1. Home
  2. Approved trials
  3. » فارسی

The effect of proprioceptive exercises on pain, balance and risk of falling in the military elderly with knee osteoarthritis; A Randomized Clinical Trial

Protocol summary

Study aim
The purpose of study is to investigate of the effect of proprioceptive exercises on pain, balance and risk of falling in the military elderly with knee osteoarthritis
Design
Randomized, controlled, single blinded trial
Settings and conduct
The study involves 60 elderly military with knee osteoarthritis at Baqiyatullah University of Medical Sciences. After randomization, patients are placed in one of two intervention or control groups. According to previous studies, a handbook will be used to teach traditional exercise programs of physiotherapy to knee osteoarthritis patients. In the intervention group will be taught a protocol of proprioceptive exercises. All exercises will be performed and taught under the supervision of a physiotherapist. Participants will perform these exercises three times a day for 15 repetitions each for six weeks, followed by two weeks of follow-up.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Military seniors in the age group of 55 to 75 years. 2- Patients with unilateral or bilateral knee osteoarthritis based on clinical and radiological examination. 3- Patients who present for more than 3 months with symptoms such as pain, joint stiffness, functional disability, decreased muscle strength, and limitations in daily activities. 4- Numerical pain rating scale (VAS) between 1 and 5. 5- Kellgren and Lawrence grading scale (K/L) 2 and 3 Exclusion criteria: 1- Patients with a history of or undergoing treatment with any intra-articular injection into the knee joint. 2- Muscle strength of the lower limb is less than grade 3. 3- People's unwillingness to continue testing.
Intervention groups
There are two groups (Intervention group: proprioceptive exercises with conventional therapeutic exercises, and Control group: Only conventional therapeutic exercises)
Main outcome variables
1-pain intensity. 2-risk of falling. 3-balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190322043099N1
Registration date: 2023-03-09, 1401/12/18
Registration timing: prospective

Last update: 2023-03-09, 1401/12/18
Update count: 0
Registration date
2023-03-09, 1401/12/18
Registrant information
Name
Arsalan Ghorbanpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
ghorbanpoura@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of proprioceptive exercises on pain, balance and risk of falling in the military elderly with knee osteoarthritis; A Randomized Clinical Trial
Public title
The effect of proprioceptive exercises in the military elderly with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Military seniors in the age group of 55 to 75 years. Having a body mass index (BMI) between 25 and 30. Patients with unilateral or bilateral knee osteoarthritis based on clinical and radiological examination. Having a doctor's prescription stating that the rehabilitation intervention is suitable and potentially useful. Patients who present for more than 3 months with symptoms such as pain, joint stiffness, functional disability, decreased muscle strength, and limitations in daily activities. Numerical pain rating scale between 1 and 5. Kallgren and Lawrence grading scale (K/L) 2 and 3.
Exclusion criteria:
Presence of rheumatoid arthritis, polyarthritis, or systemic inflammatory arthritis. Patients with mental defects or taking psychoactive drugs that disrupt the balance. Patients with neurological diseases (stroke, cognitive disorders, cerebellar problems, peripheral vascular conditions, and cerebrovascular diseases). Presence of any ear disorder (especially vertigo or vestibular disorder) affecting balance. Patients with a history of knee, hip, or ankle surgery. Patients with a history of or undergoing treatment with any intra-articular injection into the knee joint. Muscle strength of the lower limb is less than grade 3. People's unwillingness to continue testing.
Age
From 55 years old to 75 years old
Gender
Male
Phase
3
Groups that have been masked
  • Investigator
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly divided into three groups by closed envelope method. The allocation of the subjects will be concealed by using sequentially numbered, sealed and opaque envelopes. On the first day of treatment, the envelope allocated will be opened by participant.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor Blind: Data safety will be ensured by assigning Specific Identity numbers and all consent, readings forms will be placed in locker to bind Assessors
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.BMSU.BAQ.REC.1401.094

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain intensity
Timepoint
before intervention, after six weeks, and after two weeks follow up
Method of measurement
Visual Analogue Scale (VAS)

2

Description
Risk of falling
Timepoint
before intervention, after six weeks, and after two weeks follow up
Method of measurement
Self-efficacy questionnaire of fear of falling among the elderly

3

Description
Balance
Timepoint
before intervention, after six weeks, and after two weeks follow up
Method of measurement
1- Berg Balance Scale. 2- Timed Up and Go test.

Secondary outcomes

1

Description
Disability index
Timepoint
before intervention, after six weeks, and after two weeks follow up
Method of measurement
Knee injury and Osteoarthritis Outcome Score; KOOS

2

Description
The level of quality of life of military seniors
Timepoint
before intervention, after six weeks, and after two weeks follow up
Method of measurement
36-Item Short Form Survey (SF-36)

Intervention groups

1

Description
Intervention group: proprioceptive exercises with conventional therapeutic exercises. Proprioceptive Exercises: 1- One-Leg Balance, 2- Toe Walking, 3- Heel Walking, 4- Blind Advanced One-Leg Balance
Category
Rehabilitation

2

Description
Control group: Conventional therapeutic exercises. Conventional therapeutic Exercises: 1- Isometric Quadriceps Exercises, 2- Sitting Knee Extension Exercises, 3- Straight Leg Raise Exercises, 4- Hamstring stretching Exercises, 5- Hip Abduction and Extension Exercises
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Vahid Sobhani
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4408
Email
sobhani518@gmail.com
Web page address
https://research.bmsu.ac.ir/portal/home/?239518/%D9%85%D8%B1%DA%A9%D8%B2-%D8%AA%D8%AD%D9%82%DB%8C%D9%82%D8%A7%D8%AA-%D9%81%DB%8C%D8%B2%DB%8C%D9%88%D9%84%D9%88%DA%98%DB%8C-%D9%88%D8%B1%D8%B2%D8%B4

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Abbas Ali Imani Fooladi
Street address
Baqiyatallah University, Third Floor, Vice-Chancellor for Research and Technology, Sheikh Bahai St, Mulla Sadra St,Vanak Square
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5250
Email
imanifouladi.a@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vahid Sobhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4408
Email
sobhani518@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Vahid Sobhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
MollaSadra street , Vanak Square , Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4408
Email
sobhani518@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Arsalan Ghorbanpour
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 6586
Email
ghorbanoura@razi.tums.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...