- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06754241
Impact of Personalized Rehabilitation Guidance
December 23, 2024 updated by: Yan Dong
Impact of Personalized Rehabilitation Guidance Based on WeChat Official Accounts Platform on Functional Recovery and Quality of Life of Patients with Knee Osteoarthritis
To investigate the impact of personalized rehabilitation guidance based on the WeChat Official Accounts Platform on the functional recovery and quality of life of patients with knee osteoarthritis (KOA).Ninety patients diagnosed with KOA undergoing joint replacement were included via convenient sampling.The patients were randomly divided into an observation group and a control group,with 45 patients in each group.The control group received traditional rehabilitation guidance,while the observation group received personalized rehabilitation guidance through the WeChat Official Accounts Platform in addition to the traditional guidance.Different care plans had varying effects on patients' scores on the 36-item Short Form Health Survey (SF-36),Visual Analog Scale (VAS),and Lysholm Knee Scoring Scale.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anhui
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Fuyang City, Anhui, China, 236000
- Fuyang Hospital Of Anhui Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- aged 50 to 80 years;
- conscious, without cognitive impairments, and able to complete reading independently or with assistance;
- able to operate a smartphone and use WeChat;
- willing to participate in this study and provide signed informed consent.
Exclusion Criteria:
- acute cerebrovascular disease with sequelae in the past 6 months;
- coexisting primary psychiatric disorders;
- unable to perform physical exercise due to physical disability in the lower limbs;
- postoperative complications, such as deep vein thrombosis or infection;
- participation in other interventional studies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
|
(1) Preoperative education: An appropriate walking aid was provided for the patient and instructions were given to guide correct use, while isometric muscle exercises were taught.
(2) Postoperative care: Six hours after anesthesia recovery, the head of the patient's bed could be elevated as needed, and the patient was instructed to perform ankle pumps (dorsiflexion and plantarflexion of the ankle).(3)
Postoperative exercise: One to two days after surgery, following the removal of the drainage tube, the patient was encouraged to continue with ankle pumps and isometric quadriceps contractions, as well as to begin straight-leg raises.
(4) Postoperative Day 3: In strict accordance with medical advice and under the guidance of a physiotherapist, patients engaged in continuous passive motion therapy for the affected knee, along with manual knee joint massage.
(5) Postoperative Days 5-7: the patient would try to stand with the assistance of a walker, gradually progressing to walking exercises
|
|
Experimental: observation group
|
(1) Intervention Day 1: (i) All patients in the observation group were provided with an introduction to the study and invited to join the WeChat group for the observation group.
(2) Intervention Day 2: Exercise guidance for patients with KOA was shared via the WeChat group.(3)
Intervention Day 3: Guidance for emotional regulation was sent to the patients with KOA via the WeChat group.(4)
Intervention Week 1: A micro-lesson on KOA-related knowledge was delivered via the WeChat group to deepen patients' understanding.
(5) Intervention Week 2: (i) Text instructions and related questions on common conservative treatments for KOA, including topical and oral painkillers, were shared, with correct answers provided the next day.(ii)
A micro-lesson on exercise guidance for patients with KOA was uploaded to the WeChat group to reinforce patients' understanding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The 36-item Short Form Health Survey (SF-36)
Time Frame: at 1 week and 1 month post-discharge
|
The SF-36 is a concise health survey divided into 8 subscales: physical function, role physical, bodily pain, global health, vitality, social function, role emotional, and mental health, where a higher score indicates a better health status.
|
at 1 week and 1 month post-discharge
|
|
Visual Analog Scale (VAS)
Time Frame: at 1 week and 1 month post-discharge
|
The VAS was used to assess pain levels before and after treatment in the two groups.
VAS scores are positively correlated with pain intensity, where 0 indicates no pain and 10 indicates the most severe pain.
A score of ≤3 is defined as mild pain, 4-6 as moderate pain, and ≥7 as severe pain.
|
at 1 week and 1 month post-discharge
|
|
Lysholm Knee Scoring Scale
Time Frame: at 1 week and 1 month post-discharge
|
The Lysholm Knee Scoring Scale was employed to evaluate knee function.
This scale covers eight aspects, including limping, support, restraining, instability, pain, swelling, climbing stairs, and squatting.
It is scored on a scale of 0 to 100.
The total score is 100 points, with higher scores indicating fewer symptoms and higher levels of functioning.
A score above 95 is considered excellent, 85-94 is good, 65-84 is fair, and less than 65 is poor.
|
at 1 week and 1 month post-discharge
|
|
The Newcastle Satisfaction with Nursing Scale (NSNS)
Time Frame: at 1 week and 1 month post-discharge
|
The Newcastle Satisfaction with Nursing Scale (NSNS) was used to measure patient satisfaction with nursing care.
This scale consists of 19 items, such as nurse competence, communication, emotional support, and safety management.
Each item is rated on a scale of 1-5, with a total score ranging from 19 to 95 points.
A score of ≥77 indicates very satisfied, 58-76 indicates satisfied, 39-57 indicates moderately satisfied, and ≤38 indicates dissatisfied.
|
at 1 week and 1 month post-discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
August 15, 2024
Study Completion (Actual)
September 1, 2024
Study Registration Dates
First Submitted
December 18, 2024
First Submitted That Met QC Criteria
December 23, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 23, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fuyang Affiliated Hospital 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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