NCT00173719

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2003

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

August 28, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

September 12, 2005

Last Update Submit

August 26, 2013

Conditions

Keywords

HemiplegiaAssisstive deviceWalkingDynamic equilibriumReaction timeAttentionDual task

Outcome Measures

Primary Outcomes (1)

  • 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

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

Interventions

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

StrokeHemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pei-Fang Tang, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

September 1, 2003

Primary Completion

January 1, 2004

Study Completion

July 1, 2004

Last Updated

August 28, 2013

Record last verified: 2013-01

Locations