NCT03304561

Brief Summary

Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

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

October 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2017

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

October 4, 2017

Last Update Submit

January 31, 2018

Conditions

Keywords

kneerehabilitationACLContralateral training

Outcome Measures

Primary Outcomes (1)

  • quadriceps and hamstring muscle strenght

    quadriceps strength change during the first, second and sixth months of the rehabilitation proccess after ACL reconstruction surgery. the strength measurements will conducted on isokinetic dynamometer (isomed 2000)

    6 month

Secondary Outcomes (1)

  • functional outcomes

    6 month

Study Arms (2)

traditional rehabilitation

EXPERIMENTAL

patients in this groups is going to recieve traditional rehabilitation programme for 3 months after ACL recontsruction

Other: Traditional rehabilitation

Cross-over training

EXPERIMENTAL

patients in this programme is going to recieve isokinetic exercise programme targeting unilvolved limb during rehabilitation. for the first 4 weeks after ACL reconstruction traditional rehabiitation programme is going to applied to the subjects. after 4 weeks, isokinetic strenghtening programme at 60˚/second angular velocity, between 0-90 degree knee flexion until 3 months after ACL reconstructon

Other: Cross-over training

Interventions

traditional ACL rehabilitation program

Also known as: Standard post-operative ACL rehabilidation program
traditional rehabilitation

Cross-over training addition to the traditional rehabilidation

Cross-over training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • having surgery of ACL reconstruction on one side
  • having no problem at least six month on the nonsrgical side
  • recieving the rehabilitation programme at hacettepe university, physiotherapy department

You may not qualify if:

  • refusing to include to the study
  • having revision ACL surgery
  • addition of PCL or cartilage surgery addition to the ACL surgery
  • not participating to the rehabilidation program regularly over 3 month after sugery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Physiotherapy Unit

Ankara, 06100, Turkey (Türkiye)

Location

Study Officials

  • volga tunay, PhD

    volgamel@yahoo.com

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 9, 2017

Study Start

October 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 30, 2017

Last Updated

February 5, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations