IRCT | Comparison of the Effects of Cognitive_Balance Dual-Task Training and Single Task Balance Training on Static Balance of People with Anterior Cruciate Ligament Reconstruction (ACL

Protocol summary

Study aim: The main purposes of this study are the comparison of some of center of pressure (COP) parameters in static balance task while standing on reconstructed limb before and after intervention in each group and between groups, also survey of correlation between COP parameters and level of functional disability measured by KOOS questionnaire in people with anterior cruciate ligament reconstruction.
Design: Clinical trial with parallel control group, double blind and randomized grouping, 15 people in each group
Settings and conduct: This study will be carried out at the Biomechanics Lab of rehabilitation sciences faculty of Tabriz University of Medical Sciences. Individuals in intervention group will do progressive balance training simultaneously with cognitive tasks for 20 minutes 3 sessions a week for 6 weeks. The control group will just do balance training. Participants, researcher, and data recorder and analyzer will be blind to groups.
Participants/Inclusion and exclusion criteria: In this study the people with unilateral anterior cruciate ligament reconstructed by hamstring tendon allograft and ability of full weight bearing on reconstructed limb and at least 120 degree reconstructed knee range of motion will participate; and they will be eliminated if they have a history of neurological, vestibular and visual disorder, injury or surgery of the spine or other segments of involved limb or other ligaments of the reconstructed knee.
Intervention groups: Intervention group will do balance training and cognitive tasks simultaneously (Dual Task). However, control group will just do balance training (Single Task).
Main outcome variables: COP parameters include sway amplitude, velocity, path length and Mean Square (RMS) amplitude and velocity of COP in anterior-posterior and medial-lateral direction, total path length of COP ,Root , ellipse sway area and KOOS questionnaire score.

General information

Reason for update
Acronym: Anterior Cruciate Ligament Reconstruction (ACL_R)
IRCT registration information: IRCT registration number: IRCT20180925041138N1

Registration date: 2019-05-31, 1398/03/10

Registration timing: prospective

Last update: 2019-05-31, 1398/03/10

Update count: 0
Registration date: 2019-05-31, 1398/03/10

Registrant information: Name

Jalal Ahadi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 41 3337 5359

Email address

ahadij@tbzmed.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2019-06-22, 1398/04/01
Expected recruitment end date: 2020-03-19, 1398/12/29
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Comparison of the Effects of Cognitive_Balance Dual-Task Training and Single Task Balance Training on Static Balance of People with Anterior Cruciate Ligament Reconstruction (ACL_R)

Public title: Affect of Dual_Task Balance Training on Balance of People with Anterior Cruciate Ligament Reconstruction
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Unilateral ACL Reconstruction Surgery by Hamstring Tendon Allograft Full Weight Bearing Ability on Reconstructed limb At Least 120 Degree Reconstructed Knee Range of Motion

Exclusion criteria:

The History of Neurological, Vestibular and Visual Disorder The History of Injury or Surgery of the Spine The History of Injury or Surgery of the Other Segments of Reconstructed Limb The History of Injury or Surgery of the Other Ligaments of Reconstructed Knee
Age: From 18 years old to 45 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 30

Randomization (investigator's opinion)

Randomized

Randomization description

In this study people with inclusion criteria will be divided into control and Intervention groups according to simple randomization way by Random Software Allocation.

Blinding (investigator's opinion)

Double blinded

Blinding description

In this study all of the participants will be unaware of group of study they belong to. Also researcher, outcomes assessors and data analyzer will be unaware the group each participants belong to. Inevitably, the trainer physiotherapist base on intervention type will not be blind. However, he will not be allowed to outcome assessment and data analysis.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Tabriz University of Medical Sciences

Street address

Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5166615669
Approval date: 2019-01-21, 1397/11/01
Ethics committee reference number: IR.TBZMED.REC.1397.865

Health conditions studied

1

Description of health condition studied: Anterior Cruciate Ligament Reconstruction
ICD-10 code: S83.51
ICD-10 code description: Sprain of anterior cruciate ligament of knee

Primary outcomes

1

Description: Mean Anterior - Posterior Sway amplitude of Center of Pressure
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

2

Description: Mean Medial - Lateral Sway amplitude of Center of Pressure
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

3

Description: Total path length of Center of Pressure
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

4

Description: Root-mean-square amplitude of center of pressure in anterior - posterior direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

5

Description: Root-mean-square amplitude of center of pressure in medial - lateral direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

6

Description: Root-mean-square velocity of center of pressure in anterior - posterior direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

7

Description: Root-mean-square velocity of center of pressure in medial - lateral direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

8

Description: ٍEllipse sway area
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

9

Description: Center of pressure velocity in anterior - posterior direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

10

Description: Center of pressure velocity in medial - lateral direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

11

Description: Path length of center of pressure in anterior - posterior direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

12

Description: Path length of center of pressure in medial - lateral direction
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

Secondary outcomes

1

Description: The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Timepoint: Before starting balance training and at the end of treatment (18 session later)
Method of measurement: Force Plate Instrument

Intervention groups

1

Description: Intervention group: Anterior cruciate reconstructed patients during rehabilitation in balance training phase will do progressive balance training including single leg standing on reconstructed limb, standing on bi-direction balance board in med-lat direction, standing on bi-direction balance board in ant-post direction, standing on bi-direction balance board with foam surface(10 cm thickness), standing on multi-direction balance board, standing on multi-direction balance board with foam surface(10 cm thickness) simultaneously with cognitive tasks including backward counting of numbers at a specified interval, saying the days of the week in reverse and alternative ways, saying the names started with special letters, reverse words spelling (Dual Task) for 20 minutes, 3 sessions a week for 6 weeks.
Category: Rehabilitation

2

Description: Control group: Anterior cruciate reconstructed patients during rehabilitation in balance training phase will do progressive balance training including single leg standing on reconstructed limb, standing on bi-direction balance board in med-lat direction, standing on bi-direction balance board in ant-post direction, standing on bi-direction balance board with foam surface(10 cm thickness), standing on multi-direction balance board, standing on multi-direction balance board with foam surface(10 cm thickness) without any cognitive tasks (Single Task) for 20 minutes, 3 sessions a week for 6 weeks.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Shohada medical research & training hospital

Full name of responsible person

Dr. Amin Moradi

Street address

No. 692, Golshahr street, Elgoli Street, Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5167846171

Phone

+98 41 3389 3314

Email

info@cdrm-en.tbzmed.ac.ir

1

Sponsor: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Dr. Abolghasem Jouyban

Street address

No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Azadi Street, Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5165665931

Phone

+98 41 3335 7310

Fax

+98 41 3334 4280

Email

research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Tabriz University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Jalal Ahadi

Position

Assistance Professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Physiotherapy department, Rehabilitation Sciences Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5166615669

Phone

+98 41 3337 5359

Email

Ahadij@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Jalal Ahadi

Position

Assistance professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Physiotherapy department, Rehabilitation Sciences Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5166615669

Phone

+98 41 3337 5359

Email

Ahadij@tbzmed.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Tabriz University of Medical Sciences

Full name of responsible person

Jalal Ahadi

Position

Assistance professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Physiotherapy department, Rehabilitation Sciences Faculty, Tabriz University of Medical Sciences, Golgasht street, Azadi street, Tabriz

City

Tabriz

Province

East Azarbaijan

Postal code

5166615669

Phone

+98 41 3337 5359

Email

Ahadij@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD: There is no further information.
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: No - There is not a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available

Comparison of the Effects of Cognitive_Balance Dual-Task Training and Single Task Balance Training on Static Balance of People with Anterior Cruciate Ligament Reconstruction (ACL_R)