- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06877845
Postural Correctors & Activity Trackers in Total Knee Replacement Rehab
Effects of Postural Corrector and Activity Tracker for Enhanced Post-operative Rehabilitation of Total Knee Replacement
- 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KPK
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Mānsehra, KPK, Pakistan, 21300
- Helping Hand Institute of Rehabilitation Sciences (HHIRS)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Activity Tracker & Postural Corrector
Activity Tracker & Postural Corrector along with conventional treatment |
Use of Activity Tracker & Postural Corrector along with following baseline treatment.
Quadriceps Strengthening Hamstring Curls Gluteal Strengthening Calf Raises Total Duration of Exercise Session: 25 minutes
Quadriceps Strengthening Hamstring Curls Gluteal Strengthening Calf Raises Total Duration of Exercise Session: 25 minutes |
|
Active Comparator: Conventional Treatment
Total Duration of Exercise Session: 25 minutes |
Quadriceps Strengthening Hamstring Curls Gluteal Strengthening Calf Raises Total Duration of Exercise Session: 25 minutes |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
OKS (Oxford Knee Score) to assess Function and Pain in Knee
Time Frame: 12 Weeks
|
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
|
|
EQ-5D-5L (EuroQol 5-DIMENSION 5-Level) to measure the health-related quality of life (HRQoL)
Time Frame: 12 Weeks
|
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
Time Frame: 12 Weeks
|
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
|
|
UCLA Activity Scale for assessing the Physical Activity Level of patients undergoing Knee & Hip Arthoplasty
Time Frame: 12 Weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayesha Sadiq, MSPT (OMPT), Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-01006 Nauman Nazir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Istanbul UniversityCompleted
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Clinical Trials on Activity Tracker & Postural Corrector
-
The University of Texas Medical Branch, GalvestonCompleted
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Institut CurieCompleted
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Texas Tech UniversityCompletedPhysical Activity
-
Istituto Auxologico ItalianoRecruitingHealth BehaviorItaly
-
Maastricht University Medical CenterSt. Antonius Hospital; Gelderse Vallei Hospital; ild care foundationCompletedFatigue | Sarcoidosis
-
National Taiwan University HospitalRecruitingDepressive Disorder | Bipolar DisorderTaiwan
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Columbia UniversityCompletedPreterm Birth | Preterm DeliveryUnited States
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University of North Carolina, Chapel HillNational Institutes of Health (NIH)CompletedCardiac RehabilitationUnited States
-
Jacob E. SimmeringCompleted
-
University of MalayaUnknownSurgery | Fitness Trackers | Early Ambulation | Health Services for the AgedMalaysia