The effect of treadmill exercise with conventional physical therapy on the spatiotemporal parameters of the gait in subjects with bilateral moderate knee osteoarthritis
To determine the effect of treadmill exercise with conventional physiotherapy on the spatiotemporal parameters of the gait in subjects with Bilateral Moderate Knee OsteoArthritis
Design
Clinical trial of parallel intervention and control groups, sample size of 50 subjects, randomized, double blinded
Settings and conduct
Therapeutic study; at physical therapy section of Emam Mosa Kazem hospital and Muscoloskeletal Research Center at Isfahan University of Medical Sciences. The participants, the assessor, the therapist and the analyzer will be blinded to the study groups. Data collection before & immediately after 10 sessions of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Age 40-70 years
2.Bilateral moderate KOA
3.Stable baseline blood pressure
Exclusion criteria:
1.Any uncontrolled metabolic, neurological (i.e. stroke, Parkinson, etc), cardiovascular problem that limits subjects ability to walk or cause gait abnormality.
2.Lower body fracture within 6 months.
3.Lower limb arthroplasty
4.Any acquired or congenital musculoskeletal dysfunction in lower limbs
5.Intra-articular steroid or hylan G-F 20 injection within the previous 6 months.
6.Inability to walk on a treadmill without an assistive device
7.History of any joint inflammatory disease.
8.Involvement in another treatment program or study protocol.
9.Involvement in any rehabilitation program within 6 months.
10.Patellofemoral dysfunction and acute low back pain
Intervention groups
All subjects will take part in conventional physical therapy program 3times a week, every other day for 10 sessions including: ultrasound, acupuncture TENS, moist hot pack, education (using an illustrated pamphlet) and setting exercise. The intervention group will have an additional exercise.
The effect of treadmill exercise with conventional physical therapy on the spatiotemporal parameters of the gait in subjects with bilateral moderate knee osteoarthritis
Public title
The effect of treadmill exercise in subjects with bilateral knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40-70 years old
Suffering from bilateral moderate knee osteoarthritis
Stable baseline blood pressure
Exclusion criteria:
Any uncontrolled metabolic, neurological (i.e. stroke, Parkinson, etc) or any cardiovascular problem that limit subjects ability to walk or cause any gait abnormality
Any altered sensation or nerve damage over the anterior knee( due to precaution in use of electrical currents like TENS)
Lower body fracture within 6 months
History of arthroplasty in either lower limbs
Presence of any acquired or congenital musculoskeletal dysfunction in lower limbs
Major loss of vision
Intra-articular steroid or hylan G-F 20 injection within the previous 6 months
Presence of a severe medical condition that precluded safe participation in an exercise or gait program
Inability to walk on a treadmill without an assistive device
History of any joint inflammatory disease
Involvement in another treatment program or study protocol
Involvement any rehabilitation program within 6 months
Acute low back pain or patellofemoral disorders
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization base on random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
The selected individuals will be informed about the study protocol in detail. They know that they will randomly be assigned into one of two groups that both will receive conventional physical therapy. They do not have the idea that by 50% they may be included in treadmill protocol. they only know that the exercise program is different between groups and there is 50% chance to be included in each group. they will be treated in the same place but not at the same time. Therefore, they do not have the opportunity to meet or observe the difference between groups. They do not know what kind of exercises are different between groups thus they will be blinded to groups' differences.
The principal investigator (PI) will assign participant into treatment and control groups based on random number table. Employed physical therapist, who has no role in subjects evaluation, will manage both groups by a conventional physical therapy program.
The same researcher who is blinded to study groups, will evaluate the subjects before and after 10 sessions of treatments in both groups. Data will be coded by PI and will be analysed by a analyzer who is blind to the study protocol.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University Of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-7346
Approval date
2017-07-29, 1396/05/07
Ethics committee reference number
IR.MUI.REC.1396.3.309
Health conditions studied
1
Description of health condition studied
Bilateral Moderate Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Spatio-temporal parameters of gait include stride length; normalized stride length; average walking speed; cadence;stance time; stance percentage.
Timepoint
Before and after 10 sessions of interventions in each groups
Method of measurement
Qualysis track manager
Secondary outcomes
1
Description
Pain
Timepoint
Before and after 10 sessions of interventions in each groups
Method of measurement
Visual analog scale(VAS); Intermittent and Constant Osteoarthritis Pain Score (ICOAP); Knee injury and Osteoarthritis Outcome Score (KOOS).
2
Description
Function
Timepoint
Before and after 10 sessions of interventions in each groups
Method of measurement
Knee injury and Osteoarthritis Outcome Score(KOOS); Six minute walk test and Get up and go test
3
Description
Gait biomechanics (kinetics and kinematics) parameters
Timepoint
Before and after 10 sessions of interventions in each groups
Method of measurement
Qualysis track system and visual 3D software
Intervention groups
1
Description
Intervention group: Ultrasound (1 MHz, 1.5-2 W, 5 minutes, continuous) that covers the antero-medial and antro-lateral aspects of the knee around the patella. Acupuncture TENS (low rate: 2-10 HZ, 200-300 microsecond, 20 minutes), four electrodes over the superior and inferior medial and lateral poles of the patella. Hot moist pack for 20 minute. Quadriceps setting. Setting of the vastus medialis oblique (VMO). Education using an illustrated pamphlet. walking on the treadmill including one minutes walking with self-selected velocity [Warm-Up period], five minutes walking with gradual increase in velocity to reach threshold heart rate at the end of 5 minute. Threshold heart rate may be calculated as HRThreshold =70%HRMax where HRMax = 220-age, seven minutes walking with controlling velocity to preserve participant’s heart rate at threshold heart rate, one minute walking: self-selected velocity [Active Recovery] and five minutes rest at sitting position [Passive Recovery].
Category
Rehabilitation
2
Description
Control group: Ultrasound (1 MHz, 1.5-2 W, 5 minutes, continuous) 1-2 minute per 1 cm2 that covers the antero-medial and antro-lateral aspects of the knee around the patella. Acupuncture TENS (low rate: 2-10 HZ, 200-300 microsecond, 20 minutes), four electrodes over the superior and inferior medial and lateral poles of the patella. Hot moist pack for 20 minute. Quadriceps setting. Setting of the vastus medialis oblique (VMO). Education using an illustrated pamphlet.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Zahra Sadat Rezaeian
Position
PhD, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Musculoskeletal Research Center, Department of Physical Therapy, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.
Department of Physical Therapy, Muscoloskeletal Research Center, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jarib Ave.