Osteo Arthritis KneeNCT06130774
Effects of Retro-walking in Patients With Knee OA
A study testing Retro walking and conventional and conventional therapy in people with Osteo Arthritis Knee, run by Riphah International University at 1 site in Pakistan.
Trial summary
Osteoarthritis is degenerative joint disease that cause deterioration of the articular cartilage and neighboring tissue and lead to osteophyte formation, weakening of surrounding muscles, ligamentous laxity and inflammation of synovium. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Retro walking and conventional and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral Knee OA .
- Kellgren-Lawrence grading (grade 1 and 2)
- Participants fulfilling three out of the six clinical criteria listed by the American College of Rheumatology The criteria are Age >40 years, Morning stiffness lasting <30 mins. Crepitus with active motion, Bony tenderness, Bony enlargement and No warmth to touch and diagnosed to have knee OA
- Pain more than 6 weeks
Who cannot join
- Trauma or surgery in the last 6 months.
- Hip, knee, and foot deformities.
- Stroke and other neurovascular issues.
- Severe pain (greater than 7 in NPRS)
- Difficulty in walking for 10 min continuously.
- Obesity (body mass index greater than 25 kg/m2 )
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- Osteoporosis
- Patients having any systemic joint pathology, inflammatory joint disease (e.g. rheumatoid arthritis, gouty arthritis, psoriatic arthritis).
- Patients who had any neurological deficit, myelopathy any mental illness.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international hospital Sihala
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effects of Retro-walking in Knee OA Along With Conventional Therapy
Osteoarthritis is degenerative joint disease that cause deterioration of the articular cartilage and neighboring tissue and lead to osteophyte formation, weakening of surrounding muscles, ligamentous laxity and inflammation of synovium. Diagnosis can be made based on history and clinical features and risk factors including age, sex, body mass index , absence of whole leg pain, fixed flexion deformity, absence of traumatic event, restricted flexion range of motion, pain in descending stairs, palpable effusion and crepitus. Confirmation is usually based on radiological finding according to Kellgren and Lawrence diagnostic scale . Radio graphic changes of osteoarthritis of the knee are bilateral in 85% of patients .
Read the detailed description
Knee pain is a major symptom of knee osteoarthritis (OA) that lead to stiffness, and capsular contracture along with muscle spasm. Decreased flexibility of muscles reduces the joint range of motion and thus contributes to increase in the stiffness of the joint lead to physical disability in persons with knee OA.Eighty percent of persons with knee OA experience pain and 25% struggle to perform activities of daily living.) Retro-walking is sometimes referred to as backward walking, has been thought to be used already for several decades in China, Japan and Europe to get a physical workout, improve sport performance, promote balance and also to stay mentally fit .
In fact in Europe, they have races which vary from sprints to the 26.2 miles marathon.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Retro walking and conventional, conventional therapy
- Keywords
- osteoarthritis, retrowalking, balance, gait
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retro walking and conventionalOther
Patient will start retro walking with first he/she will raise his/her one foot with toe off first then heel will be off from ground. swing phase of same leg would be done in backward direction with flexion on knee and extension will be performed on hip. Then patient will place the same foot on ground behind the other foot, with toe touch first on ground, and so this way patient would continue his retro-walk for 20 minutes
conventional therapyOther
Hot pack in supine lying (10min) TENS (10min ) Tibiofemoral mobilization (grade 1,2 ,3) (10rep) Static quadriceps exercise in supine (10rep x 3sec x2set) hip abduction in side lying(10repx 2set) knee bending exercise in prone lying ( 10rep x 2set) Hamstring stretch in supine ( 10 rep x 2 set)
| Study group | Role | What they receive |
|---|---|---|
| Retro walking and conventional | Experimental | Patient will start retro walking with first he/she will raise his/her one foot with toe off first then heel will be off from ground. swing phase of same leg would be done in backward direction with flexion on knee and extension will be performed on hip. Then patient will place the same foot on ground behind the other foot, with toe touch first on ground, and so this way patient would continue for 20 minutes continue his retro-walk for 20 minutes. Receives: Other: Retro walking and conventional |
| conventional therapy | Active comparator | Hot pack in supine lying (10min) TENS (10min ) Tibiofemoral mobilization (grade 1,2 ,3) (10rep) Static quadriceps exercise in supine (10rep x 3sec x2set) hip abduction in side lying(10repx 2set) knee bending exercise in prone lying ( 10rep x 2set) Hamstring stretch in supine ( 10 rep x 2 set) Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPRS
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. NPRS exhibited moderate reliability
Measured: six weeks
WOMAC
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68),
Measured: six weeks
Calcon Calculator
To calculate your walking stride length, divide the number of steps you took by two and divide that number into the measured distance. If it took you 18 steps to cover 21 feet, divide the number of steps (18) by 2 to get the number of strides. Then take the answer (9) and divide it into the distance. Distance in feet/number of strides = stride length. In this case, you took nine strides in 22 feet, so your stride length would be 2.4 feet. For step length divide the number of steps into the measured distance. Distance in feet/number of steps = step length.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria Khalid, MSOMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130774
- Sponsor's protocol ID
- REC 01681 MAIRA KANWAL
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Retro-walking in Knee OA Along With Conventional Therapy
- ClinicalTrials.gov ID
- NCT06130774
- Acronym / sponsor ID
- REC 01681 MAIRA KANWAL
- Conditions
- Osteo Arthritis Knee
- Keywords
- osteoarthritis, retrowalking, balance, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis is degenerative joint disease that cause deterioration of the articular cartilage and neighboring tissue and lead to osteophyte formation, weakening of surrounding muscles, ligamentous laxity and inflammation of synovium. Diagnosis can be made based on history and clinical features and risk factors including age, sex, body mass index , absence of whole leg pain, fixed flexion deformity, absence of traumatic event, restricted flexion range of motion, pain in descending stairs, palpable effusion and crepitus. Confirmation is usually based on radiological finding according to Kellgren and Lawrence diagnostic scale . Radio graphic changes of osteoarthritis of the knee are bilateral in 85% of patients .
Detailed description
Knee pain is a major symptom of knee osteoarthritis (OA) that lead to stiffness, and capsular contracture along with muscle spasm. Decreased flexibility of muscles reduces the joint range of motion and thus contributes to increase in the stiffness of the joint lead to physical disability in persons with knee OA.Eighty percent of persons with knee OA experience pain and 25% struggle to perform activities of daily living.) Retro-walking is sometimes referred to as backward walking, has been thought to be used already for several decades in China, Japan and Europe to get a physical workout, improve sport performance, promote balance and also to stay mentally fit .
In fact in Europe, they have races which vary from sprints to the 26.2 miles marathon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retro walking and conventional | Experimental | Other: Retro walking and conventionalPatient will start retro walking with first he/she will raise his/her one foot with toe off first then heel will be off from ground. swing phase of same leg would be done in backward direction with flexion on knee and extension will be performed on hip. Then patient will place the same foot on ground behind the other foot, with toe touch first on ground, and so this way patient would continue for 20 minutes continue his retro-walk for 20 minutes. |
| conventional therapy | Active comparator | Other: conventional therapyHot pack in supine lying (10min) TENS (10min ) Tibiofemoral mobilization (grade 1,2 ,3) (10rep) Static quadriceps exercise in supine (10rep x 3sec x2set) hip abduction in side lying(10repx 2set) knee bending exercise in prone lying ( 10rep x 2set) Hamstring stretch in supine ( 10 rep x 2 set) |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral Knee OA .
- Kellgren-Lawrence grading (grade 1 and 2)
- Participants fulfilling three out of the six clinical criteria listed by the American College of Rheumatology The criteria are Age >40 years, Morning stiffness lasting <30 mins. Crepitus with active motion, Bony tenderness, Bony enlargement and No warmth to touch and diagnosed to have knee OA
- Pain more than 6 weeks
Key exclusion criteria (9 listed)
- Trauma or surgery in the last 6 months.
- Hip, knee, and foot deformities.
- Stroke and other neurovascular issues.
- Severe pain (greater than 7 in NPRS)
- Difficulty in walking for 10 min continuously.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retro walking and conventionalPatient will start retro walking with first he/she will raise his/her one foot with toe off first then heel will be off from ground. swing phase of same leg would be done in backward direction with flexion on knee and extension will be performed on hip. Then patient will place the same foot on ground behind the other foot, with toe touch first on ground, and so this way patient would continue his retro-walk for 20 minutes | Other | Retro walking and conventional |
| conventional therapyHot pack in supine lying (10min) TENS (10min ) Tibiofemoral mobilization (grade 1,2 ,3) (10rep) Static quadriceps exercise in supine (10rep x 3sec x2set) hip abduction in side lying(10repx 2set) knee bending exercise in prone lying ( 10rep x 2set) Hamstring stretch in supine ( 10 rep x 2 set) | Other | conventional therapy |
Primary outcome
NPRS
Time frame: six weeks
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. NPRS exhibited moderate reliability
WOMAC
Time frame: six weeks
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. Higher scores indicate worse pain, stiffness, and functional limitations. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68),
Calcon Calculator
Time frame: six weeks
To calculate your walking stride length, divide the number of steps you took by two and divide that number into the measured distance. If it took you 18 steps to cover 21 feet, divide the number of steps (18) by 2 to get the number of strides. Then take the answer (9) and divide it into the distance. Distance in feet/number of strides = stride length. In this case, you took nine strides in 22 feet, so your stride length would be 2.4 feet. For step length divide the number of steps into the measured distance. Distance in feet/number of steps = step length.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maria Khalid, MSOMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retro walking and conventional and conventional therapy in people with Osteo Arthritis Knee, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPRS (time frame: six weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.