NCT05239052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2018

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
Last Updated

March 2, 2022

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

January 6, 2022

Last Update Submit

February 13, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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

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

Secondary Outcomes (3)

  • Barthel Index

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

  • The 12-Item Short Form Health Survey

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

  • Falls Efficacy Scale-International

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

Study Arms (2)

computer intervention group

EXPERIMENTAL

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

Other: computer task intervention

conventional long-term care services group

ACTIVE COMPARATOR

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

Other: conventional long-term care services

Interventions

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

computer intervention group

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

conventional long-term care services group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Occupational Therapy

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jyh-Jong Chang, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2022

First Posted

February 14, 2022

Study Start

May 18, 2018

Primary Completion

August 6, 2019

Study Completion

June 8, 2020

Last Updated

March 2, 2022

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
starting one year after publication
Access Criteria
For Meta-analysis study

Locations