StrokeNCT05239052
The Feasibility and Effect of PACUTS on Health Promotion for Stroke Wheelchair User in Long-term Care Institution
A study testing computer task intervention and conventional long-term care services in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Most of the residents in long-term care institution were wheelchair users, however, it would limit the participation in physical activities, and thus increase the degree of disability as they excessively rely on wheelchair. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- computer task intervention and conventional long-term care services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 May 2018to 8 Jun 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Currently living in a long-term care institution
- Stoke, onset over 6 months
- Wheelchair user
- Maintain sitting 30 minutes
- No cognition impairment
Who cannot join
- Aphsia
- Dementia, Cancer and MS
- PNS impairment
- Cardiopulmonary dysfunction
- Visual impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Effect of Physical Activity With Computerized Upper Limb Training Strategy on Health Promotion for Stroke Wheelchair User in Long-term Care Institution
Most of the residents in long-term care institution were wheelchair users, however, it would limit the participation in physical activities, and thus increase the degree of disability as they excessively rely on wheelchair. Recently, with the development of rehabilitation technology, the clients can receive more individualized physical activities intervention. Moreover, using technology as an assistive modality would reduce the demand of manpower, and provide higher treatment intensity with repeated training and objective performance feedback. Based upon our previous study finding from the physical activity with computerized upper limb training system (PACUTS), we propose to build a training strategy of physical activity for stroke wheelchair user in long-term care institution and to analyze its feasibility as well as the treatment effects, in the next two years.
The mixed method design will be applied. In the qualitative research, we will focus on the experience of physical activity training and subject's "adoption and acceptance" of the PACUTS. In terms of the quantitative research, 50 residents who currently live in long-term care institution will be recruited. Double-blinded randomized control-group pretest-posttest design will be conducted. In the experiment group, the participant will receive the intervention of PACUTS for 12 weeks/ 5 sessions per week/ 30 minutes, at least, per session. In terms of control group, the participant will receive a regular treatment program and physical activities scheduled by occupational therapist. This study is expected to contribute to build a training strategy with computerized upper limb training system which can helpfully promote the participation in physical activities and health outcomes for w/c residents living in long-term care institution.
Read the detailed description
In the past few years, the government has been focusing on community based care, the idea so-called aging-in-place. Therefore, the intervention model for residents in long-term care institution had been noticed by the researcher. Most of the residents in long-term care institution were wheelchair users, however, it would limit the participation in physical activities, and thus increase the degree of disability as they excessively rely on wheelchair. Recently, with the development of rehabilitation technology, the clients can receive more individualized physical activities intervention. Moreover, using technology as an assistive modality would reduce the demand of manpower, and provide higher treatment intensity with repeated training and objective performance feedback. Based upon our previous study finding from the physical activity with computerized upper limb training system (PACUTS), we propose to build a training strategy of physical activity for stroke wheelchair user in long-term care institution and to analyze its feasibility as well as the treatment effects, in the next two years.
The mixed method design will be applied. In the qualitative research, we will focus on the experience of physical activity training and subject's "adoption and acceptance" of the PACUTS. Through in-depth interview, field notes and different interviewers, the qualitative data analysis with phenomenology design will be applied. In terms of the quantitative research, 50 residents who currently live in long-term care institution will be recruited. Double-blinded randomized control-group pretest-posttest design will be conducted. In the experiment group, the participant will receive the intervention of PACUTS for 12 weeks/ 5 sessions per week/ 30 minutes, at least, per session. In terms of control group, the participant will receive a regular treatment program and physical activities scheduled by occupational therapist. Participants will be assessed by outcome measures, including Time Up and Go Test, Box and Block Test, Grip Strength Assessment, the Ruff 2 \& 7 Selective Attention Test, System Usability Scale, Barthel Index, SF-36 and the Falls Efficacy Scale-International. Descriptive statistics, independent-sample t test, paired-sample t test or mixed type 2-way ANOVA will be performed for data analysis. This study is expected to contribute to build a training strategy with computerized upper limb training system which can helpfully promote the participation in physical activities and health outcomes for w/c residents living in long-term care institution.
- Conditions
- Stroke
- Being tested
- computer task intervention, conventional long-term care services
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer task interventionOther
subject received programs for upper arm movement training with providing computer screen task activities
conventional long-term care servicesOther
stroke subjects with wheelchair users receive conventional long-term care services
| Study group | Role | What they receive |
|---|---|---|
| computer intervention group | Experimental | stroke subjects with wheelchair users completed computer screen tasks with affected arm or bilateral arm movement Receives: Other: computer task intervention |
| conventional long-term care services group | Active comparator | stroke subjects with wheelchair users receive conventional long-term care services Receives: Other: conventional long-term care services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.
Measured: pre-test, post-test(Change from pre-test Box and Block Test after 6 weeks' intervention)
Grip Strength Assessment
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.
Measured: pre-test, post-test(Change from pre-test Grip Strength Assessment after 6 weeks' intervention)
System Usability Scale
The System Usability Scale, or SUS, is a simple survey that provides a high-level score for the usability of a product.
Measured: only post-test(after 6 weeks' intervention)
Moss Attention Rating Scale
The MARS was designed as an observational rating scale to provide a reliable, quantitative and ecologically valid measure of attention-related behavior after TBI.
Measured: pre-test, post-test(Change from pre-test Moss Attention Rating Scale after 6 weeks' intervention)
upper limb endurance
can raise your hands several times in a minute
Measured: pre-test, post-test(Change from pre-test upper limb endurance after 6 weeks' intervention)
Secondary outcomes (3)
Barthel Index
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.
Measured: pre-test and post-test(after 6 weeks' intervention)
The 12-Item Short Form Health Survey
The 12-item Short Form Health Survey (SF-12) as a shorter alternative of the SF-36 is largely used in health outcomes surveys.
Measured: pre-test and post-test(after 6 weeks' intervention)
Falls Efficacy Scale-International
are measures of "fear of falling" or, more properly, "concerns about falling", which are suitable for use in research and clinical practice.
Measured: pre-test and post-test(after 6 weeks' intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start18 May 2018
- Primary completion6 Aug 2019
- Study completion8 Jun 2020
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 StrokeStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyh-Jong Chang, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239052
- Sponsor's protocol ID
- KMUHIRB-F(I)-20180035
- Status last verified
- May 2018
- First submitted
- 6 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Chen KM, Li CH, Huang HT, Cheng YY. Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trial. Int J Nurs Stud. 2016 Mar;55:4-14. doi: 10.1016/j.ijnurstu.2015.11.004. Epub 2015 Nov 28.
PubMed 26655368
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effect of Physical Activity With Computerized Upper Limb Training Strategy on Health Promotion for Stroke Wheelchair User in Long-term Care Institution
- ClinicalTrials.gov ID
- NCT05239052
- Acronym / sponsor ID
- KMUHIRB-F(I)-20180035
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 14 Feb 2022 (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.
Most of the residents in long-term care institution were wheelchair users, however, it would limit the participation in physical activities, and thus increase the degree of disability as they excessively rely on wheelchair. Recently, with the development of rehabilitation technology, the clients can receive more individualized physical activities intervention. Moreover, using technology as an assistive modality would reduce the demand of manpower, and provide higher treatment intensity with repeated training and objective performance feedback. Based upon our previous study finding from the physical activity with computerized upper limb training system (PACUTS), we propose to build a training strategy of physical activity for stroke wheelchair user in long-term care institution and to analyze its feasibility as well as the treatment effects, in the next two years.
The mixed method design will be applied. In the qualitative research, we will focus on the experience of physical activity training and subject's "adoption and acceptance" of the PACUTS. In terms of the quantitative research, 50 residents who currently live in long-term care institution will be recruited. Double-blinded randomized control-group pretest-posttest design will be conducted. In the experiment group, the participant will receive the intervention of PACUTS for 12 weeks/ 5 sessions per week/ 30 minutes, at least, per session. In terms of control group, the participant will receive a regular treatment program and physical activities scheduled by occupational therapist. This study is expected to contribute to build a training strategy with computerized upper limb training system which can helpfully promote the participation in physical activities and health outcomes for w/c residents living in long-term care institution.
Detailed description
In the past few years, the government has been focusing on community based care, the idea so-called aging-in-place. Therefore, the intervention model for residents in long-term care institution had been noticed by the researcher. Most of the residents in long-term care institution were wheelchair users, however, it would limit the participation in physical activities, and thus increase the degree of disability as they excessively rely on wheelchair. Recently, with the development of rehabilitation technology, the clients can receive more individualized physical activities intervention. Moreover, using technology as an assistive modality would reduce the demand of manpower, and provide higher treatment intensity with repeated training and objective performance feedback. Based upon our previous study finding from the physical activity with computerized upper limb training system (PACUTS), we propose to build a training strategy of physical activity for stroke wheelchair user in long-term care institution and to analyze its feasibility as well as the treatment effects, in the next two years.
The mixed method design will be applied. In the qualitative research, we will focus on the experience of physical activity training and subject's "adoption and acceptance" of the PACUTS. Through in-depth interview, field notes and different interviewers, the qualitative data analysis with phenomenology design will be applied. In terms of the quantitative research, 50 residents who currently live in long-term care institution will be recruited. Double-blinded randomized control-group pretest-posttest design will be conducted. In the experiment group, the participant will receive the intervention of PACUTS for 12 weeks/ 5 sessions per week/ 30 minutes, at least, per session. In terms of control group, the participant will receive a regular treatment program and physical activities scheduled by occupational therapist. Participants will be assessed by outcome measures, including Time Up and Go Test, Box and Block Test, Grip Strength Assessment, the Ruff 2 \& 7 Selective Attention Test, System Usability Scale, Barthel Index, SF-36 and the Falls Efficacy Scale-International. Descriptive statistics, independent-sample t test, paired-sample t test or mixed type 2-way ANOVA will be performed for data analysis. This study is expected to contribute to build a training strategy with computerized upper limb training system which can helpfully promote the participation in physical activities and health outcomes for w/c residents living in long-term care institution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computer intervention group | Experimental | Other: computer task interventionstroke subjects with wheelchair users completed computer screen tasks with affected arm or bilateral arm movement |
| conventional long-term care services group | Active comparator | Other: conventional long-term care servicesstroke subjects with wheelchair users receive conventional long-term care services |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Currently living in a long-term care institution
- Stoke, onset over 6 months
- Wheelchair user
- Maintain sitting 30 minutes
- No cognition impairment
Key exclusion criteria (5 listed)
- Aphsia
- Dementia, Cancer and MS
- PNS impairment
- Cardiopulmonary dysfunction
- Visual impairment
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 |
|---|---|---|
| computer task interventionsubject received programs for upper arm movement training with providing computer screen task activities | Other | computer intervention group |
| conventional long-term care servicesstroke subjects with wheelchair users receive conventional long-term care services | Other | conventional long-term care services group |
Primary outcome
Box and Block Test
Time frame: pre-test, post-test(Change from pre-test Box and Block Test after 6 weeks' intervention)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke.
Grip Strength Assessment
Time frame: pre-test, post-test(Change from pre-test Grip Strength Assessment after 6 weeks' intervention)
Grip strength is a measure of muscular strength or the maximum force/tension generated by one's forearm muscles. It can be used as a screening tool for the measurement of upper body strength and overall strength.
System Usability Scale
Time frame: only post-test(after 6 weeks' intervention)
The System Usability Scale, or SUS, is a simple survey that provides a high-level score for the usability of a product.
Moss Attention Rating Scale
Time frame: pre-test, post-test(Change from pre-test Moss Attention Rating Scale after 6 weeks' intervention)
The MARS was designed as an observational rating scale to provide a reliable, quantitative and ecologically valid measure of attention-related behavior after TBI.
upper limb endurance
Time frame: pre-test, post-test(Change from pre-test upper limb endurance after 6 weeks' intervention)
can raise your hands several times in a minute
3 secondary outcomes
Barthel Index
Time frame: pre-test and post-test(after 6 weeks' intervention)
The 12-Item Short Form Health Survey
Time frame: pre-test and post-test(after 6 weeks' intervention)
Falls Efficacy Scale-International
Time frame: pre-test and post-test(after 6 weeks' intervention)
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 2 Mar 2022.
- Results publication: PubMed 26655368Chen KM, Li CH, Huang HT, Cheng YY. Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trial. Int J Nurs Stud. 2016 Mar;55:4-14. doi: 10.1016/j.ijnurstu.2015.11.004. Epub 2015 Nov 28.
- Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected IPD
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Jyh-Jong Chang, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computer task intervention and conventional long-term care services in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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 2 Mar 2022. 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 Taiwan. 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?
Box and Block Test (time frame: pre-test, post-test(Change from pre-test Box and Block Test after 6 weeks' intervention)). The study lists 5 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 NCT05239052, 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 2 Mar 2022.