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Active, not recruitingNCT06741033Updated Dec 18, 2024

Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial KO

An interventional study of Conventional physiotherapy and Toe-in gait modification in Knee Osteoarthritis, sponsored by Superior University. Active, not recruiting at 1 site in Pakistan. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Superior University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Feb 2024, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
45 Years and older
Sex
All
01

Study summary

Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with medial knee OA. Rooted in biomechanical theories suggesting that altering gait patterns can reduce medial knee load, this research employs a randomized controlled trial methodology.

Read the detailed description

Participants are divided into two groups: one receiving conventional physiotherapy alone, and the other receiving a combination of conventional physiotherapy and toe-in gait modification. Outcomes are assessed over a 8-week period, focusing on pain levels and physical function. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, non-invasive intervention to alleviate symptoms and improve the quality of life for those suffering from medial knee OA. The findings could inform clinical practices and pave the way for personalized rehabilitation strategies that incorporate gait modifications, ultimately reducing the healthcare burden associated with knee osteoarthritis.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 34 is below the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Superior University is the lead sponsor of 253 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of MKOA having Grade 1-3 (radiographic evidence of MKOA)
  • Knee pain on most days of previous month. (The most symptomatic side will consider the study limb for participants with bilaterally eligible knees)
  • Age > 45
  • Ability to walk unaided for at least 25 min
  • Gender eligibility both male and female

Exclusion criteria

Exclusion Criteria:

  • Severe MKOA (Grade 4)
  • Lateral OA
  • Patella femoral OA
  • Previous or planned hip or knee surgery
  • Hip or ankle arthritis
  • Rheumatoid arthritis
  • Severe valgus and varus alignment requiring the use of an assistive device and the inability to walk independently
  • Neurological dysfunction
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Interventional group I

    Diagnostic Test: Conventional physiotherapy

  • Active comparator
    Interventional group II

    Combination Product: Toe-in gait modification

Interventions

  • Diagnostic testConventional physiotherapy

    Conventional physiotherapy of medial knee osteoarthritis patients: Isometric exercises, strengthening exercises, stretching exercises and electrotherapy.

  • Combination productToe-in gait modification

    A specific alteration in walking pattern where the toes are directed inward during walking. This modification should be clearly defined, including the degree of inward rotation of the foot and how it is taught and monitored in participants. Toe-in gait modification basically includes decrease foot progression angle from baseline through internal foot rotation. Participants are instructed to increase the Toe-in angle of their study limb by 5 degree and walk at least 5-10 minutes (progressed to 15-20 min after 4 week) with this progression angle.

06

What researchers measure

Primary outcomes

  1. NUMERIC PAIN RATING SCALE (NPRS)

    The NPRS is 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine

    Time frame: 12 Months

  2. WOMAC scale

    The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness, and Physical Function) The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.

    Time frame: 12 Months

07

Study locations

1 site
  • Institute of orthopedic and rehabilitation IOR garden town
    Lahore, Punjab Province, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in Aug 2024, 5 months.

Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 5 months is below that.

Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2024
First posted
Dec 18, 2024
StartActual
Feb 28, 2024
Primary completionActual
Aug 1, 2024
CompletionEst.
Mar 1, 2025
Last update
Dec 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06741033
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Dec 18, 2024
Start date
Feb 28, 2024
Primary completion
Aug 1, 2024
Completion
Mar 1, 2025 (estimated)
Last update
Dec 18, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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