An observational study in Physical Disability and Physical Activity, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Among 18 studies in Motor Activity by Assistance Publique - Hôpitaux de Paris — none open to participants now, 1 under way, none of them phase 3. Motor Activity · Assistance Publique - Hôpitaux de Paris.
Among the 18 studies in Motor Activity by Assistance Publique - Hôpitaux de Paris, this one is the only one that started in 2018, is one of 5 observational ones, and was the 10th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →None of the 18 studies in Motor Activity by Assistance Publique - Hôpitaux de Paris is open now.
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2018.
This study's enrollment of 15 is below the median of 98 across 1,235 observational studies indexed under Motor Activity.
Median enrollment 60 across the 13 interventional studies, 23 across the 5 observational. Of the 16 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 18 studies in Motor Activity by Assistance Publique - Hôpitaux de Paris, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Setting up a walking device at home for people aged 60 years with partial walking disability regardless of etiology and pathology leading to walking disability.
Device: EzyGain
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
Number of sessions performed on the device during the duration of the study
Count of the number of sessions performed. A session is considered to be performed when the patient is walking for at least one minute on the EzyGain treadmill with the APA investigator / caregiver.
Time frame: Up to 4 weeks
Number of sessions performed autonomously by the caregiver
Measure of the number of self-help sessions performed by the caregiver and their proportion to the total number of sessions completed.
Time frame: Up to 4 weeks
Physical activity evaluate by actimetry before the training period
Evaluate spontaneous physical activity by actimetry over a continuous period of 7 days before the beginning of the exercise period. At day #1 of the 7-day period : put the Actigraph© on the patient At day #7 of the 7-day period : take the Actigraph© off the patient
Time frame: At days 7 before the training period
Physical activity evaluate by QAPPA before the training period
Evaluate spontaneous physical activity by QAPPA, 7 days before the beginning of the exercise period. At day #7 of the 7-day period do the QAPPA
Time frame: At days 7 before the training period
Physical activity evaluate by actimetry just after the training period
Evaluate spontaneous physical activity by actimetry over a continuous period of 7 days starting the day after the end of the exercise period. At day #1 of the 7-day period : put the Actigraph© on the patient At day #7 of the 7-day period : take the Actigraph© off the patient
Time frame: At days 7 after the end of the training period
Physical activity evaluate by QAPPA just after the training period
Evaluate spontaneous physical activity by QAPPA over period of 7 days starting the day after the end of the exercise period. At day #7 of the 7-day period do the QAPPA
Time frame: At days 7 after the end of the training period
Physical activity evaluate by actimetry 3 weeks after the training period
Evaluate spontaneous physical activity by actimetry over a continuous period of 7 days starting 3 weeks after the end of the exercise period. At day #1 of the 7-day period : put the Actigraph© on the patient At day #7 of the 7-day period : take the Actigraph© off the patient
Time frame: At 3 weeks after the training period
Physical activity evaluate by QAPPA 3 weeks after the training period
Evaluate spontaneous physical activity by QAPPA over a continuous period of 7 days starting 3 weeks after the end of the exercise period. At day #7 of the 7-day period do QAPPA
Time frame: At 3 weeks after the training period
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Mar 2021, 31 months.
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This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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