Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651996
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Adherence and Feasibility of Remote Rehabilitation for Chronic Patellofemoral Joint Pain a Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adherence and Feasibility of Remote Rehabilitation for Chronic Patellofemoral Joint Pain a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single-center trial involving 66 patients diagnosed with patellofemoral pain The study adhered to ethical guidelines and obtained informed consent from all participants Participants were randomly assigned to receive face-to-face remote rehabilitation guidance either 1 time 3 times or 6 times The primary outcome measure was exercise adherence assessed using the Exercise Rating Scale EARS after 6 weeks of rehabilitation Secondary outcomes included knee pain severity muscle strength knee function fatigue levels and a qualitative research questionnaire An isokinetic strength testing system was used to measure the open-chain strength of the quadriceps muscle
Detailed Description:
The inestigators conducted a forward-looking single-center pilot study with a follow-up period of 8 weeks The study recruited 66 patients diagnosed with patellofemoral pain PFP by a professional sports physician at the Department of Sports Medicine Peking University Third Hospital between January and September 2023 The study adhered to the principles of the Declaration of Helsinki and was approved by the Research Ethics Committee of Peking University Third Hospital Although this is a pilot study the inestigators strictly followed the CONSORT guidelines All participants signed an informed consent form and completed home rehabilitation interventions
Inclusion and Exclusion Criteria During the trial an investigator not involved in the study used an electronically generated random sequence to assign patients to three groups Two professional physical therapists NC and SR were responsible for assessing and supervising the accuracy of the project and were unaware of the grouping details
Interventions After randomization participants received a package containing two wearable motion sensors a charger resistance bands and a manual Additionally the rehabilitation software provided lectures and QA sessions related to the condition accessible via Android or iOS platforms All data collected by the sensors were strictly encrypted to protect patient information and privacy Each participant was assigned a therapist for home rehabilitation support and a follow-up function via the software or telephone was used to remind patients who missed three remote rehabilitation sessions
Before starting home rehabilitation patients attended a briefing at the hospital Participants were divided into three groups Group 1 received 1 face-to-face remote rehabilitation tutorial OST Group 2 received 3 face-to-face remote rehabilitation tutorials TST and Group 3 received 6 face-to-face remote rehabilitation tutorials SST Each session lasted 40 minutes and was conducted three times a week on Tuesday Thursday and Saturday Following the briefing patients performed home remote rehabilitation training on the same day with each session lasting 40 minutes The remote rehabilitation program included muscle strengthening flexibility stretching and movement quality training
Primary Outcome The primary outcome was assessed by the Exercise Adherence Rating Scale EARS 6 weeks after completing the rehabilitation guidance The scale consists of Part A which directly assesses adherence including 6 questions each with 5 options scoring from 0 to 4 and Part B which assesses reasons affecting adherence including 10 questions each with 5 options scoring from 0 to 4 Items with positive phrasing were reverse scored so a higher overall adherence score indicates better exercise adherence
Secondary Outcomes Secondary outcomes were collected at the hospital 8 weeks after the start of the study including knee pain severity assessed by the Visual Analog Scale VAS ranging from 0 no pain to 10 worst pain isokinetic concentric and eccentric peak torque of the quadriceps muscle reflecting knee joint muscle strength Kujala Patellofemoral Score 0 to 100 points with higher scores indicating better knee function and the Fatigue Severity Scale FSS which measures the severity of fatigue in patients with various conditions and its impact on activities and lifestyle including 9 questions each scored from 1 to 7 with higher scores indicating greater fatigue Additionally after completing the remote rehabilitation program the inestigators conducted a qualitative research questionnaire to explore potential strategies to improve adherence
Inclusion and Exclusion Criteria During the trial an investigator not involved in the study used an electronically generated random sequence to assign patients to three groups Two professional physical therapists NC and SR were responsible for assessing and supervising the accuracy of the project and were unaware of the grouping details
Interventions After randomization participants received a package containing two wearable motion sensors a charger resistance bands and a manual Additionally the rehabilitation software provided lectures and QA sessions related to the condition accessible via Android or iOS platforms All data collected by the sensors were strictly encrypted to protect patient information and privacy Each participant was assigned a therapist for home rehabilitation support and a follow-up function via the software or telephone was used to remind patients who missed three remote rehabilitation sessions
Before starting home rehabilitation patients attended a briefing at the hospital Participants were divided into three groups Group 1 received 1 face-to-face remote rehabilitation tutorial OST Group 2 received 3 face-to-face remote rehabilitation tutorials TST and Group 3 received 6 face-to-face remote rehabilitation tutorials SST Each session lasted 40 minutes and was conducted three times a week on Tuesday Thursday and Saturday Following the briefing patients performed home remote rehabilitation training on the same day with each session lasting 40 minutes The remote rehabilitation program included muscle strengthening flexibility stretching and movement quality training
Primary Outcome The primary outcome was assessed by the Exercise Adherence Rating Scale EARS 6 weeks after completing the rehabilitation guidance The scale consists of Part A which directly assesses adherence including 6 questions each with 5 options scoring from 0 to 4 and Part B which assesses reasons affecting adherence including 10 questions each with 5 options scoring from 0 to 4 Items with positive phrasing were reverse scored so a higher overall adherence score indicates better exercise adherence
Secondary Outcomes Secondary outcomes were collected at the hospital 8 weeks after the start of the study including knee pain severity assessed by the Visual Analog Scale VAS ranging from 0 no pain to 10 worst pain isokinetic concentric and eccentric peak torque of the quadriceps muscle reflecting knee joint muscle strength Kujala Patellofemoral Score 0 to 100 points with higher scores indicating better knee function and the Fatigue Severity Scale FSS which measures the severity of fatigue in patients with various conditions and its impact on activities and lifestyle including 9 questions each scored from 1 to 7 with higher scores indicating greater fatigue Additionally after completing the remote rehabilitation program the inestigators conducted a qualitative research questionnaire to explore potential strategies to improve adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None