Protocol summary

Summary
The aim of this study is to asses the effect of neuromuscular training of intact knee on static& dynamic balance and performance of injured knee after ACL reconstructionin the present cilinical trial study , we recruite 30 patient undergoing ACL reconstruction (allograft) from chamran hospitaland allocated them randomly to the experimental or control group are randomly divided to the intervention and control group .inclusion criteria: patient with unilateral anterior cruciate ligament injury that have undergone ACL reconstruction and exclusion criteria:vestibular system disorder, orthopeadic-Rheumatologic-neurologic disorder in other joint in both extrimity, history of previous surgery in lower extrimity,lower extremity discrepancy. intervention group receive the usual rehabilitation protocol for two hours daily, 4 days per week for eight weeks and also receive intact neuromuscular training for thirty minutes daily, 4 days per week for eight week . function, static and dynamic balance is assessed by lysholm Questionnaire,Balance error scoring system,Stork stand test before surgery and eight weeks after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015032821553N1
Registration date: 2015-04-10, 1394/01/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-04-10, 1394/01/21
Registrant information
Name
Motahareh Karimi Jashni
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3735 3390
Email address
mahb_karimi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-04-09, 1394/01/20
Expected recruitment end date
2015-08-11, 1394/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neuromuscular training of intact knee on static& dynamic balance and performance of injured knee after ACLreconstruction.
Public title
the effect of training of intact knee on improvement of function of reconstructed knee.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patient with unilateral anterior cruciate ligament injury that have undergone ACL reconstruction. exclusion criteria:vestibular system disorder; orthopeadic-Rheumatologic-neurologic disorder in other joint in both extrimity; history of previous surgery in lower extrimity;lower extremity discrepancy
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences, Rehabilitation School
Street address
Shiraz School of Rehabilitation, First Abiverdi Ave, Chamran Boulevard
City
shiraz
Postal code
Approval date
2014-08-26, 1393/06/04
Ethics committee reference number
ct-9373-7143

Health conditions studied

1

Description of health condition studied
Patients with anterior cruciate ligament reconstruction
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee

Primary outcomes

1

Description
performance
Timepoint
before intervention, eight weeks after intervention
Method of measurement
lysholm Questionnaire

2

Description
static balance
Timepoint
before intervention, eight weeks after intervention
Method of measurement
Balance error scoring system,Stork stand test

3

Description
dynamic balance
Timepoint
before intervention, eight weeks after intervention
Method of measurement
star excrusion test

Secondary outcomes

1

Description
pain
Timepoint
before intervention and eight week after intervention
Method of measurement
Pain Numeric Rating Scale

Intervention groups

1

Description
control group receive the usual rehabilitation protocol for two hours daily, 4 days per week for eight weeks.
Category
Rehabilitation

2

Description
intervention group receive the usual rehabilitation protocol for two hours daily, 4 days per week for eight weeks and also receive intact neuromuscular training for thirty minutes daily, 4 days per week for eight week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Physiotherapy Center, Shiraz Chamran Hospital
Full name of responsible person
Motahareh Karimi Jashni
Street address
Chamran Physiotherapy Center, Chamran Hospital, Chamran Boulevard, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmeddini
Street address
Vice-Chancellery of Research, Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences , Rehabilitation School
Full name of responsible person
Motahareh Karimi Jashni
Position
master student of sport physiotherapy
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation, First Abiverdi Ave, Chamran Boulevard.
City
shiraz
Postal code
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
jashni9@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences , Rehabilitation School
Full name of responsible person
Dr.Fahimeh Kamali Sarvestani
Position
Phd of physiotherapy
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation, First Abiverdi Ave, Chamran Boulevard.
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
fahimehkamali@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences ,Rehabilitation School
Full name of responsible person
Motahareh Karimi Jashni
Position
master student of sport physiotherapy
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation, First Abiverdi Ave, Chamran Boulevard.
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
jashni9@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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