Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 11:41 PM
Study NCT ID:
NCT03493633
Status:
TERMINATED
Last Update Posted:
2023-03-21
First Post:
2018-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use EzyGain at Home (Device for Walking at Home)
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Study of Use of the EzyGain Training and Rehabilitation Device for Walking at Home
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
early termination - fault of inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EzyGain
Brief Summary:
Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the training work of walking in everyday life compared to a conventional care.
Detailed Description:
Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the work of training of walking in everyday life compared to a conventional care. In addition, we believe that this practice should be supervised by a caregiver trained by the physiotherapist / APA investigator, in order to increase the use of the device.
The people concerned by this protocol are those who have a partial disability of walking whatever the pathology and the underlying deficiencies.
Main objective: To evaluate the feasibility of using EzyGain at home.
Main Evaluation Criteria: Number of sessions performed on the device during the duration of the study, compared to the number of scheduled sessions.
Secondary objectives
Secondary objective 1: make a partial transfer of the supervision of the physiotherapist / APA investigator's sessions to the caregiver.
Secondary Objective 2: To evaluate whether the exercise period on the device increases the amount of spontaneous physical activity of the patient after the end of the period compared to the average spontaneous physical activity prior to the exercise period.
Population concerned:
Population over 60 years of age with partial walking disability regardless of etiology and pathology leading to walking disability.
Population coming into consultation in the services of Dr. Teixeira and Pr. Yelnik of GH Saint Louis Lariboisière Fernand Widal.
Partial incapacity of walking. Availability at home during their participation period (weeks of walking exercise + weeks of evaluation of physical activity).
Ethnicity indifferent Indifferent sex Patient with a close volunteer caregiver to participate in the study and receive training from the investigator / APA investigator and then manage sessions autonomously.
Anyone who would like to train more regularly on the walk and at home because unable to go out.
Who uses or does not use technical assistance to walk or move Patient who falls or is at risk of falling and, as a result, limits his progress.
Possibility of installation of the device in the patient's home. Patient affiliated to a social security scheme
Practical sequence:
Selection and medical inclusion of the patient by one of the investigating physicians and delivery of consent. During this visit, the doctor judges the eligibility criteria, explains the research to the patient, gives him the informed consent that is signed on the spot.
Among the eligibility criteria, there must be a caregiver close to the patient, who is willing to participate in the research. If he is present during this visit, he signs his consent to participate in the research. If he is absent during this visit, the patient gives his coordinates, the doctor calls him to explain the research, and sends his consent by mail, which the caregiver returns signed by mail to the doctor. It only remains to verify that the apartment can accommodate the device EzyGain.
Evaluation of the accessibility of the home by the EzyGain team. If the apartment can accommodate the device, then the patient is included in the search. If the apartment can not accommodate the device, then the patient is not included.
The first visit takes place on site with the investigator / APA investigator and an investigator. Laying the Actigraph ©.
Evaluation of the spontaneous physical activity of the patient by actimetry for seven days + QAPPA (questionnaire of physical activity for old person).
Beginning of the training phase on the device. The dosage of the activity (frequency of sessions and practical content) and the possibility of supervising additional sessions by a family caregiver is determined by the investigating physiotherapist / APA investigator.
Each patient performs a minimum of 3 sessions per week with the investigator / APA investigator, for 4 weeks, each walk for a few minutes (\<60 min).
Evaluation of the spontaneous physical activity of the patient by actimetry for seven days QAPPA (questionnaire of physical activity for elderly person) a week and a month after the training phase of four weeks
The people concerned by this protocol are those who have a partial disability of walking whatever the pathology and the underlying deficiencies.
Main objective: To evaluate the feasibility of using EzyGain at home.
Main Evaluation Criteria: Number of sessions performed on the device during the duration of the study, compared to the number of scheduled sessions.
Secondary objectives
Secondary objective 1: make a partial transfer of the supervision of the physiotherapist / APA investigator's sessions to the caregiver.
Secondary Objective 2: To evaluate whether the exercise period on the device increases the amount of spontaneous physical activity of the patient after the end of the period compared to the average spontaneous physical activity prior to the exercise period.
Population concerned:
Population over 60 years of age with partial walking disability regardless of etiology and pathology leading to walking disability.
Population coming into consultation in the services of Dr. Teixeira and Pr. Yelnik of GH Saint Louis Lariboisière Fernand Widal.
Partial incapacity of walking. Availability at home during their participation period (weeks of walking exercise + weeks of evaluation of physical activity).
Ethnicity indifferent Indifferent sex Patient with a close volunteer caregiver to participate in the study and receive training from the investigator / APA investigator and then manage sessions autonomously.
Anyone who would like to train more regularly on the walk and at home because unable to go out.
Who uses or does not use technical assistance to walk or move Patient who falls or is at risk of falling and, as a result, limits his progress.
Possibility of installation of the device in the patient's home. Patient affiliated to a social security scheme
Practical sequence:
Selection and medical inclusion of the patient by one of the investigating physicians and delivery of consent. During this visit, the doctor judges the eligibility criteria, explains the research to the patient, gives him the informed consent that is signed on the spot.
Among the eligibility criteria, there must be a caregiver close to the patient, who is willing to participate in the research. If he is present during this visit, he signs his consent to participate in the research. If he is absent during this visit, the patient gives his coordinates, the doctor calls him to explain the research, and sends his consent by mail, which the caregiver returns signed by mail to the doctor. It only remains to verify that the apartment can accommodate the device EzyGain.
Evaluation of the accessibility of the home by the EzyGain team. If the apartment can accommodate the device, then the patient is included in the search. If the apartment can not accommodate the device, then the patient is not included.
The first visit takes place on site with the investigator / APA investigator and an investigator. Laying the Actigraph ©.
Evaluation of the spontaneous physical activity of the patient by actimetry for seven days + QAPPA (questionnaire of physical activity for old person).
Beginning of the training phase on the device. The dosage of the activity (frequency of sessions and practical content) and the possibility of supervising additional sessions by a family caregiver is determined by the investigating physiotherapist / APA investigator.
Each patient performs a minimum of 3 sessions per week with the investigator / APA investigator, for 4 weeks, each walk for a few minutes (\<60 min).
Evaluation of the spontaneous physical activity of the patient by actimetry for seven days QAPPA (questionnaire of physical activity for elderly person) a week and a month after the training phase of four weeks
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A03170-53 | OTHER | IDRCB | View |