StrokeNCT00173719
Influence of Assistive Device Use While Performing Dual Task in Patients With Stroke
A study testing Standard cane in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The primary purposes of the this three-year research proposal are to investigate the influence of assistive device use on dynamic balance and the associated attentional demands during standing and walking in patients with stroke Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Standard cane
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2003to Jul 2004
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- between 50 and 75 years old
- having no neuromuscular or musculoskeletal disorders that would jeopardize their balance control abilities
- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
- Stroke patients
- between 50 and 75 years old
Show all 11Show fewer
- hemiplegic or hemiparetic as a result of a single cerebral vascular accident
- medically stable with no ongoing complications
- independently walking without using any assistive device for at least 10 meters, and have the exercise endurance for at least 30 minutes
- having no serious hemianopsia, hemi-inattention or any obvious cognitive problems as evaluated with the Mini-Mental State examination
- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
Who cannot join
- unable to follow the order of the experimenters, and having serious comprehension and expression impairment
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
Taipei, 100
About this study
Official title: Influence of Assistive Device Use on Dynamic Balance and the Associated Attentional Demands During Standing and Walking in Patients With Stroke
The primary purposes of the this three-year research proposal are to investigate the influence of assistive device use on dynamic balance and the associated attentional demands during standing and walking in patients with stroke
Read the detailed description
Research has shown the effectiveness of using ambulatory assistive devices to increase standing stability of patients with stroke in clinical practice (Maeda et al., 2001). However, literature has also suggested that manipulation of ambulatory assistive devices in dynamic motor tasks, such as walking, inevitably requires additional attention, even in healthy adults (Wright \& Kemp, 1992). Given that the majority of patients with stroke suffer from balance control difficulty, which subsequently increases their attentional demands associated with maintaining balance (Brown et al., 2002), it remains an important question as to whether the use of ambulatory assistive devices would take away some attentional resources that would otherwise be used for maintaining balance.
- Conditions
- Stroke
- Being tested
- Standard cane
- Keywords
- Hemiplegia, Assisstive device, Walking, Dynamic equilibrium, Reaction time, Attention, Dual task
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard caneDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the voice reaction time and response accuracy while simultaneously performing the dual task with or without using assistive devices for healthy adults and stroke patients
Measured: 2003-2004
Secondary outcomes (1)
To investigate the related gait parameters(ex. walking speed, stride length, gait cycle time, and foot pressure etc.)while simultaneously performing the dual task with or without using assistive devices for healthy adults and stroke patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJan 2004
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Pei-Fang Tang, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00173719
- Sponsor's protocol ID
- 9100002423
- Status last verified
- Jan 2013
- First submitted
- 12 Sep 2005
- Last updated
- 28 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Assistive Device Use on Dynamic Balance and the Associated Attentional Demands During Standing and Walking in Patients With Stroke
- ClinicalTrials.gov ID
- NCT00173719
- Acronym / sponsor ID
- 9100002423
- Conditions
- Stroke
- Keywords
- Hemiplegia, Assisstive device, Walking, Dynamic equilibrium, Reaction time, Attention, Dual task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Sep 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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.
The primary purposes of the this three-year research proposal are to investigate the influence of assistive device use on dynamic balance and the associated attentional demands during standing and walking in patients with stroke
Detailed description
Research has shown the effectiveness of using ambulatory assistive devices to increase standing stability of patients with stroke in clinical practice (Maeda et al., 2001). However, literature has also suggested that manipulation of ambulatory assistive devices in dynamic motor tasks, such as walking, inevitably requires additional attention, even in healthy adults (Wright \& Kemp, 1992). Given that the majority of patients with stroke suffer from balance control difficulty, which subsequently increases their attentional demands associated with maintaining balance (Brown et al., 2002), it remains an important question as to whether the use of ambulatory assistive devices would take away some attentional resources that would otherwise be used for maintaining balance.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy adults
- between 50 and 75 years old
- having no neuromuscular or musculoskeletal disorders that would jeopardize their balance control abilities
- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
- Stroke patients
Key exclusion criteria (1 listed)
- unable to follow the order of the experimenters, and having serious comprehension and expression 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 |
|---|---|---|
| Standard cane | Device | – |
Primary outcome
To investigate the voice reaction time and response accuracy while simultaneously performing the dual task with or without using assistive devices for healthy adults and stroke patients
Time frame: 2003-2004
1 secondary outcome
To investigate the related gait parameters(ex. walking speed, stride length, gait cycle time, and foot pressure etc.)while simultaneously performing the dual task with or without using assistive devices for healthy adults and stroke patients
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 28 Aug 2013.
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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.
Pei-Fang Tang, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard cane in people with Stroke, run by National Taiwan University 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 11 inclusion and 1 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 28 Aug 2013. 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?
To investigate the voice reaction time and response accuracy while simultaneously performing the dual task with or without using assistive devices for healthy adults and stroke patients (time frame: 2003-2004). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2013.