NCT06908317

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 3, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

March 27, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

get up from the floorbackward chaining methodfall preventionlong-term care facility

Outcome Measures

Primary Outcomes (1)

  • Timed Up and Go test

    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 Outcomes (6)

  • 30-second Sit to Stand Test

    Baseline and at the end of the 7-week intervention period

  • grip-strength

    Baseline and at the end of the 7-week intervention period

  • Fall Efficacy Scale-International (FES-I)

    Baseline and at the end of the 7-week intervention period

  • Nursing Home Life-Space Diameter (NHLSD)

    Baseline and at the end of the 7-week intervention period

  • independence of mobility

    Baseline and at the end of the 7-week intervention period

  • +1 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Other: floor rise training using backward chaining method

usual care group

NO INTERVENTION

Practicing in only usual care

Interventions

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

intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Semmelweis University

Budapest, Hungary

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
college professor

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 3, 2025

Study Start

April 14, 2025

Primary Completion

October 17, 2025

Study Completion

October 17, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication.

Locations