Mobile App-Assisted Home Exercise for Musculoskeletal Disorders
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Yang Ming Chiao Tung University
About this trial
Overview This study evaluates the effectiveness of a dedicated mobile health (mHealth) application in supporting home exercise programs for patients with musculoskeletal disorders, such as neck, shoulder, back, or knee pain. The research aims to address the widespread challenge of low patient adherence to unsupervised home-based exercises.
Study Design The project employs a dual-methodology approach:
Clinical Trial: 30 participants presenting with neck, shoulder, back, or knee pain will be randomly assigned to either an app-assisted group or a traditional home exercise group. Both groups will undergo 4 weeks of physiotherapy. The study will compare pain intensity, physical function, and exercise adherence between the two cohorts.
Retrospective Analysis: To complement the trial, the study will analyze a large-scale database containing approximately 700,000 anonymized real-world data entries. This analysis aims to observe real-time pain fluctuations before and after exercise sessions within routine clinical settings.
Goal The primary objective is to determine if integrating mHealth technology into traditional rehabilitation can enhance clinical outcomes and improve patient adherence to home-based exercise routines.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years and above
Presenting with musculoskeletal disorders leading to pain in the neck, shoulder, low back, or knee
Scoring 3 or higher on the Numeric Pain Rating Scale
Disqualifiers
Diagnosis of malignant tumors
Presence of serious systemic or neurological conditions that may interfere with assessment or treatment, such as uncontrolled hypertension, serious cardiac diseases, or Parkinson's disease
Inability to use a mobile smartphone
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Mobile App-Assisted Home Exercise with Standard Physiotherapy
BehavioralParticipants will receive one 30-minute face-to-face physiotherapy session weekly for 4 weeks. Concurrently, they will perform a daily 10-minute home exercise program via a dedicated mobile health application that provides automated reminders, home exercise video demonstrations, self-monitoring of exercise data, tele-consultation capabilities, and patient education on pain pathology
Traditional Home Exercise with Standard Physiotherapy
BehavioralParticipants will receive one 30-minute face-to-face physiotherapy session weekly for 4 weeks. Concurrently, they will perform a daily 10-minute home exercise program based on verbal instructions provided by the physiotherapist. This group will not have access to any mobile health application or digital support
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: App-Assisted GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain Intensity
Measured using the Numeric Rating Scale, where scores range from 0 (no pain) to 10 (worst possible pain)
Time frame
Baseline, Week 2, and Week 42
Functional performance
Measured using the Patient-Specific Functional Scale (PSFS). Participants identify at least three activities that are most affected by their condition and rate their ability to perform each on an 11-point scale ranging from 0 to 10 (0 = unable to perform activity, 10 = able to perform activity without any difficulty). Higher scores indicate a better functional outcome.
Time frame
Baseline, Week 2, and Week 43
Neck Disability (Neck Disability Index, NDI)
Neck-related disability will be assessed using the Neck Disability Index (NDI). The NDI consists of 10 items, each scored on a 6-point scale ranging from 0 to 5, yielding a total score from 0 to 50. The total score will be converted to a percentage score (0-100%), with higher scores indicating a greater degree of functional disability.
Time frame
Baseline, Week 2, and Week 44
Low Back Disability (Oswestry Disability Index, ODI)
Low back-related disability will be assessed using the Oswestry Disability Index (ODI). The ODI consists of 10 items, each scored from 0 to 5, resulting in a total score ranging from 0 to 50. The total score will be converted to a percentage score (0-100%), with higher scores indicating a greater degree of functional disability.
Time frame
Baseline, Week 2, and Week 4Secondary outcomes
1
Exercise Adherence
Exercise adherence is evaluated using a standardized electronic self-report record form. All participants are required to record real-time data after each home exercise session, including the actual duration of exercise performed (excluding rest periods), pain intensity before and after exercise, and perceived exertion levels. Adherence is defined as the percentage of the actual exercise duration relative to the prescribed duration. A higher percentage reflects better adherence to the home exercise program.
Time frame
Daily for 4 weeksSponsors and contacts
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Source ClinicalTrials.gov
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