NCT00184431

Brief Summary

The aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable

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

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.5 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 18, 2011

Status Verified

October 1, 2011

Enrollment Period

4 years

First QC Date

September 15, 2005

Last Update Submit

October 17, 2011

Conditions

Cerebrovascular Accident

Keywords

Cerebrovascular AccidentPhysical Therapy TechniquesMusculoskeletal EquilibriumRehabilitation

Outcome Measures

Primary Outcomes (1)

  • The Berg Balance Scale

    Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up

Secondary Outcomes (10)

  • Mini Mental State Examination

    Inclusion

  • Scandinavian Stroke Scale

    Inclusion

  • Motor Assessment Scale

    Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  • Timed Up and Go

    Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  • Step Test

    Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up

  • +5 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Intensive task specific balance training

Behavioral: Physical therapy technique and exercises

B

ACTIVE COMPARATOR

Traditional physical therapy

Behavioral: Physical therapy technique and exercises

Interventions

Physical therapy technique and exercisesBEHAVIORAL

The experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period.

AB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted to the stroke unit with a diagnosis of stroke
  • Living in the city of Trondheim
  • Included 4 - 14 days after first sign of symptoms
  • Modified Rankin Scale \> 3 before admission to hospital
  • Scandinavian Stroke Scale (SSS) less than 58 points and more than 14 points
  • SSS leg item less than 6 points or SSS movement item less than 12 points
  • Discharged to home or a rehabilitation clinic
  • Mini Mental State Examination Score more than 20 points
  • Able and willing to provide informed consent

You may not qualify if:

  • Seriously heart- and lung-diseases
  • Other diseases which makes it difficult to evaluate the function
  • Already included in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Science and Technology

Trondheim, Trondheim, 7004, Norway

Location

Related Publications (1)

  • Askim T, Morkved S, Engen A, Roos K, Aas T, Indredavik B. Effects of a community-based intensive motor training program combined with early supported discharge after treatment in a comprehensive stroke unit: a randomized, controlled trial. Stroke. 2010 Aug;41(8):1697-703. doi: 10.1161/STROKEAHA.110.584284. Epub 2010 Jun 17.

    PMID: 20558830RESULT

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy ModalitiesExercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Bent Indredavik, assoc-prof

    Department of Neuroscience, Faculty of Medicine, Norwegian university of Science and Technology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

April 1, 2004

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

NO(1)