NCT00173992

Brief Summary

The specific aims of this research are delineated as the following: Aim 1: To investigate the neuromuscular and biomechanical mechanisms of the emerging processes of proactive and reactive balance control during sitting and standing in patients with stroke at different stages of the recovery course. Aim 2: To determine the relationships between brain lesion sites and the recovery patterns of reactive and proactive balance control mechanisms in patients with stroke. Aim 3: To determine the relationships between the impairments in reactive and proactive balance control mechanisms and functional outcome as well as fall incidence in patients following stroke. Aim 4: To investigate the efficacy of different training regimens in improving reactive and proactive balance control strategies and in preventing falls in stroke patients with different brain lesion sites. Principally, three hypotheses are to be tested: Hypothesis 1:The emerging processes and recovery patternes of proactive and reactive balance control may be different among stroke patients with different brain lesion locations. Hypothesis 2:There are positive correlations between the level of impairments in reactive and proactive balance control mechanisms and functional outcome as well as fall incidence in patients following stroke. Hypothesis 3:Training regimens that could best facilitate the emergence or improvement in reactive and proactive balance control strategies are different.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 30, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

September 15, 2005

Status Verified

June 1, 2005

First QC Date

June 30, 2005

Last Update Submit

September 13, 2005

Conditions

Stroke

Keywords

StrokeBalanceProactive controlReactive controlRecoveryTrainingFall

Outcome Measures

Primary Outcomes (1)

  • To investigate the balance recovery(proactive postural adujustments and reactive postural reaction) post-onset of each stroke subject

Secondary Outcomes (1)

  • To investigate the incidence of falls before and after training

Interventions

Balance and ExerciseBEHAVIORAL

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects
  • Age ang Sex are correspond with the stroke subjects(between 45 and 75 years old)
  • having the habit of regular exercise (at least twice a week, and at least 20 minutes duration each time)
  • being willing to accept one-year follow-up examination
  • being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
  • Stroke subjects
  • between 45 and 75 years old
  • cerebral infarction stroke confirmed by ICD-10-CM and brain imaging diagnosis(including I63.0, I63.1, I63.2, I63.3, I63.4, I63.5, I63.6, I63.8, and I63.9)
  • first stroke and received acute treatment at NTUH
  • being willing to accept one-year follow-up 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:

  • Healthy subjects
  • having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those would influence the belance or motor ability Stroke subjects
  • on the 14st day after stroke onset, having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
  • having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases other than stroke

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

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pei-Fang Tang, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Fang Tang, PhD

CONTACT

+886-2-2312-3456pftang@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2007

Last Updated

September 15, 2005

Record last verified: 2005-06

Locations

TW(1)