Influence of Assistive Device Use While Performing Dual Task in Patients With Stroke

Stroke Clinical Trial

Official title:

Influence of Assistive Device Use on Dynamic Balance and the Associated Attentional Demands During Standing and Walking in Patients With Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00173719
• Other study ID #: 9100002423
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 26, 2013
• Start date: September 2003
• Est. completion date: July 2004

Study information

• Verified date: January 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2004
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

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

• 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

Exclusion Criteria:

• unable to follow the order of the experimenters, and having serious comprehension and expression impairment

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Standard cane

Locations

Country	Name	City	State
Taiwan	School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2003-2004	No
Secondary	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