|- candidate number||16399|
|- NTR Number||NTR4378|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-feb-2014|
|- Secondary IDs||13N175 METC Atrium-Orbis-Zuyd|
|- Public Title||Onderzoek naar de ervaren meerwaarde van armondersteuningen in het dagelijks leven|
|- Scientific Title||Assessment of the perceived functional benefits of dynamic arm supports|
|- hypothesis||The aim of this study is to assess the functional benefit of dynamic arm supports (type of assistive technology) in the domestic setting and the contributing factors. This could support the prescription process of these devices and could support future developments. |
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||•Subjects are provided with a dynamic arm support in 2012 or January till June 2013.
•Age 12 years or older
•Subjects are provided with a dynamic arm support for ADL purposes (not to provide support at work solely)
|- Exclusion criteria||•not speaking Dutch|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||21-feb-2014|
|- planned closingdate||31-jul-2014|
|- Target number of participants||50|
|- Primary outcome||The perceived functional benefit of dynamic arm supports|
|- Secondary outcome||•Performance and quality of performance of daily activities with and without dynamic arm support
•Frequency of use
•Upper extremity function
•Activities performed with other assistive devices in daily life
•Activities performed with the help of others in daily life
•Activities performed with the help of adaptations in daily life
•Functional limitations of the dynamic arm support
•Satisfaction with device
•Habituation to the device and general life world experience by the elderly population
|- Timepoints||One time point consisting of a questionnaire and an observation and in some cases (65+) an in-depth interview|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L van der Heide|
|- CONTACT for SCIENTIFIC QUERIES|| L van der Heide|
|- Sponsor/Initiator ||Zuyd University of Applied Sciences, Research Centre for Autonomy and Participation of people with a chronic illness|
(Source(s) of Monetary or Material Support)
|- Brief summary||Introduction: In the past seventy years over 100 devices were designed to support people who suffer from a decreased arm function in the performance of common activities of daily living. These devices are called dynamic arm supports. Evaluations have been performed on a limited number of the devices developed and these studies are in most cases limited to controlled (laboratory) studies. Outcomes of these studies are in general positive regarding the ability to perform daily activities. The minority of the devices developed have also been evaluated in real life. In cases longer term use of devices was assessed, often a relatively high level of non-use was found. This suggests that next to the ability of devices to support in daily activities, there are other factors that might explain whether a user experiences a device as functionally beneficial for them. Other factors that might influence functional benefit are among others expected to be practical issues, functional goals, upper extremity function, and the experienced life world. Insight into the functional benefit of dynamic arm supports and contributing factors could support the prescription process of these devices, but this knowledge is currently lacking.
Aim: The aim of this study is to assess the functional benefit of dynamic arm supports in the domestic setting and the contributing factors.
Design: The research question is assessed in an observational study, a mixed methods approach, consisting of a questionnaire, and interview/observation and an in-depth interview.
Study population: Subjects recruited are dynamic arm support users that were provided with their device between January 2012 till June 2013. Additional inclusion criteria are: subjects are 12 years or older and the devices were prescribed for daily activities purposes. If subjects are not speaking Dutch they are excluded.
Study procedure: 225 subjects are invited to participate by four Dutch suppliers of dynamic arm supports. All subjects fill out the questionnaire, a maximum of 50 subjects participate in the interview/observation and 10 elderly participate in the in-depth interview. The questionnaire consists of the Life-Habits questionnaire to assess how daily activities are usually performed, how difficult this is and whether assistive devices, adaptation or human assistance is required. Additionally, some questions on participant characteristics are assessed. The interview elaborates on the answers given in the questionnaire, and the performance of a set of daily tasks is observed. Additionally arm function, perceived functional benefit, and use satisfaction are assessed. The in-depth interview focuses on the general life world experience of elderly subjects using a dynamic arm support.
Data analysis: The functional benefit is calculated for each user and correlations between the perceived functional benefit and the factors that could explain this benefit (such as arm function, device satisfaction) are computed.
|- Main changes (audit trail)|
|- RECORD||11-feb-2014 - 27-mrt-2014|