NCT06877845

Brief Summary

  • To assess the impact of postural corrector on post-operative knee function and activity
  • To evaluate the role of activity tracker in monitoring and enhancing post-operative rehabilitation
  • To assess the effects of postural corrector and activity tracker on pain management during rehabilitation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

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

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

March 10, 2025

Last Update Submit

February 23, 2026

Conditions

Keywords

PainKnee FunctionPost-operative Rehabilitation

Outcome Measures

Primary Outcomes (4)

  • OKS (Oxford Knee Score) to assess Function and Pain in Knee

    The OKS is a patient-reported outcome measure that is used to assess the severity of a knee problem and the effect of knee conditions on a person's life. The questionnaire has 12 questions about pain, function, and limitations in activities, and it provides doctors insight into how much a patient's knee problems are limiting daily activities. You sum the scores for all 12 questions. The scores ranges from zero to 48, zero meaning worst knee function and 48 meaning best knee function.

    12 Weeks

  • UCLA Activity Scale for assessing the Physical Activity Level of patients undergoing Knee & Hip Arthoplasty

    The UCLA Activity Scale (UCLA) is a questionnaire used to assess physical activity levels in patients undergoing hip or knee arthroplasty, ranging from 1 (low) to 10 (high), and is valuable for measuring changes in self-reported physical activity.

    12 Weeks

  • EQ-5D-5L (EuroQol 5-DIMENSION 5-Level) to measure the health-related quality of life (HRQoL)

    One popular instrument for evaluating people's health-related quality of life (HRQoL) is the EQ-5D questionnaire. The EQ-5D-5L comprises a VAS in addition to the descriptive system and index score. The VAS asks the responder to rate their general health on a scale of 0 to 100, where 100 is the best possible health and 0 is the worst possible health.

    12 Weeks

  • NPRS (NUMERIC PAIN RATING SCALE) for Pain

    A straightforward and widely used instrument for determining the degree of pain is the NPRS (Numeric Pain Rating Scale). the NPRS is used to gauge the degree of either acute or chronic pain. Using a 0-10 scale, the NPRS allows users to rate the intensity of their pain by choosing the number that most accurately represents their current level of discomfort.

    12 Weeks

Study Arms (2)

Activity Tracker & Postural Corrector

EXPERIMENTAL

Activity Tracker \& Postural Corrector along with conventional treatment

Other: Activity Tracker & Postural CorrectorOther: Conventional Therapy

Conventional Treatment

ACTIVE COMPARATOR

* HOT PACKS:for 15 minutes * TENS (transcutaneous electric nerve stimulator): for 10 minutes * ROMs(range of motions): at knee joint Passive and Active-Assisted Knee Flexion and Extension Quadriceps Sets Straight Leg Raises (SLR) Ankle Pumps * Strengthening Exercises: Quadriceps Strengthening, Hamstring Curls, Gluteal Strengthening \& Calf Raises Total Duration of Exercise Session: 25 minutes

Other: Conventional Therapy

Interventions

Use of Activity Tracker \& Postural Corrector along with following baseline treatment. * HOT PACKS:for 15 minutes * TENS (transcutaneous electric nerve stimulator): for 10 minutes * ROMs(range of motions): at knee joint Passive and Active-Assisted Knee Flexion and Extension Quadriceps Sets Straight Leg Raises (SLR) Ankle Pumps * Strengthening Exercises: Quadriceps Strengthening Hamstring Curls Gluteal Strengthening Calf Raises Total Duration of Exercise Session: 25 minutes

Activity Tracker & Postural Corrector

* HOT PACKS:for 15 minutes * TENS (transcutaneous electric nerve stimulator): for 10 minutes * ROMs(range of motions): at knee joint Passive and Active-Assisted Knee Flexion and Extension Quadriceps Sets Straight Leg Raises (SLR) Ankle Pumps * Strengthening Exercises: Quadriceps Strengthening Hamstring Curls Gluteal Strengthening Calf Raises Total Duration of Exercise Session: 25 minutes

Activity Tracker & Postural CorrectorConventional Treatment

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants who fall in this category will be included in the study.
  • Commercially available devices
  • Post-operative total knee replacement
  • Males and females
  • Age 40 to 60 years

You may not qualify if:

  • Participants who fall in this category will be excluded from the study.
  • Non wearable devices
  • Patient had been through surgery more than 1 month
  • Patients with any other disorder or disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hand Institute of Rehabilitation Sciences (HHIRS)

Mānsehra, KPK, 21300, Pakistan

Location

MeSH Terms

Conditions

Pain

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesWearable Electronic DevicesElectrical Equipment and Supplies

Study Officials

  • Ayesha Sadiq, MSPT (OMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

April 1, 2025

Primary Completion

July 11, 2025

Study Completion

December 31, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations