Stroke Clinical Trial
— BEAMOfficial title:
Beam Walking to Assess Dynamic Balance in Health and Disease: A Protocol for the 'BEAM' Multi-center Observational Study
Verified date | May 2018 |
Source | University Medical Center Groningen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: Dynamic balance keeps the vertical projection of the center of mass within the base of support while the center of mass moves. The age-related decrease in dynamic balance is a risk factor for falls. Dynamic balance tests are used to predict the risks for falls and eventual falls but the psychometric properties of most tests assessing dynamic balance are unsatisfactory and comprise no actual loss of balance while walking. Objectives: Using beam walking distance as a measure of dynamic balance, we will determine the psychometric properties, lifespan and patient reference values, the relationship with selected 'dynamic balance tests', and the accuracy of beam walking distance to predict falls. Methods: This cross-sectional observational study will examine healthy adults in 7 decades (n=432) at 4 centers. Center 5 will examine patients (n=100) diagnosed with Parkinson's disease, multiple sclerosis, stroke, and balance disorders. At Test 1, all participants will be measured for demographics, medical history, grip and leg strength, short physical performance battery, static balance on a force platform, and dynamic balance using beam walking (4m-long, 4, 8, and 12 cm wide) under single (beam walking only) and dual task conditions (beam walking while concurrently performing an arithmetic task). In addition, cognitive function (global cognition, attention, executive function, processing speed, memory) will be assessed. Patients and healthy participants age 50+ will be additionally measured for fear of falling, history of falls, miniBESTest, functional reach on a force platform, timed up and go, and reactive balance. At Test 2, 7-10 days after Test 1, healthy adults young and age 50+ (n=40) will be re-tested for reliability of beam walking performance. All participants age 50+ will be re-called to report fear of falling and fall history 6 and 12 months after Test 1. Conclusion: The investigators expect to find that beam walking performance vis-à-vis the traditionally used balance outcomes predicts more accurately fall risks and falls.
Status | Not yet recruiting |
Enrollment | 432 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Volunteer participants included will be male and female adults aged over 20, in good health, balance, and mobility. Exclusion Criteria: - Positive answer to any of the following questions in a (phone) interview results in exclusion from the study: unable to walk 10-m independently; knee or hip joint replacements =6 months before enrollment; uncontrolled cardiovascular disease or angina; neuromuscular disease; diagnosed Parkinson's disease; multiple sclerosis; stroke; cancer therapy = 3 months before enrollment; severe asthma or chronic bronchitis; diagnosed diabetes with neuropathy, poor and uncorrected vision, and a score =27 on the Mini-Mental State Examination (MMSE). |
Country | Name | City | State |
---|---|---|---|
Brazil | School of Physical Education and Sport of Ribeirão Preto | São Paulo | |
Germany | University of Potsdam | Potsdam | |
Hungary | Somogy County Kaposi Mór Teaching Hospital | Kaposvár | |
Japan | Dokkyo Medical University | Mibu | |
Netherlands | University of Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen | Dokkyo Medical University, Somogy Megyei Kaposi Mór Teaching Hospital, University of Potsdam, University of Sao Paulo |
Brazil, Germany, Hungary, Japan, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | distance in balance beam walking under single and dual-task conditions | Outcomes are the sum of length traversed (3-5 trials, 4m each, 12m maximum), average velocity, number of steps, and average step length determined from video tape recordings (60Hz) made at 90° relative to the walking direction with full beam length in view using off-the-shelf HD video cameras (Kinovea software). | 2 hours | |
Secondary | Physical activity | Physical activity will be estimated by the international physical activity questionnaire in all participants | 10 minutes | |
Secondary | Fall history | Fall history will be determined by having participants age 50+ report falls for the previous 12 months ('Have you experienced a fall over the past 12 months? 'How severe was the most severe fall? (Hospitalization, fracture, nursing home admission).' Patients' hospital fall records will be also consulted if available. | 10 minutes | |
Secondary | Falls efficacy scale-international | Falls efficacy scale-international will determine in participants age 50+ the level of concern about falling during social and physical activities indoors and outdoors. 16-items are being asked on a 4-point Likert scale. The scores are added up to calculate a total score that ranges from 16 to 64. A higher score indicates a greater fear of falling. | 10 minutes | |
Secondary | Balance confidence | Balance confidence will be assessed with the Activities-specific Balance Confidence (ABC) Scale. The scale is in % from 0 (no confidence) to 100 (completely confident) | 15 minutes | |
Secondary | Mini-BESTest | Mini-BESTest identifies systems that control (dynamic) balance. | 20 minutes | |
Secondary | Mobility | Mobility will be measured in all participants by the Short Physical Performance Battery, a composite mobility test. | 20 minutes | |
Secondary | Static steady-state balance | Static steady-state balance will be assessed in all participants using the Romberg and Sharpened Romberg Tests while standing on a force platform with feet closed while holding both arms extended to the front with palms facing upwards and in tandem stance with eyes open and closed for 10s each task. | 10 minutes | |
Secondary | Proactive Balance | Proactive balance will be measured in all participants age 20-29 and 50+ by the functional reach test while standing on a force platform | 10 minutes | |
Secondary | Reactive balance | Reactive balance will be measured in all participants age 20-29 and 50+ by the push and release test | 10 minutes | |
Secondary | Upper extremity strength | Upper extremity strength will be measured in all participants by grip strength | 10 minutes | |
Secondary | Lower extremity strength | Lower extremity strength of the knee extensors will be measured in all participants in the seated position on a dynamometer or by a hand held dynamometer | 10 minutes | |
Secondary | Cognitive status | Cognitive status will be measured in all participants by the Digit Symbol Substitution Test | 5 minutes | |
Secondary | Global cognition | Global cognition will be measured in participants aged 50+ by the Mini Mental State Examination Test | 5 minutes | |
Secondary | Executive function | Executive function will be measured in participants aged 50+ by the phonemic fluency test | 5 minutes | |
Secondary | Attention | Attention will be measured in participants aged 50+ by the Stroop color-word test | 5 minutes | |
Secondary | Verbal memory span | Verbal memory span will be measured in participants aged 50+ by the Digit Span test | 10 minutes | |
Secondary | Visual memory span | Visual memory span will be measured in participants aged 50+ by the Visual Memory Span test | 10 minutes |
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