Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk )
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- Changes in the spatiotemporal gait parameters between V1 and V3 : walking speed Spatiotemporal gait parameters as measured using GAITRite®
Study Overview
Brief Summary
Falls are a health issue that is both common among older adults (affecting 1 in 2 people each year after age 80) and serious due to their traumatic, psychological, and functionally disabling complications. The international literature shows that it is possible to prevent recurrent falls by addressing the risk factors for falls, particularly by combating a sedentary lifestyle and deconditioning through regular standing and mobility exercises as part of a rehabilitation program. As part of France's major national plan to prevent falls among older adults, and at a time when medicine is becoming increasingly personalized, prescribing a digitally assisted self-rehabilitation program for people over 65 following a fall could enable as many people as possible to benefit from rehabilitation that boosts their motivation and reduces the time spent by healthcare professionals, while ensuring high-quality follow-up care.
LNA Santé, in collaboration with the Angers and Nantes University Hospitals, has developed a personalized, digitally assisted fall prevention program (the Stand'hop app) comprising three types of activities: tailored physical exercises, structured lifestyle advice, and an objective measurement of the patient's physical activity. Before moving forward with a larger-scale clinical trial to evaluate the effectiveness of this personalized, digitally assisted fall prevention program, the present study DigiWalk aims to describe changes in walking performance over 7 weeks among older adults who have experienced falls, when the program is used as an adjunct to standard care, compared to changes observed in older adults who have experienced falls and receive only standard care.
Detailed Description
The main objective is to compare changes in spatiotemporal gait parameters, after 7 weeks of intervention, in :
- Elderly fallers with a digitally assisted self-rehabilitation program in addition to standard care
- Elderly fallers with standard rehabilitation care
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 65 and older Fall at least once in the previous 3 months , requiring rehabilitation care from a physical therapist
- •Signed informed consent or consent from a third party (trusted individual, family member, or close relative)
- •Individuals physically capable of following a rehabilitation program (standard care, with or without digital assistance) and of wearing a watch
- •Individuals capable of following a self-rehabilitation program as well as the study procedures independently or with the assistance of a caregiver if needed
- •Patients enrolled in or covered by a social security program
Exclusion Criteria
- •A person deprived of liberty by an administrative or judicial decision, a person undergoing involuntary psychiatric treatment, or an adult subject to a legal protective measure
- •Contraindications to rehabilitation programs offered following a fall (standard care, with or without digital assistance)
Arms & Interventions
Intervention Group
Intervention: PFPP Group (Other)
Control Group
Intervention: Control Group (Other)
Outcomes
Primary Outcomes
Changes in the spatiotemporal gait parameters between V1 and V3 : walking speed Spatiotemporal gait parameters as measured using GAITRite®
Time Frame: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®
Time Frame: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
Changes in the spatiotemporal gait parameters between V1 and V3 : Percentage of double support time Spatiotemporal gait parameters as measured using GAITRite®
Time Frame: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
Changes in the spatiotemporal gait parameters between V1 and V3 : Coefficient of variation of stride time Spatiotemporal gait parameters as measured using GAITRite®
Time Frame: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
Walking speed (km/h).
Time Frame: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
Walking speed (km/h). Spatiotemporal gait parameters as measured using GAITRite®
Secondary Outcomes
- Number of falls(baseline, 3 weeks and 7 weeks (8 maximum))
- Gait stability measured by a smartwatch paired with an iPhone (in percentage)(1 week and 7 weeks (8 weeks max))
- Time spent performing activities involving whole-body movements (minutes), measured by a smartwatch paired with an iPhone.(1 week and 7 weeks (8 weeks max))
- Number of hours per day during which the participant stood and moved for at least one minute per hour. Measured by a smartwatch paired with an iPhone.(1 week and 7 weeks (8 weeks max))
- Time spent standing (minutes), measured by a smartwatch paired with an iPhone.(1 week and 7 weeks (8 weeks max))
- Maximal oxygen consumption (VO₂max), measured by a smartwatch paired with an iPhone.(1 week and 7 weeks (8 weeks max))
- Number of daily steps, measured by a smartwatch paired with an iPhone.(1 week and 7 weeks (8 weeks max))
- Changes in the number of calories burned per day Calories burned per day, are measured by a smartwatch paired with an iPhone.(1 week and 7 weeks (8 maximum))
- Number of hospitalizations since the V1 visit(3 weeks and 7 weeks (8 maximum))
- Change of residence since the V1 visit (Yes or No)(3 weeks and 7 weeks (8 maximum))
- Changes in functional abilities measured by "Activities of Daily Living" (ADL) score (6 items)(baseline and 7 weeks (8 weeks maximum))
- Death (Yes or No)(3 weeks and 7 weeks (8 maximum))
- Program adherence is measured by the number of completed self-rehabilitation sessions for Intervention Group(7 weeks (8 weeks maximum))
- Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score(baseline and 7 weeks (8 weeks maximum))
- Number of falls showing signs of severity(baseline, 3 weeks and 7 weeks (8 maximum))
- Changes in functional abilities measured by Instrumental Activity of Daily Living (IADL) score (4 items)(baseline and 7 weeks (8 weeks maximum))