Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical

Status Completed

Clinical Trial Summary

The investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. Our primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to prevent disability.

Clinical Trial Description

The object of the present project is to promote the prevention of disability by providing 1) a feed-back and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The device consists of a smart, removable insole. It measures dynamic characteristics of gait (e.g., speed, variability, distance) as well as body weight modifications with minimal invasiveness. The insole transmits wireless the collected data to a storage server through a touchpad. Data will then be available for at distance consultations by users (i.e., patients or physicians). The investigators will conduct a wide range of evaluations of the device (technical, clinical, social, ergonomic, and economic), which will allow the optimization of the prototype. The evaluation of the prototypes will preliminary takes place at the Blagnac smart house. 10 healthy volunteers will test the device. The second evaluation phase will involve 60 frail community-dwelling subjects, with 30 of them which will use the smart insoles for 3 months. Comprehensive assessments will be conducted to highlight the feasibility, acceptability, interoperability, integration in healthcare network, and clinical relevance of the technological device in comparison to usual care. ;

Study Design

Related Conditions & MeSH terms

Fragility

Clinical Trial Details

NCT number	NCT02316600
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Completed
Phase	N/A
Start date	January 2015
Completion date	July 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03009851` - Testing the Effectiveness of an Occupation-based Cultural Intervention in Long-term Care	N/A
Recruiting	`NCT04518423` - Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
Completed	`NCT02690402` - Fragility and Adapted Physical Activity	N/A
Completed	`NCT04110509` - Fragility and Programmed Cardiovascular Surgery (EcoSarco)
Completed	`NCT03320655` - Effectiveness of Combined Aerobic and Strength Training in Acute and Chronic Adaptations in Patients With Heart Failure	N/A
Active, not recruiting	`NCT01646632` - Exercise Intervention in Institutionalized Elderly People	Phase 2
Completed	`NCT04594655` - MPI Predicts Outcome of CRC Elderly Patients (MPI=MULTIDIMENSIONAL PROGNOSTIC INDEX; CRC=COLORECTAL CANCER)
Active, not recruiting	`NCT06361615` - Effect of a Dual-task Intervention Program on Physical and Cognitive Function	N/A
Completed	`NCT04151732` - Factors Associated With Future Fractures in Middle-aged Men and Women
Completed	`NCT04080063` - Biological Markers of Functional Effects of Physical Activity in an Elderly Population	N/A
Completed	`NCT06010069` - The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores
Recruiting	`NCT02952443` - Exercise Intervention to Reverse Frailty	N/A
Recruiting	`NCT04120012` - The Effect of Frailty to Perioperative Complications in the Elderly
Recruiting	`NCT02772952` - Effectiveness of a Multi-component Physical Training in Hyper-fragile Elders: A Randomized Clinical Trial	N/A
Recruiting	`NCT04092504` - Optimized Recovery After Trauma in Geriatric Patient	N/A
Completed	`NCT03958318` - Multi-component Exercise Program and Nutritional Supplementation in Frail Older Adults	N/A
Recruiting	`NCT05808686` - Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals	Phase 2
Completed	`NCT03246035` - Reducing Readmission for Frail Elderly Patients With Decompensated Heart Failure	N/A
Completed	`NCT03528005` - Effectiveness of Integrated Care Network	N/A
Withdrawn	`NCT02850731` - Motorized Platform and Autonomy Among the Frail and Pre-frail Older Adult (PLATAUTONOMIE)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life — RESPECT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms