NCT00696319

Brief Summary

The study that is registered in ClinicalTrials is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The aim of the overall study is to prospectively follow a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee, in order to document results from different rehabilitation regimes after the injury. The title of the part study is 'Neuromuscular changes in ACL-deficient individuals before and after an intensive perturbation training program. A case-control study.' The aims of the part study are:

  1. 1.To describe muscle activation patterns, joint angles and forces during gait and one-legged hop in newly injured ACL-deficient individuals before and after execution of an intensive training program consisting of either perturbation training or conventional balance- and stability training
  2. 2.To describe eventual changes between the two groups that may indicate superiority of either one of the methods

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

5.4 years

First QC Date

June 9, 2008

Last Update Submit

June 30, 2011

Conditions

Keywords

Rupture of the anterior cruciate ligament of the knee

Outcome Measures

Primary Outcomes (1)

  • Biomechanical changes during walking and one-legged hop tests.

    Before and after a six week intervention.

Study Arms (2)

1

EXPERIMENTAL

Arm 1 will go through a rehabilitation protocol with perturbation training exercises.

Other: Exercise protocol with perturbation exercises.

2

EXPERIMENTAL

Arm 2 will go through a rehabilitation protocol with traditional exercises for balance and stability training.

Other: Exercise protocol with traditional exercises for stability and balance.

Interventions

Perturbation exercises are exercises for balance and stability that involves perturbations of the surface through use of custom made equipment (a rollerboard, a rockerboard and a platform).

1

The exercise protocol will consist of exercises for balance and stability that do not include sudden disturbances or perturbations to the surface.

2

Eligibility Criteria

Age13 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Verified unilateral total rupture of the ACL
  • Age 13-55 years
  • Activity level 1 or 2 (regular participation in pivoting sports)

You may not qualify if:

  • Concomitant ligamentous injury
  • Bilateral involvement
  • Symptomatic meniscal damage
  • Fractures
  • Full-thickness articular cartilage damage larger than 1 cm in diameter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Centre, Ullevaal University Hospital

Oslo, Oslo County, 0407, Norway

Location

Related Links

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • May Arna Risberg, PT, PhD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 12, 2008

Study Start

January 1, 2007

Primary Completion

June 1, 2012

Study Completion

June 1, 2013

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations