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Balance Control in ElderlyNCT07741513

Balance Workshops Focusing on Learning to Stand Up From the Floor for Older Adults Living at Home: A Pilot Study Sol'Up

A study testing Balance Workshops and "getting up from the floor" module in people with Balance Control in Elderly and Fall Prevention, run by Centre Hospitalier Emile Roux at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Falls among older adults are a major public health issue, accounting for approximately 2 million incidents annually in France, resulting in more than 10,000 deaths and 130,000 hospitalizations. Their cost is estimated at nearly 2 billion euros per year and is expected to rise as the population ages. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Balance Control in Elderly, Fall Prevention
What is being tested?
Balance Workshops and "getting up from the floor" module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFrance
Study dates
15 Sep 2026to 31 Mar 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • People over the age of 65
  • Able to walk 100 m independently, with or without a walking aid (1 cane or 1 crutch)
  • Individuals who have fallen at least once in the past 12 months
  • Individuals who feel unsteady while standing or walking
  • Individuals who express a fear of falling
  • Individuals enrolled in the social security system or a similar program
  • Individuals who have been informed and have given their written consent to participate in the study

Who cannot join

  • Refusal to participate in the study
  • Individuals who walk with two canes or a walker, or who are unable to walk
  • Medical contraindications to physical activity (cardiac conditions, acute illness, uncompensated vestibular disorder).
  • Major cognitive impairment or dementia preventing active participation.
  • Individuals with other contraindications, at the investigator's discretion
  • Recent orthopedic surgery (<3 months).
  • Major uncompensated sensory impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Association KPAURA RHONE

    Valence, 26000

    Recruiting

Other trials in France

About this study

Official title: Balance Workshops Focusing on Learning to Stand Up From the Floor for Older Adults Living at Home: A Pilot Study - Sol'Up

Falls among older adults are a major public health issue, accounting for approximately 2 million incidents annually in France, resulting in more than 10,000 deaths and 130,000 hospitalizations. Their cost is estimated at nearly 2 billion euros per year and is expected to rise as the population ages.

Falls result from multiple factors, including biological, behavioral, and environmental factors, with balance and gait disorders playing a central role. Their consequences include loss of independence, restricted activity, and fear of falling.

Read more

The ability to get back up from the ground after a fall is still largely overlooked. Yet up to two-thirds of older adults who have fallen are unable to get up on their own, exposing them to serious complications and an increased risk of further falls. This skill remains under-assessed and under-trained.

Physical activity-particularly programs combining balance, muscle strengthening, and functional training-can reduce the risk of falling by approximately 20 to 30 percent. Balance workshops are widely used for this purpose. However, these interventions primarily focus on fall prevention and rarely address fall management, particularly the ability to get up from the floor. Specific interventions targeting this skill are still underdeveloped, with mixed results.

The integration of structured training in getting up from the floor into balance workshops

Read the detailed description

The primary objective of this study is to explore the feasibility and acceptability of integrating a soil survey training module into a balance workshop program for older adults living at home.

The secondary objectives of this study are to explore the potential effects of the program on certain functional and psychosocial dimensions among participants, by conducting an exploratory comparison between the intervention group and the control group.

The study will aim to assess:

  • the ability to get up from the floor;
  • functional mobility;
  • functional strength of the lower limbs;
  • postural balance;
  • confidence in balance during daily activities;
  • perceived self-efficacy for getting up from the floor;
  • level of physical activity;
  • the number of falls The feasibility of the intervention will be assessed based on the fidelity of its implementation: adherence to the content, the instructional progression, and the duration of the scheduled sessions. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

The acceptability of the intervention will be assessed based on the following factors:

  • Participants' satisfaction with the program, as measured by a satisfaction questionnaire administered at the end of the intervention.
  • Physical therapists' satisfaction with the program, as measured by a satisfaction questionnaire administered at the end of the intervention.
  • Program adherence, assessed by the session attendance rate (number of sessions attended relative to the total number of sessions offered) as well as the dropout rate during the program.

The secondary outcome measures aim to explore the potential impact of the intervention by comparing the intervention group and the control group. Measurements will be taken at the beginning of the program (T0) and at the end (T1) regarding:

  • Ability to stand up from the floor, assessed using a standardized floor-to-standing test, which evaluates the level of assistance required (0: cannot stand up, 1: with assistance, 2: without assistance) and the time required to stand up.
  • Functional mobility, assessed using the Timed Up and Go (TUG) test:
  • Functional strength of the lower limbs, assessed using the Five-Time Sit-to-Stand Test (FTSST)
  • Postural balance, assessed using the Romberg test, the tandem stance test, and the single-leg stance test.
  • Confidence in balance during daily activities (Activities-specific Balance Confidence Scale (ABC))
  • Perceived self-efficacy for getting up from the floor, assessed via a direct question (scale from 0 to 10).
  • Level of physical activity, assessed using a validated self-administered questionnaire (International Physical Activity Questionnaire - Short Form, IPAQ-SF).
  • Number of falls and circumstances

The criteria assessed via questionnaire (balance confidence during daily activities, perceived self-efficacy for getting up from the floor, level of physical activity, number of falls) will also be assessed by telephone 12 weeks after the intervention (T2).

Being tested
Balance Workshops, "getting up from the floor" module

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Balance WorkshopsOther

    Participants take part in the standard program, which includes one-hour group sessions designed to improve balance, mobility, coordination, muscle strength, confidence in moving around, and fall-prevention behaviors.

    The sessions include:

    • static and dynamic balance exercises;
    • muscle-strengthening exercises;
    • coordination and dual-task exercises;
    • joint mobility exercises;
    • educational sessions on physical activity, the environment, nutrition, and fall prevention;
    • discussion and wrap-up sessions to identify simple actions participants can take between sessions.
  • "getting up from the floor" moduleOther

    This 20 minutes module includes a safe progression covering:

    • lower-body mobility, particularly the ankles, knees, and hips;
    • weight shifts;
    • gradual transitions to the floor;
    • exercises in intermediate positions: lunge, knight's stance, all fours;
    • strategies for turning and moving on the floor;
    • learning to transition from the floor to a standing position;
    • identifying secure points of support;
    • managing apprehension;
    • applying what has been learned to everyday situations. Progression is tailored to each participant's level. Moving to the floor is never required. In cases of apprehension, pain, functional limitations, or identified risks, the physical therapist suggests adaptations: exercises with support, use of a stable chair, partial exercises, movement simulation, or identifying possible steps without fully lowering oneself to the floor.
Study groups in NCT07741513
Study groupRoleWhat they receive
Intervention group: balance workshops with a "getting up from the floor" moduleExperimental• Intervention group: balance workshops with a "ground scanning" module Participants in the intervention group take part in the same core set of workshops, with the addition of a specific module dedicated to learning ground scanning. To ensure that the total session duration remains the same for both groups, certain sequences of the standard program are adapted or replaced by a module lasting approximately 20 minutes that focuses on getting up from the floor.
Receives: Other: Balance Workshops; Other: "getting up from the floor" module
Control group: balance workshopsActive comparatorParticipants in the control group take part in the standard program, which includes one-hour group sessions designed to improve balance, mobility, coordination, muscle strength, confidence in moving around, and fall-prevention behaviors.
Receives: Other: Balance Workshops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of the intervention

    The feasibility of the intervention will be assessed based on the fidelity of its implementation: adherence to the content. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

    Measured: 6 months

  2. Feasibility of the intervention

    The feasibility of the intervention will be assessed based on the fidelity of its implementation: the pedagogical progression. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

    Measured: 6 months

  3. Feasibility of the intervention

    The feasibility of the intervention will be assessed based on the fidelity of its implementation: the duration of the scheduled sessions. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

    Measured: 6 months

  4. Acceptability of the intervention

    The acceptability of the intervention will be assessed based on the following factors:

    • Participants' satisfaction with the program, measured using a satisfaction questionnaire administered at the end of the intervention.

    The satisfaction survey for participants in the control group alternates between multiple-choice questions (to assess overall satisfaction, sense of safety, trust built, and organization) and open-ended questions (to gather their personal feedback on the benefits, challenges they faced, and areas for improvement).

    The satisfaction survey for participants in the intervention group alternates between multiple-choice questions (to assess overall satisfaction, organization, sense of safety, and confidence regarding falls) and open-ended questions (to gather personal impressions on benefits, challenges, and areas for improvement).

    Measured: 6 months

  5. Acceptability of the intervention

    The acceptability of the intervention will be assessed based on the following factors:

    • Physical therapists' satisfaction with the program, measured using a satisfaction questionnaire administered at the end of the intervention.

    The questionnaire for physical therapists in the control group alternates between multiple-choice questions (to assess the module's usefulness, satisfaction, ease of use, and relevance) and open-ended questions (to gather feedback, identify difficulties observed, and collect suggested adaptations from the instructor).

    The questionnaire for physical therapists in the intervention group combines multiple-choice questions (to assess the time spent, progress, ease of implementation, and relevance of the module) and open-ended questions (to gather feedback on participants' reactions, challenges, adjustments made, and areas for improvement).

    Measured: 6 months

  6. Acceptability of the intervention

    The acceptability of the intervention will be assessed based on the following factors:

    • Program adherence, assessed by the attendance rate (number of sessions attended relative to the total number of sessions offered) as well as the dropout rate during the program.

    Measured: 6 months

Secondary outcomes (8)
  1. Ability to stand up from the floor

    Ability to get up from the floor, assessed using a standardized floor-to-standing test, which allows for an evaluation of the level of assistance required (0: cannot get up, 1: with assistance, 2: without assistance) and the time required to get up.

    The floor-to-standing test will be used to assess the functional ability to get up after a fall. Participants will be asked to lie down on the floor in a standardized position and then get up as quickly as possible, without assistance, according to the instructions. The time taken to get up will be recorded, along with the strategy used (support, external aids). This test is considered a relevant indicator of impaired health, fall risk, and fall severity

    Measured: at the beginning of the program (T0) and at the end (T1)

  2. Functional mobility

    Functional mobility, assessed using the Timed Up and Go (TUG) test. The Timed Up and Go test measures basic functional mobility, including the ability to stand up, walk, turn around, and sit back down. The total time in seconds will be recorded.

    Measured: at the beginning of the program (T0) and at the end (T1)

  3. Functional lower-limb strength

    Functional strength of the lower limbs, assessed using the Five-Time Sit-to-Stand Test.

    The Five-Time Sit-to-Stand Test (FTSST) will be administered to assess lower-limb strength and functional mobility. Participants will be asked to stand up and sit down on a chair five times as quickly as possible, with their arms crossed over their chest. The total time required to complete the task will be recorded.

    Measured: at the beginning of the program (T0) and at the end (T1)

  4. Postural balance

    Postural balance: Static balance will be assessed using the Romberg test, the tandem stance test, and the single-leg stance test.

    For the Romberg test, participants stand with their feet together and arms at their sides, maintaining the position for up to 20 seconds-first with their eyes open, then with their eyes closed, and finally with their eyes open and their head tilted back.

    For the tandem stance test, participants stand with one foot directly in front of the other, heel to toe, for up to 20 seconds. Performance will be recorded separately for the right-foot-forward and left-foot-forward positions For the single-leg balance test, participants must stand on one leg without support, with the non-weight-bearing foot positioned at calf height without touching the leg. The time spent maintaining balance, up to 20 seconds, will be recorded for each leg.

    Measured: at the beginning of the program (T0) and at the end (T1)

  5. Confidence in balance during daily activities

    Confidence in balance during daily activities (Activities-specific Balance Confidence Scale, ABC) The Activities-specific Balance Confidence (ABC) Scale is used to assess participants' confidence in their ability to maintain balance during various activities of daily living. It consists of 16 items scored from 0% (no confidence) to 100% (complete confidence). The total score is the average of the item scores; a low score is associated with an increased risk of falls and activity limitations. The ABC scale is more sensitive to change than the Falls Efficacy Scale, making it more suitable for detecting a decline in balance confidence among older adults with higher levels of functioning.

    Measured: at the beginning of the program (T0) and at the end (T1)

  6. Perceived self-efficacy for getting up from the floor

    Perceived self-efficacy for getting up from the floor, assessed using a direct question (scale from 0 to 10).

    "I am confident in my ability to get up from the floor while lying on my back, on my own." Based on the general self-efficacy scale and the confidence survey, we will ask patients to rate their level of confidence in their ability to get up from the floor using a numerical scale from 0 to 10 (0 = I am not confident and 10 = I am very confident).

    Measured: at the beginning of the program (T0) and at the end (T1)

  7. Level of physical activity

    Perceived self-efficacy for getting up from the floor, assessed using a direct question (scale from 0 to 10).

    "I am confident in my ability to get up from the floor while lying on my back, on my own." Based on the general self-efficacy scale and the confidence survey, we will ask patients to rate their level of confidence in their ability to get up from the floor using a numerical scale from 0 to 10 (0 = I am not confident and 10 = I am very confident).

    Measured: at the beginning of the program (T0) and at the end (T1)

  8. Number of falls

    Number of falls (over the past 3 months) and circumstances. The number of falls will also be assessed 3 months after the 12-week mark following the intervention (T2) via a telephone interview.

    Measured: at the beginning of the program (T0) and at the end (T1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start15 Sep 2026
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07741513
Sponsor's protocol ID
RIPH2-BIGEARD-SOLUP
Other IDs
2026-A01178-43
Status last verified
Sep 2026
First submitted
22 Jul 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Balance Workshops and "getting up from the floor" module in people with Balance Control in Elderly and Fall Prevention, run by Centre Hospitalier Emile Roux at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christine BIGEARD (00 33 4 78 24 09 00, c.bigeard.kpaura@formationprevention.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the intervention (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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