NCT07741513

Brief 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. 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. 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

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 22, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

1.6 years

First QC Date

July 22, 2026

Last Update Submit

July 31, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    6 months

  • 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.

    6 months

  • 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.

    6 months

  • 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).

    6 months

  • 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).

    6 months

  • 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.

    6 months

Secondary Outcomes (8)

  • Ability to stand up from the floor

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

  • Functional mobility

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

  • Functional lower-limb strength

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

  • Postural balance

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

  • Confidence in balance during daily activities

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

  • +3 more secondary outcomes

Study Arms (2)

Intervention group: balance workshops with a "getting up from the floor" module

EXPERIMENTAL

• 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.

Other: Balance WorkshopsOther: "getting up from the floor" module

Control group: balance workshops

ACTIVE COMPARATOR

Participants 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.

Other: Balance Workshops

Interventions

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.

Control group: balance workshopsIntervention group: balance workshops with a "getting up from the floor" module

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.

Intervention group: balance workshops with a "getting up from the floor" module

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Association KPAURA RHONE

Valence, 26000, France

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

August 3, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2029

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations