NCT00377689

Brief Summary

The purpose of this study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

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

September 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

1.6 years

First QC Date

September 15, 2006

Last Update Submit

October 27, 2008

Conditions

Cerebrovascular AccidentMusculoskeletal Equilibrium

Keywords

Accidental fallsCerebrovascular accidentBalanceADLSelf efficacyQuality of LifeGait parameters

Outcome Measures

Primary Outcomes (1)

  • Improvement in balance

    post, 3 & 6 months

Secondary Outcomes (4)

  • Reduced falls

    post, 3 & 6 months

  • Improved self-efficacy

    post, 3 & 6 months

  • Improved ADL

    post, 3 & 6 months

  • Improved walking ability

    post, 3 & 6 months

Interventions

high intensity functional exerciseBEHAVIORAL

high intensity functional exercise

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • ability to walk 10 meter with or without assistive device
  • ability to understand simple instructions

You may not qualify if:

  • TIA
  • independent in walking outdoors
  • serious visual impairment
  • serious hearing impairment
  • long distance to intervention station

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University, department of Community science and rehabilitation

Umeå, 90137, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eva Holmgren, PhD student

    Umeå University & The Vårdal Institute

    PRINCIPAL INVESTIGATOR

  • Per Wester, MD Professor

    Umeå University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 18, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

SE(1)