Protocol summary

Study aim
• To compare the Effects of open kinetic chain exercises and closed chain exercises on balance and range of motion in patients with knee osteoarthritis.
Design
Randomized clinical trial, Single-blind (outcomes assessor), on clinically diagnosed patients with knee osteoarthritis by orthopedic surgeon and radiographic imaging, 46 patients
Settings and conduct
The study will be conducted in the Outpatient Department of Physical Therapy, Chughtai Rehabilitation Unit, chughtai medical center jail road Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Patients between 45-65 years of age and suffering from knee pain for more than 3 months. • OA confirmed by radiographic imaging, Grade I and II according to Kllegren and Lawrence classification of knee OA. Exclusion criteria: • Patients suffering from degenerative diseases of other lower extremity joints. • Patients having other musculoskeletal problems with Red flag signs For instance: Osteoporosis, Paget’s disease, Rheumatoid arthritis. • Prolonged immobilization. • Patients having neurological deficits/Hemiplegics.
Intervention groups
Group 1: Patients will be asked to perform open chain exercise using cuff weights of (0.5-2.5Kg) tied on ankle or dorsum of foot in a progressive resistance training according to the strength of the patient by finding his/her 1 repetition maximum. Group 2: Patients will be asked to perform closed chain exercises including step up and step down, terminal extension in standing using therapeutic resistance band of different resistances light, medium and medium to heavy using three colours yellow, red and green respectively in standing position according to their submaximal strength in first session. Two times per week sessions of 1 month protocol will be done in weight bearing/standing position (1 set of 10 reps).
Main outcome variables
Joint range of motion; balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200513047419N1
Registration date: 2020-06-15, 1399/03/26
Registration timing: registered_while_recruiting

Last update: 2020-06-15, 1399/03/26
Update count: 0
Registration date
2020-06-15, 1399/03/26
Registrant information
Name
muhammad ehtisham ul haq raza
Name of organization / entity
Riphah international university
Country
Pakistan
Phone
+92 42 35299988
Email address
ehtisham.raza13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-20, 1399/02/31
Expected recruitment end date
2020-07-30, 1399/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of open and closed kinetic chain exercises on balance and range of motion in patients with knee osteoarthritis
Public title
Comparative study of open and closed kinetic chain exercises on balance and range of motion in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1: Patients between 45-65 years of age and suffering from knee pain for more than 3 months. Osteoarthritis confirmed by radiographic imaging, Grade I and II according to Kllegren and Lawrence classification of knee Osteoarthritis. Unilateral knee osteoarthritis. Both males and females are included in the study
Exclusion criteria:
• Patients suffering from degenerative diseases of other lower extremity joints. • Recent fractures. • Vertigo • Chronic heart disease. • Patients having other musculoskeletal problems with Red flag signs For instance: Osteoporosis, Paget’s disease, Rheumatoid arthritis. • Prolonged immobilization. • Patients having neurological deficits/Hemiplegics. • Osteoarthritis of Bilateral knee joint. • Patients who are not able to ambulate without assistive device or aid. • Patients who have received knee surgery in past 3 months. • Patients who have received intra-articular injection in last 6 weeks prior to study are excluded from research.
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into 2 groups using computer generated random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor will be kept blinded about the treatment protocols and study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethical Committee (REC) Riphah College of Rehabilitation & Allied Health Sciences
Street address
Riphah International University - Lahore Campus - 28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore, Lahore, Pakistan-54000
City
lahore
Postal code
54000
Approval date
2019-10-09, 1398/07/17
Ethics committee reference number
RCRS-RE-MS-OMPT/SPring19/033

Health conditions studied

1

Description of health condition studied
Osteoarthritis (OA) is a most common chronic degenerative joint disease, affecting weight bearing joints. It gradually leads to a disability restricting the individual from various daily functional activities. It is a combination of mechanical abnormalities characterized by degradation of articular cartilage, articulating joints and subchondral space. This damage to articular cartilage leads to fibrillation, fissures, gross ulcerations and finally disappearance of the full thickness of articular cartilage
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Balance
Timepoint
Before treatment, after 2 weeks, after 4 weeks at the end of treatment
Method of measurement
Dynamic y balance test

2

Description
Range of motion
Timepoint
Before treatment, after 2 weeks, after 4 weeks at the end of treatment
Method of measurement
Goniometer

Secondary outcomes

1

Description
Pain intensity
Timepoint
Before treatment, after 2 weeks, after 4 weeks at the end of treatment
Method of measurement
Visual analogue scale

Intervention groups

1

Description
"Intervention group 1:Open chain exercise of knee using cuff weights of (0.5-2.5Kg) tied on ankle or dorsum of foot in a progressive resistance training according to the strength of the patient by finding his/her 1 repetition maximum. Therefore, from that 1 RM by calculating 75% of its 1RM we can find its 10RM. As 75% of 1RM makes 10RM for that specific exercise. This 1 RM AND 10 RM will be found in first session only
Category
Rehabilitation

2

Description
Intervention group 2: Closed chain exercises including step up and step down, terminal extension in standing using therapeutic resistance band of different resistances light, medium and medium to heavy using three colours yellow, red and green respectively in standing position according to their submaximal strength in first session.Two times per week sessions of 1month protocol will be done in weight bearing/standing position (1 set of 10reps).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurological and physical rehabilitation unit Chughtai medical centre
Full name of responsible person
Dr Saajid Bhatti
Street address
10-jail road, main Gulberg, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 35299988
Email
Sajidbhatti@btinternet.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Danish Hassan
Street address
28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore, Pakistan
City
Lahore
Postal code
54000
Phone
Email
Admissions.lahore@riphah.edu.pk
Grant name
Danish Hassan
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
100
Public or private sector
Private
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
Riphah international university
Full name of responsible person
Dr Daanish Hassan
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
28-M Quaid-e-Azam Industrial Estate Kot Lakhpat, Lahore, Lahore, Pakistan-54000
City
Lahore
Province
Punjab
Postal code
54000
Phone
0092 42 351261108
Email
6686@vle.riphah.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah international university
Full name of responsible person
Dr Daanish Hassan
Position
Assistant professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
28-M quaied e azam industrial state lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
0092 42 351261108
Email
6686@vle.riphah.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
Rashid latif medical complex
Full name of responsible person
Muhammad Ehtisham Ul Haq
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
37-E pak arab housing society ferozepur road lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
0092 42 351261108
Email
ehtisham.raza13@yahoo.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
Undecided - It is not yet known if there will be 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
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
Not applicable
Data Dictionary
Not applicable
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