Feasibility of a Technology-based System in Aged Personi-ACT-agedNCT04489563
Feasibility Study of i-ACT in Aged Persons
A study testing i-ACT in people with Feasibility of a Technology-based System in Aged Person, run by PXL University College at 5 sites in Belgium.
Trial summary
A mix-method cross-sectional feasibility study performed in five aged care institutes in Flanders, Belgium. A convenience sample of 48 aged persons was recruited and 12 supervisors (i.e. occupational therapy students and therapists). Aged persons received a 20-30 minutes test with a technology-based system, i.e. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Feasibility of a Technology-based System in Aged Person
- What is being tested?
- i-ACT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesBelgium
- Study dates
- 1 Mar 2017to 12 May 2019
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- a client of the participating centres
- cognitively able to understand and respond to questions
- follow up instructions
- understand and speak the Dutch language
Who cannot join
- severe spasticity that unables participants to perform exercises
- severe visual impairment (e.g. blindness, cataract, etc.)
- severe communication disorder that unables participants to understand and follow up instructions (e.g. aphasia, agnosia, etc.)
- persons who use electric wheelchairs who are not able to make a transfer towards a chair.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Plankeweeke
Hasselt, Limburg, 3500
Begralim
Riemst, Limburg, 3770
Begralim
Tongeren, Limburg, 3717
DVC H. Catharina
Zonhoven, Limburg, 3520
WZC H. Catharina
Zonhoven, Limburg, 3520
About this study
Official title: Intelligent Activity-based Client-centred Training (i-ACT) in Aged Persons
A mix-method cross-sectional feasibility study performed in five aged care institutes in Flanders, Belgium. A convenience sample of 48 aged persons was recruited and 12 supervisors (i.e. occupational therapy students and therapists).
Aged persons received a 20-30 minutes test with a technology-based system, i.e. intelligent Activity-based Client-centred Training system (i-ACT). The i-ACT consists of the Microsoft Kinect and adapted software in which movements can be recorded and training parameters can be set by supervisors.
During and after the test, the thinking aloud method was used. After the test, the Intrinsic Motivation Inventory, the System Usability Scale, and the Credibility/Expectancy Questionnaire were administered in the aged persons.
- Being tested
- i-ACT
- Keywords
- physical activity, aged persons, technology, client-centred
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-ACTDevice
Also called Kinect
Performing exercises with an adapted motion detection device (i.ACT) for 20-30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aged persons | Other | A feasibility test of 20-30 minutes in aged persons with an adapted Kinect-based system, i.e. i-ACT. Receives: Device: i-ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrinsic motivation
Using the Intrinsic Motivation Inventory to record motivational aspects
Measured: 30 minutes
Usability of i-ACT
Using the System Usability Scale to explore the usability of i-ACT in aged persons. The System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of 72.5 or higher is considered good and above 85.0 is excellent.
Measured: 10 minutes
Credibility/expectancy
Using the Credibility/Expectancy Questionnaire to research the credibility and expectancy of aged persons when using the i-ACT for physical activity. It is one test that consists of 2 subscales, i.e. credibility and expectancy, and scores range from 1 (totally not) to 9 (totally yes) and percentages. The percentages are converted to scores on a scale of 1 to 9/ The maximum score on each subscale is 27. A score of 13.5 is considered neutral, everything above 13.5 is positive while everything under 13.5 is considered negative.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Mar 2017
- Primary completion12 May 2019
- Study completion12 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feasibility of a Technology-based System in Aged PersonStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A group of aged persons and their supervisors in day care facilities or nursing homes participated in this study to investigate the feasibility of the i-ACT system for use to engage and motivate aged persons in institutional facilities to perform physical activity. The aged persons received a 20-30 minutes test period with the self-developed programme of the i-ACT (based on hard- and software of the Microsoft Kinect). During and after the test, the feedback of the participants was noted by the supervisor (using the thinking aloud method). After the test, 3 questionnaires were conducted, i.e. the Intrinsic Motivation Inventory (IMI), System Usability Scale (SUS), and Credibility/Expectancy Questionnaire (CEQ). The feedback from the supervisors was also noted as part of the thinking aloud method to gather as much information as needed to adapt the prototype of the i-ACT system towards the wishes and needs from aged persons.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- PXL University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489563
- Sponsor's protocol ID
- i-ACT elderly
- Acronym
- i-ACT-aged
- Status last verified
- Jul 2020
- First submitted
- 23 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Knippenberg E, Timmermans A, Palmaers S, Spooren A. Use of a technology-based system to motivate older adults in performing physical activity: a feasibility study. BMC Geriatr. 2021 Jan 28;21(1):81. doi: 10.1186/s12877-021-02021-3.
PubMed 33509098
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Activity-based Client-centred Training (i-ACT) in Aged Persons
- ClinicalTrials.gov ID
- NCT04489563
- Acronym / sponsor ID
- i-ACT-aged / i-ACT elderly
- Keywords
- physical activity, aged persons, technology, client-centred
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- PXL University CollegeUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 12 May 2019 (actual)
- First posted
- 28 Jul 2020 (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.
A mix-method cross-sectional feasibility study performed in five aged care institutes in Flanders, Belgium. A convenience sample of 48 aged persons was recruited and 12 supervisors (i.e. occupational therapy students and therapists).
Aged persons received a 20-30 minutes test with a technology-based system, i.e. intelligent Activity-based Client-centred Training system (i-ACT). The i-ACT consists of the Microsoft Kinect and adapted software in which movements can be recorded and training parameters can be set by supervisors.
During and after the test, the thinking aloud method was used. After the test, the Intrinsic Motivation Inventory, the System Usability Scale, and the Credibility/Expectancy Questionnaire were administered in the aged persons.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A group of aged persons and their supervisors in day care facilities or nursing homes participated in this study to investigate the feasibility of the i-ACT system for use to engage and motivate aged persons in institutional facilities to perform physical activity. The aged persons received a 20-30 minutes test period with the self-developed programme of the i-ACT (based on hard- and software of the Microsoft Kinect). During and after the test, the feedback of the participants was noted by the supervisor (using the thinking aloud method). After the test, 3 questionnaires were conducted, i.e. the Intrinsic Motivation Inventory (IMI), System Usability Scale (SUS), and Credibility/Expectancy Questionnaire (CEQ). The feedback from the supervisors was also noted as part of the thinking aloud method to gather as much information as needed to adapt the prototype of the i-ACT system towards the wishes and needs from aged persons.
| Arm | Type | Receives |
|---|---|---|
| Aged persons | Other | Device: i-ACTA feasibility test of 20-30 minutes in aged persons with an adapted Kinect-based system, i.e. i-ACT. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- a client of the participating centres
- cognitively able to understand and respond to questions
- follow up instructions
- understand and speak the Dutch language
Key exclusion criteria (4 listed)
- severe spasticity that unables participants to perform exercises
- severe visual impairment (e.g. blindness, cataract, etc.)
- severe communication disorder that unables participants to understand and follow up instructions (e.g. aphasia, agnosia, etc.)
- persons who use electric wheelchairs who are not able to make a transfer towards a chair.
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 |
|---|---|---|
| i-ACTAlso: KinectPerforming exercises with an adapted motion detection device (i.ACT) for 20-30 minutes. | Device | Aged persons |
Primary outcome
Intrinsic motivation
Time frame: 30 minutes
Using the Intrinsic Motivation Inventory to record motivational aspects
Usability of i-ACT
Time frame: 10 minutes
Using the System Usability Scale to explore the usability of i-ACT in aged persons. The System Usability Scale consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. The items scores are converted into a score from 0 (negative) to 100 (positive). A score of 72.5 or higher is considered good and above 85.0 is excellent.
Credibility/expectancy
Time frame: 10 minutes
Using the Credibility/Expectancy Questionnaire to research the credibility and expectancy of aged persons when using the i-ACT for physical activity. It is one test that consists of 2 subscales, i.e. credibility and expectancy, and scores range from 1 (totally not) to 9 (totally yes) and percentages. The percentages are converted to scores on a scale of 1 to 9/ The maximum score on each subscale is 27. A score of 13.5 is considered neutral, everything above 13.5 is positive while everything under 13.5 is considered negative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 33509098Knippenberg E, Timmermans A, Palmaers S, Spooren A. Use of a technology-based system to motivate older adults in performing physical activity: a feasibility study. BMC Geriatr. 2021 Jan 28;21(1):81. doi: 10.1186/s12877-021-02021-3.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-ACT in people with Feasibility of a Technology-based System in Aged Person, run by PXL University College at 5 sites in Belgium.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intrinsic motivation (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489563, which also lists 1 linked publication.
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 28 Jul 2020.