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CompletedNCT05239052Updated Mar 2, 2022

The Feasibility and Effect of PACUTS on Health Promotion for Stroke Wheelchair User in Long-term Care Institution

An interventional study of computer task intervention and conventional long-term care services in Stroke, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled May 2018, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Currently living in a long-term care institution
  • Stoke, onset over 6 months
  • Wheelchair user
  • Maintain sitting 30 minutes
  • No cognition impairment

Exclusion criteria

Exclusion Criteria:

  • Aphsia
  • Dementia, Cancer and MS
  • PNS impairment
  • Cardiopulmonary dysfunction
  • Visual impairment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    computer intervention group

    stroke subjects with wheelchair users completed computer screen tasks with affected arm or bilateral arm movement

    Other: computer task intervention

  • Active comparator
    conventional long-term care services group

    stroke subjects with wheelchair users receive conventional long-term care services

    Other: conventional long-term care services

Interventions

  • Othercomputer task intervention

    subject received programs for upper arm movement training with providing computer screen task activities

  • Otherconventional long-term care services

    stroke subjects with wheelchair users receive conventional long-term care services

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre-test, post-test(Change from pre-test Box and Block Test after 6 weeks' intervention)

  2. 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.

    Time frame: pre-test, post-test(Change from pre-test Grip Strength Assessment after 6 weeks' intervention)

  3. 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.

    Time frame: only post-test(after 6 weeks' intervention)

  4. 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.

    Time frame: pre-test, post-test(Change from pre-test Moss Attention Rating Scale after 6 weeks' intervention)

  5. upper limb endurance

    can raise your hands several times in a minute

    Time frame: pre-test, post-test(Change from pre-test upper limb endurance after 6 weeks' intervention)

Secondary outcomes

  1. 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.

    Time frame: pre-test and post-test(after 6 weeks' intervention)

  2. 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.

    Time frame: pre-test and post-test(after 6 weeks' intervention)

  3. 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.

    Time frame: pre-test and post-test(after 6 weeks' intervention)

07

Study locations

1 site
  • Department of Occupational Therapy
    Kaohsiung, 807, Taiwan
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — all collected IPD

Supporting information: Study protocol, Sap, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05239052
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Feb 14, 2022
Start date
May 18, 2018
Primary completion
Aug 6, 2019
Completion
Jun 8, 2020
Last update
Mar 2, 2022

Study contacts

Jyh-Jong Chang, PhD
principal investigator · Kaohsiung Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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