Use EzyGain at Home (Device for Walking at Home)

NCT03493633 | Terminated

• 2 other identifiers: P170705J2017-A03170-53
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Disability; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 4 weeks

Secondary Outcomes (7)

• Number of sessions performed autonomously by the caregiver

  Up to 4 weeks

• Physical activity evaluate by actimetry before the training period

  At days 7 before the training period

• Physical activity evaluate by QAPPA before the training period

  At days 7 before the training period

• Physical activity evaluate by actimetry just after the training period

  At days 7 after the end of the training period

• Physical activity evaluate by QAPPA just after the training period

  At days 7 after the end of the training period

Study Arms (1)

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.

Device: EzyGain

Interventions

EzyGain DEVICE

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

EzyGain at Home

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Physique et de Réadaptation - Hôpital F.Widal

Paris, 75010, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Alain YELNIK

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: April 10, 2018
• Study Start: July 31, 2018
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

FR (1)