NCT06130774

Brief 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. 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

November 9, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

osteoarthritisretrowalkingbalancegait

Outcome Measures

Primary Outcomes (3)

  • 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

    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),

    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.

    six weeks

Study Arms (2)

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.

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)

Other: conventional therapy

Interventions

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

Retro walking and conventional

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)

conventional therapy

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 )
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international hospital Sihala

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

November 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations