The comparative effects of comprehensive protocol and routine physical therapy on pain, balance, disability and quality of life in patient with chronic ankle instability
To compare the effects of comprehensive physiotherapy protocol and conventional physiotherapy on pain, range of motion, balance, disability and activity level, and treatment effectiveness in patients with chronic ankle instability
Design
The clinical trial consists two arm parallel group, randomized trial with blinded postoperative care and outcome assessment. randomization was based on random numbers which was in sealed opaque.
Settings and conduct
This research project was conducted in two hospitals of Ghaem and Imam Reza in Mashhad. After evaluating the inclusion criteria by a specialist physician, patients were randomly assigned into two groups: comprehensive and conventional physiotherapy. Before starting the study, the outcome assessments were performed by a physiotherapist who was unaware of the study process. In the conventional physiotherapy protocol exercise and techniques were done for ankle joint specifically. In the comprehensive physiotherapy group, in addition to special ankle techniques and exercises, techniques and exercises were also prescribed to strengthen the hip muscles.
Participants/Inclusion and exclusion criteria
Patients aged between 18-68 years with a history of unilateral chronic ankle instability identified by a validated Persian version of the Ankle Instability Instrument (AII).
Pain, disability, balance, range of motion, quality of life and treatment effectiveness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180109038285N2
Registration date:2022-05-01, 1401/02/11
Registration timing:retrospective
Last update:2022-05-01, 1401/02/11
Update count:0
Registration date
2022-05-01, 1401/02/11
Registrant information
Name
Maryam Daghiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3752 9812
Email address
maryamdaghiyani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
2018-07-01, 1397/04/10
Actual recruitment end date
2020-06-30, 1399/04/10
Trial completion date
2020-07-31, 1399/05/10
Scientific title
The comparative effects of comprehensive protocol and routine physical therapy on pain, balance, disability and quality of life in patient with chronic ankle instability
Public title
The comparative effects of comprehensive protocol and routine physical therapy on pain, balance, disability and quality of life in patient with ankle sprain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of unilateral chronic ankle instability
Answer “yes” to at least five Yes/No questions of 9 questions of Persian-version of ankle instability instrument
Age between 18-68 year
Exclusion criteria:
severe or constant pain and swelling
radicular pain from the lumbar or buttock region
history of lower extremity surgery
lower extremity fracture
ankle fracture or surgery
Age
From 18 years old to 68 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
in order to have equal number of participants, the random allocation of participants into two groups utilized the balanced block randomization method.
In the present study, block randomization was run within blocks of four, there are six possible ways to equally assign participants to a block (A: intervention group; B: control group). All possible modes of the four blocks were written and numbered as follows: 1. AABB; 2. ABAB; 3. BBAA; 4. BABA; 5. ABBA; 6. BAAB. Consequently, in each block, two participants were assigned to the intervention group and two were assigned to the comparison group. The allocation sequence was prepared using the randomizer.org website before starting the study, with letter A for the intervention group and the letter B for the control group. The allocation sequence was prepared using the randomizer.org website before starting the study, with letter A for the intervention group and the letter B for the control group.
In order to conceal the allocation sequence, 60 opaque envelopes were prepared.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was performed in a double-blind manner so that the physiotherapist who performed the pre- and post-test was not involved in the treatment process, and in addition the person who analyzed the data was blind from the grouping allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
National Institute for medical research Development (NIMAD)
Secondary trial Id
IR.NIMAD.REC.1397.008
Registration date
2018-07-01, 1397/04/10
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of National Institute for Medical Research Development
Street address
West Fatemi Street
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.NIMAD.REC.1397.008
Health conditions studied
1
Description of health condition studied
Chronic ankle instability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Disability
Timepoint
Before starting physiotherapy and after completing physiotherapy sessions
Method of measurement
FAAM and FAOS questionnaires
Secondary outcomes
1
Description
Pain
Timepoint
Pre-intervention and immediately after finishing the physiotherapy sessions
Method of measurement
Visual Analog Scale
2
Description
Range of motion
Timepoint
Pre-intervention and immediately after physiotherapy sessions
Method of measurement
Calibrated goniometer
3
Description
Balance
Timepoint
Pre-intervention and immediately after physiotherapy sessions
Method of measurement
Star excursion balance test
4
Description
Treatment effectiveness
Timepoint
Immediately after the physiotherapy sessions
Method of measurement
Global rating of change
Intervention groups
1
Description
Intervention group: It involved up to twelve face-to-face sessions over four weeks and each session last for approximately 45 minutes. Patients in the comprehensive group, during the four-week program, received a combination of specific exercises modified from updated evidence-based randomized controlled trials and conventional physiotherapy protocol
Category
Rehabilitation
2
Description
Intervention group: It involved up to twelve face-to-face sessions over four weeks and each session last for approximately 45 minutes. Patients in the conventional group received exercises from standard physiotherapy which has been done in most randomized controlled trials elaborated in recent systematic reviews. Ankle strengthening (isometric, concentric, eccentric, weight bearing, and non-weight bearing), stretching, and retraining exercise and talocrural and subtalar mobilization were done each session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Dr. Hossein Negahban
Street address
Ghaem hospital, Ahmad abad Ave, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9596126532
Phone
+98 51 3752 9810
Email
maryamdaghiani@yahoo.com
2
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr. Ahmad Ajvadi
Street address
Emam Reza squ
City
mashhad
Province
Razavi Khorasan
Postal code
9691236532
Phone
+98 51 3842 9092
Email
maryamdaghiyani@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Hossein Negahban
Street address
No. 21, Beginning of Besat St., West Fatemi St., Tehran, Iran National Institute for Development of Medical Research (NIMAD)
City
Tehran
Province
Tehran
Postal code
99191-91778
Phone
+98 21 6693 8037
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Negahban
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khorasan Razavi, Mashhad, Azadi Square, east door of the university campus
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
honegahban@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Negahban
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Khorasan Razavi, Mashhad, Azadi Square, east door of the university campus
City
ئشسااشی
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
honegahban@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Daghiani
Position
MSc of physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
No 42, la'l Ave 4, Pardis Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3752 9812
Fax
Email
maryamdaghiyani@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the assessed outcome after publishing the article, is available
When the data will become available and for how long
Start of access period 6 months after printing
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to find a better way to treat ankle sprains, the data will be used after the article is published.
From where data/document is obtainable
Dr. Hossein Neghaban
honegahban@yahoo.com
What processes are involved for a request to access data/document
If the applicant needs the data, he / she will receive the data after giving an electronic message to Dr. Hossein Neghaban, and at his / her discretion.