- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06908317
Teaching the Getting Up From the Floor Among Long-Term Care Facility Residents
Backward Chaining Method for Teaching the Getting Up From the Floor Among Long-Term Care Facility Residents
The aim of this study is to determine the effect of teaching the getting up from the floor using the Backward Chaining Method on functional mobility, muscle strength, fear of falling, and life-space mobility among among long-term care facility residents.
Methods: Randomized controlled trial of a teaching the getting up from the floor using the Backward Chaining Method for older people living in long-term care facility. The assessment of primary and secondary outcomes takes place in all subjects upon entry to the study (pre-test) by blinded assessors and after the 20-session intervention (post-test). After baseline assessments is completed, participants will be randomly allocated to intervention or control groups using stratified randomization based on the use of walking aids and baseline values of FES-I.
The BCM sessions will be provided in a community room situated in the nursing home and will be led by a physiotherapist with extensive experience in geriatric physiotherapy with assistance of 2 physiotherapist student.
Only stable chairs provided for supporting and safety, wedge pillows, and training mats are required during practicing.
Expected results Improvement in functional mobility of the IG Improvement in lower and upper limb muscle strength Improvement in fall efficacy Improvement in life-space mobility
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Budapest, Hungary
- Semmelweis University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• aged 65 years or older,
- living in the nursing home for at least 2 months,
- being able to walk at least 6 meters with or without walking aids
Exclusion Criteria:
• being physically unable to be taught how to get up from the floor.
- lower limb endoprosthesis implanted within 6 months
- severe pain (VAS> 7/10)
- cognitively unable to co-operate (based on psychiatrist's judgement)
- planned moving away from the nursing home during the study period.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
Practicing in getting up from the floor is taught with backward chaning method, three times per week for 7 weeks plus usual care provided at the nursing home.
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Each session lasts for 40 minutes starting with a five minutes warming-up including flexibility exercises and ends with a five minutes cooling-down consisting of stretching and breathing exercises. Warming-up is followed by the practicing of getting up floor taught with BMC involving the following 7 steps: Step 1: descending from a standing position to half kneeling on a wedge pillow. Step 2: descending from a standing position to half kneeling on the floor. Step 3: Like step 2, then descending both knees to the floor into a high kneeling position. Step 4: Like step 3, then descending both hands to the floor one at a time, to come to a prone kneeling position. Step 5: Like step 4, then descending of the body to half sitting. A pillow can be positioned under the hip to soften the floor surface. Step 6: Like step 5, then descending of the body to side lying position. Step 7: Like step 6, then turning from side-lying to supine |
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No Intervention: usual care group
Practicing in only usual care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go test
Time Frame: Baseline and at the end of the 7-week intervention period
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A test to measure the time (in seconds) it takes for the participant to stand up from a standard armchair (approximate seat height 46 cm; arm height 65 cm), walk to a cone 3 m from the chair, turn around, walk back to the chair and sit down again. Instruction for the participants is given as follows "walk at a comfortable and safe pace". Wearing their usual footwear, using their usual walking aids, and supporting themselves on the arm of a chair to stand up are allowed/permitted, but physically assistance is not given for them. After a trial to familiarise the test, two successive performances are measured and the average of these is used the analyses. If necessary, a 30-second rest is provided between tests. |
Baseline and at the end of the 7-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
grip-strength
Time Frame: Baseline and at the end of the 7-week intervention period
|
A test to assess overall muscle strength because this test strongly correlates with the overall muscle strength.
The grip-strength will be measured by Kern MAP 40K1 dynamometer and measured in kilogram.
This test will be administered in a sitting position and by taking the average of two consecutive measures in the dominant hand
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Baseline and at the end of the 7-week intervention period
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Fall Efficacy Scale-International (FES-I)
Time Frame: Baseline and at the end of the 7-week intervention period
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A test to assess fear of falling.
With its seven items, this scale asks how concerned the elderly person is about a possible fall during frequent activities of daily living.
The answer is marked on a scale of four: 1=not at all concerned; 2=somewhat concerned; 3=fairly concerned; 4=very concerned.
The total score can vary from 7 to 28 points with higher score indicating higher level of concern for falling
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Baseline and at the end of the 7-week intervention period
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Nursing Home Life-Space Diameter (NHLSD)
Time Frame: Baseline and at the end of the 7-week intervention period
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A test to assess life-space mobility.
It will be completed with the assistance of the nursing home staff based on the resident's movement during the previous 2 weeks.
This measurement evaluates the extent of the resident's movement (diameter): (1) within resident's room, (2) within unit, (3) outside unit, and (4) outside the facility; and frequency of movement: (0) never, (1) less than weekly, (2) at least weekly, (3) > 2 times/week, (4) 1-3 times/day, and (5) > 3 times/ day.
Total NHLSD scores were calculated as 1(diameter 1 × frequency 1) + 2(diameter 2 × frequency 2) + 3(diameter 3 × frequency 3) + 4(diameter 4 × frequency 4).
The score ranges from 0 to 50, 0 indicating being bedbound and 50 indicating leaving the facility daily.
The total scores marks the area in which the person moves around.
The total score ranges from 0 to 50, 0 indicating being bedbound and 50 indicating leaving the facility daily
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Baseline and at the end of the 7-week intervention period
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independence of mobility
Time Frame: Baseline and at the end of the 7-week intervention period
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During using the Nursing Home Life-Space Diameter (NHLSD), besides distance and frequency, the human assistance for mobility is scored on a two-point scale (0 = dependent, 1 = independent).
If movement is performed without human assistance, score of each item is multiplyed by 2. This another total score incorporates mobility independence into the total score and thus reflects not only distance and frequency but also dependence on human assistance for mobility.
In this case the maximum score, NHLSD-dependence, is 100 points
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Baseline and at the end of the 7-week intervention period
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Number of falling
Time Frame: During the 7-week intervention period
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Falls will be recorded to measure adverse events.
It will be by nursing home staff throughout the intervention period.
They will be provided with a pre-designed diary and asked to record each day if any participants will have fallen.
The diaries will be collected weekly by the assessor physiotherapists.
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During the 7-week intervention period
|
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30-second Sit to Stand Test
Time Frame: Baseline and at the end of the 7-week intervention period
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A test to assess the functional lower limb muscle strength.
This test counts the sit-to-stands completed in 30 seconds by the participant from a chair (approximate seat height of 46 cm), with arms folded across the chest.
The instruction to the participants is to " stand-up completely and sit down as quickly as possible".
The digital stop-watch is started when begin on the command "go".
Before timing, the participants is asked to perform one sit-to-stand.
During testing, the completion of each correct stand is silently counted by the assessor to ensure for the participant his/her own correct performance.
Incorrectly executed stands are not counted.
At the end of 30-second test period, stand more than halfway up is counted as a full stand.
If the participant could not perform a single sit-to-stand in a standard way, they are scored 0. During testing participants wear their regular footwear.
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Baseline and at the end of the 7-week intervention period
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SE RKEB: 24/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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