Posted
October 12, 2022
Study Start
December 1, 2021
Primary Completion
May 1, 2022
Study Completion
June 1, 2022
Last Updated
October 13, 2022
Record last verified: 2022-10