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Effects of a progressive balance training program with and without medial wedge on postural control of patients with chronic ankle instability

Protocol summary

Study aim
Effects of a progressive balance training program (PBTP) with and without medial wedge on postural control of patients with chronic ankle instability (CAI)
Design
Clinical trial with control group, single-blind, randomized by block method, on 24 patients
Settings and conduct
Faculty of Rehabilitation of Tehran University of Medical Sciences, 24 patients with CAI, after examining the inclusion and exclusion criteria, were randomly divided into two groups of intervention and control and underwent 12 sessions of therapeutic intervention every other day for 4 weeks. Evaluation is done before the intervention, after the end of each 3 sessions of the intervention and after 12 sessions of the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with CAI; 20- 40 yrs, Normal range of motion in trunk and lower extremity joints, Patient has a history of at least one lateral ankle sprain, The initial sprain must have occurred at least 12 months prior to study enrollment, The patient has experienced frequent ankle joint giving way, CAIT: score of ≤ 25, FAAM: activities of daily living subscale <90%, sport subscale <80% Exclusion criteria: Mechanical ankle instability, Flat foot and any structural deformity in lower limb or spine, Cardio-pulmonary disease, head trauma, numbness of the limbs, dizziness and headache, The subject has received an ankle rehabilitation program in the last 6 weeks, History of the visual, hearing and somatosensory problem, History of lower extremity injury or lower-extremity surgery
Intervention groups
The intervention group receives PBTP with insole with 4 degree medial wedge at rear foot and The control group received PBTP alone.
Main outcome variables
Static postural control, Dynamic postural control، Symmetry limb index، Duration of maintenance in the single-leg squat test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220212054006N1
Registration date: 2022-03-26, 1401/01/06
Registration timing: prospective

Last update: 2022-03-26, 1401/01/06
Update count: 0
Registration date
2022-03-26, 1401/01/06
Registrant information
Name
Makan Piri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3332 1098
Email address
mpiri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a progressive balance training program with and without medial wedge on postural control of patients with chronic ankle instability
Public title
Effects of a progressive balance training program with and without medial wedge on chronic ankle instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic ankle instability; 20- 40 yrs. Normal range of motion in trunk and lower extremity joints Patient has a history of at least one lateral ankle sprain was associated with inflammatory symptoms like pain or swelling and created at least one day interruption of physical activity The initial sprain must have occurred at least 12 months prior to study enrollment The patient has experienced frequent ankle joint giving way (at least twice in the 6 months prior to this study) Cumberland Ankle Instability Tool: score of ≤ 25 Foot and Ankle Ability Measure: activities of daily living subscale <90%, sport subscale <80%
Exclusion criteria:
Mechanical ankle instability Flat foot and any structural deformity in lower limb or spine (Medium and severe flat foot are exclude from the study) Cardio-pulmonary disease, head trauma, numbness of the limbs, dizziness and headache The subject has received an ankle rehabilitation program in the last 6 weeks History of the visual, hearing and somatosensory problem can affect the balance History of lower extremity injury or lower-extremity surgery
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using random allocation software based on random blocking method with a size of 4 blocks and a 1: 1 allocation ratio
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind, as he or she does not know how subjects are assigned to the groups and what treatment intervention each group receives.
Placebo
Not used
Assignment
Parallel
Other design features
This study has a progressive balance training program protocol with and without medial wedge for patients with chronic ankle instability

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Department of Physiotherapy, School of Rehabilitation, Pich Shemiran, Enghelab St, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.TUMS.FNM.REC.1400.236

Health conditions studied

1

Description of health condition studied
chronic ankle instability
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot

Primary outcomes

1

Description
Static postural control by measuring the center of pressure parameters
Timepoint
Before the intervention, after the end of 3 sessions of the intervention, after the end of the 12 sessions of the intervention
Method of measurement
Force plate and insert in formula

2

Description
Dynamic postural control by measuring the reaching distance in the Y balance test
Timepoint
Before the intervention, after the completion of 12 intervention sessions
Method of measurement
Tape and insert in the formula

3

Description
Symmetry limb index
Timepoint
Before the intervention, after the completion of 12 intervention sessions
Method of measurement
Tape and insert in the formula

4

Description
Duration of maintenance in the single-leg squat test
Timepoint
Before the intervention, after the completion of 12 intervention sessions
Method of measurement
Stopwatch

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The intervention group receives progressive balance training with insole with 4 degree medial wedge at rear foot for twelve sessions every other day for four weeks (3 sessions of intervention per week). The insole used in this research is semi-rigid. The superficial layer of insole is made of artificial leather with a thickness of one millimeter, the bottom layer of insole is made of cow leather with a thickness of three millimeter and the medial wedge is made of hard plastic (polyethylene).
Category
Rehabilitation

2

Description
Control group: The control group received progressive balance training for twelve sessions every other day for four weeks (3 intervention sessions per week).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic, School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Dr Mohsen Mir
Street address
Faculty of Rehabilitation, Tehran University of Medical Sciences, Enghelab St, Pich Shemiran, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
makanpiri77@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
Vice Chancellor for Research and Technology, Sixth floor, University Central Organization, Corner of Ghods Street, Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Makan Piri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 9, West Arghavan Dead End, Arash Alley, Boostan avenue, Emam Khomeini Blvd, Mehrshahr, Karaj
City
karaj
Province
Alborz
Postal code
3186619144
Phone
+98 26 3332 1098
Email
makanpiri77@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Kazem Malmir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, School of Rehabilitation, Pich Shemiran, Enghelab St, Tehran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
kmalmir@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Makan Piri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 9, West Arghavan Dead End, Arash Alley, Boostan avenue, Emam Khomeini Blvd, Mehrshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3186619144
Phone
+98 26 3332 1098
Fax
Email
makanpiri77@gmail.com

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
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
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
Data can be shared after people are not identified
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Anyone interested can access the data
Under which criteria data/document could be used
The use of data is permitted provided the source is cited if the information is used elsewhere
From where data/document is obtainable
Makan Piri, makanpiri77@gmail.com
What processes are involved for a request to access data/document
All they have to do is send email and they will receive the information within a month
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