IRCT | The effect of neuromuscular exercises plus traditional exercise therapy on muscle morphology, dynamic balance and functional disability indices in people with chronic ankle instability: “A randomised controlled trial”

Protocol summary

Study aim: The effect of neuromuscular exercises plus common exercise therapy on muscle morphology, dynamic balance &functional disability indices in people with chronic ankle instability.
Design: Single blind and block randomised trial with two parallel groups.The first group is the control group which is a common physiotherapy treatment, second group is the intervention group, which is a series of neuromuscular exercises associated with the common physiotherapy treatment.
Settings and conduct: In initiation, the end of treatment& follow-up(1 month),outcomes are evaluated by sonography,Y balance test& questionnaire.According to subject's group,common physiotherapy/common physiotherapy with neuromuscular exercise are performed at the Physical Therapy Clinic of Ahvaz Rehabilitation School for 12 sessions for 4 weeks & Data analyzer will be blind of intervention type and grouping.
Participants/Inclusion and exclusion criteria: Inclusion:1.18-40 years, 2. Ability of weight bearing on the injury leg, 3.At least one inversion ankle sprain with pain/ edema& temporary loss of ankle function at 1-6 months ago, 4. Twice ankle giving way during functional activity at 6 months ago, 5.Cumberland questionnaire score <= 28, 6.Fear of ankle instability.Exclusion:1.Neurological impairments, 2.Vestibular impairments, 3.Head trauma during 3 months ago,4.Pregnancy, 5.Lower limb fracture, 6.Ankle muscle or ligament rupture, 7.Ankle surgery, 8.Musculoskeletal impairments in Lower limb joints during 3 months ago
Intervention groups: Control group:Common physical therapy exercises (resistance exercises of Tibialis anterior& Peroneus longus& balance exercises on the tilt board). Intervention group: Control group exercises plus a series of neuromuscular exercises according to Lephart protocol. 12 treatment sessions(3 sessions per week for 4 weeks).
Main outcome variables: Function;Muscle thickness;Dynamic balance

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20181216042008N1

Registration date: 2019-02-15, 1397/11/26

Registration timing: registered_while_recruiting

Last update: 2019-02-15, 1397/11/26

Update count: 0
Registration date: 2019-02-15, 1397/11/26

Registrant information: Name

Khadijeh Kazemi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 11 4426 1551

Email address

kazemi.kh@ajums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-12-22, 1397/10/01
Expected recruitment end date: 2019-12-22, 1398/10/01
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of neuromuscular exercises plus traditional exercise therapy on muscle morphology, dynamic balance and functional disability indices in people with chronic ankle instability: “A randomised controlled trial”

Public title: The effect of neuromuscular exercises plus traditional exercise therapy in people with chronic ankle instability:
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Inversion ankle sprain during 1-6 months ago Giving way of ankle during 6 months ago Fear of ankle instability Cumberland questionnaire score <= 28 Ability of weight bearing on the involved leg

Exclusion criteria:

Neurological impairments Vestibular impairments Head trauma during 3 months ago Pregnancy Lower limb fracture Ankle muscle or ligament rupture Ankle surgery Musculoskeletal impairments in Lower limb joints during 3 months ago
Age: From 18 years old to 40 years old
Gender: Both

Phase

N/A

Groups that have been masked

Data analyser

Sample size

Target sample size: 20

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization is a block randomization method. The tool used in this method is Random allocation software. In this software; random sequence is determined by specifying the number of groups(2 groups), the type of groups (intervention and control) and the sample size .

Blinding (investigator's opinion)

Single blinded

Blinding description

After data collection& entry of them in SPSS software, data file that don't contain of patient names, available to the data analyzer.The data analyzer will not be aware of the type of intervention, participants grouping& researcher hypothesis to don't create bias in statistical results interpretation.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Ahvaz Jundishapur University of Medical Sciences

Street address

Physiotherapy Department, Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway

City

َAhvaz

Province

Khouzestan

Postal code

6135715794
Approval date: 2018-10-20, 1397/07/28
Ethics committee reference number: IR.AJUMS.REC.1397.530

Health conditions studied

1

Description of health condition studied: sprain of ankle
ICD-10 code: S93.4
ICD-10 code description: Sprain of ankle

Primary outcomes

1

Description: Function
Timepoint: At the beginning of the treatment and after the 12 intervention sessions
Method of measurement: Foot and Ankle Outcome Score questionnaire

Secondary outcomes

1

Description: Dynamic balance
Timepoint: Before initiation of treatment, after the intervention sessions and one month after the end of the intervention sessions
Method of measurement: Y balance test

2

Description: Muscle thickness
Timepoint: Before initiation of treatment, after the intervention sessions(12 sessions) and one month after the end of the intervention sessions
Method of measurement: By Sonography Device

Intervention groups

1

Description: Intervention group: Common physiotherapy (Ultrasound, Infra-Red, Trans-cutaneous Electrical nerve Stimulation, Tibialis Anterior& Peroneus longus muscles Resistance exercise by Elastic band and balance exercise by tilt board) with neuromuscular exercises taken from Lephart protocol for 12 sessions,3 times a week for 4 weeks, any session time: 1h, 20 min.
Category: Rehabilitation

2

Description: Control group: Common physiotherapy (Ultrasound, Infra-Red, Trans-cutaneous Electrical nerve Stimulation, Tibialis Anterior& Peroneus longus muscles muscles Resistance exercise by Elastic band and balance exercise by tilt board) for 12 sessions,3 times a week for 4 weeks, any session time: 1h.
Category: Rehabilitation

Recruitment centers

1

Recruitment center: Name of recruitment center

Physiotherapy Clinic of Rehabilitation School

Full name of responsible person

Gholamhossein Nassadj

Street address

Rehabilitation school, Ahvaz Jundishapur university of medical sciences, Golestan Highway

City

Ahvaz

Province

Khouzestan

Postal code

6135733133

Phone

+98 61 3374 3101

Email

Ahvaz-rehab@ajums.ac.ir

1

Sponsor: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Mohammad Badavi

Street address

Ahvaz Jundishapur University of Medical Sciences, Golestan Highway

City

Ahvaz

Province

Khouzestan

Postal code

6135715794

Phone

+98 61 3336 2414

Email

itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Ahvaz 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

Ahvaz University of Medical Sciences

Full name of responsible person

Gholamhossein Nassadj

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Physiotherapy Department, Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway

City

Ahvaz

Province

Khouzestan

Postal code

6135733133

Phone

+98 61 3374 3101

Email

nassadj@yahoo.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Gholamhossein Nassadj

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Physiotherapy

Street address

Physiotherapy Department, Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway

City

Ahvaz

Province

Khouzestan

Postal code

6135733133

Phone

+98 61 3374 3101

Email

nassadj@yahoo.com

Person responsible for updating data

Contact: Name of organization / entity

Ahvaz University of Medical Sciences

Full name of responsible person

Khadijeh Kazemi

Position

PhD candidate

Latest degree

Master

Other areas of specialty/work

Physiotherapy

Street address

Physiotherapy Department, Rehabilitation School, Ahvaz Jundishapur University of Medical Sciences, Golestan Highway

City

Ahvaz

Province

Khouzestan

Postal code

6135733133

Phone

+98 11 4426 1551

Fax

Email

kazemi.kh@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Not applicable
Data Dictionary: Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document: Only part of the data, such as the original outcome information, the study protocol and statistical analysis can be shared.
When the data will become available and for how long: 6 months after results publish
To whom data/document is available: Data will only be available to researchers working in academic and scientific institutes.
Under which criteria data/document could be used: If the research plan is intended to apply the therapeutic exercises used or the variables studied are similar to this study.
From where data/document is obtainable: executor of plan: Dr.Gholamhossein nassadj E-mail: nassadj@yahoo.com
What processes are involved for a request to access data/document: By sending an email with a full explanation of the reason for requesting the documentation and the purpose of having it.
Comments

The effect of neuromuscular exercises plus traditional exercise therapy on muscle morphology, dynamic balance and functional disability indices in people with chronic ankle instability: “A randomised controlled trial”