Clinical trial NCT05239052: The Feasibility and Effect of PACUTS on Health Promotion for Stroke Wheelchair User in Long-term Care Institution
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* Aphsia
* Dementia, Cancer and MS
* PNS impairment
* Cardiopulmonary dysfunction
* Visual impairment

Primary outcomes:
measure: Box and Block Test
timeFrame: pre-test, post-test(Change from pre-test Box and Block Test after 6 weeks' intervention)
measure: Grip Strength Assessment
timeFrame: pre-test, post-test(Change from pre-test Grip Strength Assessment after 6 weeks' intervention)
measure: System Usability Scale
timeFrame: only post-test(after 6 weeks' intervention)
measure: Moss Attention Rating Scale
timeFrame: pre-test, post-test(Change from pre-test Moss Attention Rating Scale after 6 weeks' intervention)
measure: upper limb endurance
timeFrame: pre-test, post-test(Change from pre-test upper limb endurance after 6 weeks' intervention)
Secondary outcomes:
measure: Barthel Index
timeFrame: pre-test and post-test(after 6 weeks' intervention)
measure: The 12-Item Short Form Health Survey
timeFrame: pre-test and post-test(after 6 weeks' intervention)
measure: Falls Efficacy Scale-International
timeFrame: pre-test and post-test(after 6 weeks' intervention)
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Occupational Therapy
Study officials:
affiliation: Kaohsiung Medical University
name: Jyh-Jong Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.