NCT05745649

Brief Summary

Techniques used to restore the physical functions in TKR patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable knee-osteoarthritis

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

December 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

February 16, 2023

Last Update Submit

March 10, 2023

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    zero means no pain and 10 means worst type of pain

    6 weeks

  • Short form 36 Quality of life

    on zero to 100 scale. minimum means low quality of life and higher values mean better quality of life

    6 week

Study Arms (2)

Group A

EXPERIMENTAL

Resistive exercise

Other: Resistance exercises

group B

ACTIVE COMPARATOR

Ankle weights

Other: Ankle weights

Interventions

Resistance exercisesOTHER

Resistance exercises

Group A
Ankle weightsOTHER

Ankle weights

group B

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of patients above 40 years with total knee arthroplasty
  • weeks following TKR

You may not qualify if:

  • Age less than 40 patients
  • Concurrent medical disease that could affect the progress (e.g., uncontrolled hypertension, advanced malignancy, decompensated cardiovascular disease.
  • Pain score more than 6/10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rawal General & Dental Hospital

Islamabad, Federal, 44010, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A single blind RCT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A single blind RCT in which two groups were formulated. One as Control and other as an experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

February 27, 2023

Study Start

December 16, 2022

Primary Completion

February 15, 2023

Study Completion

February 16, 2023

Last Updated

March 13, 2023

Record last verified: 2023-03

Locations

PA(1)