Physical DisabilityEzyGainNCT03493633
Use EzyGain at Home (Device for Walking at Home)
An observational study of Physical Disability and Physical Activity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Physical Disability, Physical Activity
- What is being tested?
- EzyGain
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jul 2018to 15 Mar 2021
- How long will I take part?
- 9 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Person over the age of 60
- Availability at home during their participation period (walking exercise weeks + physical activity assessment weeks).
- Patient with a volunteer close caregiver to participate in the study and receive training from the investigator/APA investigator and then manage autonomy sessions.
- Person who would like to train more regularly in the walk and at home because unable to get out. Person who uses or does not use technical assistance to walk or move
- Person in a State to sign informed consent alone
- Possibility of installation of the device in the patient's home (the dimensions of the lift/doors/parts allow the device to be entered in the apartment, as well as not to hinder the daily life of the patient too heavily).
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- Patient affiliated with a Social security plan
- Person who has a partial limitation of walking activity (partial inability to walk) and in whom, re-education of walking is relevant to improve performance (whether or not the patient does this re-education at the time of the visit of selection). The criteria for limiting walking activity are:
- Speed limitation
- Endurance limitation
- Limitation of the operating perimeter
- Limitation of the dynamic balancing during walking failure to position the foot or feet during walking
- Falls
- Availability at home during their time of participation.
- Indifferent ethnic origin
- Indifferent sex
Who cannot join
- Uncontrolled heart failure
- Uncontrolled respiratory insufficiency
- Uncontrolled coronary insufficiency
- Impossibility of installing the device at home
- Severe cognitive impairment with risk of using the device alone, outside of the instructions
- Absence of a caregiver to follow a continuous training of the physiotherapist / - APA investigator to supervise independently one or two sessions per week
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et de Réadaptation - Hôpital F.Widal
Paris, 75010
About this study
Official title: Study of Use of the EzyGain Training and Rehabilitation Device for Walking at Home
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.
Read the 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
- Conditions
- Physical Disability, Physical Activity
- Being tested
- EzyGain
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzyGainDevice
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 group | Role | What they receive |
|---|---|---|
| EzyGain at Home | 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. Receives: Device: EzyGain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 3 weeks after the training period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start31 Jul 2018
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Why it stopped: early termination - fault of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 9 Weeks
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain YELNIK, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493633
- Sponsor's protocol ID
- P170705J
- Other IDs
- 2017-A03170-53
- Acronym
- EzyGain
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2018
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Use of the EzyGain Training and Rehabilitation Device for Walking at Home
- ClinicalTrials.gov ID
- NCT03493633
- Acronym / sponsor ID
- EzyGain / P170705J
- Conditions
- Physical Disability, Physical Activity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: early termination - fault of inclusion
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 9 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EzyGain at Home | – | Device: EzyGainSetting up a walking device at home for people aged 60 years with partial walking disability regardless of etiology and pathology leading to walking disability. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (16 listed)
- Person over the age of 60
- Availability at home during their participation period (walking exercise weeks + physical activity assessment weeks).
- Patient with a volunteer close caregiver to participate in the study and receive training from the investigator/APA investigator and then manage autonomy sessions.
- Person who would like to train more regularly in the walk and at home because unable to get out. Person who uses or does not use technical assistance to walk or move
- Person in a State to sign informed consent alone
Key exclusion criteria (6 listed)
- Uncontrolled heart failure
- Uncontrolled respiratory insufficiency
- Uncontrolled coronary insufficiency
- Impossibility of installing the device at home
- Severe cognitive impairment with risk of using the device alone, outside of the instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EzyGainEach 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 | Device | EzyGain at Home |
Primary outcome
Number of sessions performed on the device during the duration of the study
Time frame: Up to 4 weeks
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.
7 secondary outcomes
Number of sessions performed autonomously by the caregiver
Time frame: Up to 4 weeks
Physical activity evaluate by actimetry before the training period
Time frame: At days 7 before the training period
Physical activity evaluate by QAPPA before the training period
Time frame: At days 7 before the training period
Physical activity evaluate by actimetry just after the training period
Time frame: At days 7 after the end of the training period
Physical activity evaluate by QAPPA just after the training period
Time frame: At days 7 after the end of the training period
Physical activity evaluate by actimetry 3 weeks after the training period
Time frame: At 3 weeks after the training period
Physical activity evaluate by QAPPA 3 weeks after the training period
Time frame: At 3 weeks after the training period
Results and safety
The study was stopped early (reason given: early termination - fault of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain YELNIK principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Disability and Physical Activity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: early termination - fault of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sessions performed on the device during the duration of the study (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.