NCT06211387

Brief Summary

to determine the supplementary effects of Kaltenborn sustained stretch mobilization when combined with resistance training in the management of knee osteoarthritis.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

January 8, 2024

Last Update Submit

October 1, 2024

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (8)

  • Knee Pain

    Knee Pain will be quantified using Numeric Pain Rating Scale (NPRS). NPRS is a 11 point scale form 0-10. Lower Score on NPRS signifies less pain, whereas higher score on NPRS signifies more pain.

    4 weeks

  • Physical Function

    To determine the physical function related to knee osteoarthritis Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be used with a total of 24 items and a higher score on WOMAC signifies poor outcome.

    4 weeks

  • Isometric Muscle Strength

    Modified Sphygmomanometer will be used to measure isometric muscle strength of the muscles of the knee joint. A higher score signifies greater strength.

    4 weeks

  • Functional Mobility strength

    5 repetition sit to stand test will be used to determine functional mobility strength. Less time to complete the task signifies better outcome.

    4 weeks

  • Cadence

    Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.

    4 weeks

  • Gait velocity

    Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.

    4 weeks

  • Stride length

    Observational gait analysis will be used to determine cadence. A higher score signifies better outcome.

    4 weeks

  • Knee range of motion (ROM)

    Gonimeter will be used to measure knee range of motion.. A higher score signifies better outcome.

    4 weeks

Study Arms (2)

Resistance exercise + joint mobilization

EXPERIMENTAL
Procedure: Resistance Exercise TrainingProcedure: Joint Mobilization

Resistance Exercise

ACTIVE COMPARATOR
Procedure: Resistance Exercise Training

Interventions

Resistance Exercise TrainingPROCEDURE

Resistance Exercise Training for knee

Resistance ExerciseResistance exercise + joint mobilization
Joint MobilizationPROCEDURE

Tibiofemoral and Patellofemoral Joint Mobilization

Resistance exercise + joint mobilization

Eligibility Criteria

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

You may qualify if:

  • Grade I-III knee OA Both male and female nee osteoarthritis for at least 3 months knee pain no more than 8/10

You may not qualify if:

  • Malignancy Any additional Inflammatory disorders Infection Knee trauma lower limb fracture Lumbar radiculopathy or myelopathy knee surgery Intra-articular steroid therapy in the last 2 months Total knee replacement (TKR). Total hip replacement (THR). Any neurological disorder Any cardio-pulmonary complications Rheumatoid arthritis Septic arthritis Recent history of trauma Osteoporosis or osteomyelitis Grade IV osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 66000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anas Hameed

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

  • Muhammad Osama

    Foundation University Islamabad

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

October 1, 2024

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

October 3, 2024

Record last verified: 2024-10

Locations

PA(1)