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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
computer task intervention
conventional long-term care services
Sponsored by
Kaohsiung Medical University Chung-Ho Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Occupational Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

computer intervention group

conventional long-term care services group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
upper limb endurance
can raise your hands several times in a minute

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 6, 2022
Last Updated
February 13, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05239052
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 18, 2018 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
June 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
computer intervention group
Arm Type
Experimental
Arm Description
stroke subjects with wheelchair users completed computer screen tasks with affected arm or bilateral arm movement
Arm Title
conventional long-term care services group
Arm Type
Active Comparator
Arm Description
stroke subjects with wheelchair users receive conventional long-term care services
Intervention Type
Other
Intervention Name(s)
computer task intervention
Intervention Description
subject received programs for upper arm movement training with providing computer screen task activities
Intervention Type
Other
Intervention Name(s)
conventional long-term care services
Intervention Description
stroke subjects with wheelchair users receive conventional long-term care services
Primary Outcome Measure Information:
Title
Box and Block Test
Description
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)
Title
Grip Strength Assessment
Description
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)
Title
System Usability Scale
Description
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)
Title
Moss Attention Rating Scale
Description
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)
Title
upper limb endurance
Description
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 Outcome Measure Information:
Title
Barthel Index
Description
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)
Title
The 12-Item Short Form Health Survey
Description
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)
Title
Falls Efficacy Scale-International
Description
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)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-Jong Chang, PhD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Occupational Therapy
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD
IPD Sharing Time Frame
starting one year after publication
IPD Sharing Access Criteria
For Meta-analysis study
Citations:
PubMed Identifier
26655368
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/26655368/
Description
Feasible modalities and long-term effects of elastic band exercises in nursing home older adults in wheelchairs: A cluster randomized controlled trial

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

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