Mobile App-Assisted Home Exercise for Musculoskeletal Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

Mobile App-Assisted Home Exercise with Standard Physiotherapy: Participants 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: Participants 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

Study summary

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

Primary outcome measure(s)

• Pain Intensity — Baseline, Week 2, and Week 4
  Measured using the Numeric Rating Scale, where scores range from 0 (no pain) to 10 (worst possible pain)
• Functional performance — Baseline, Week 2, and Week 4
  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.
• Neck Disability (Neck Disability Index, NDI) — Baseline, Week 2, and Week 4
  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.
• Low Back Disability (Oswestry Disability Index, ODI) — Baseline, Week 2, and Week 4
  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.
• Shoulder Disability (Shoulder Pain and Disability Index, SPADI) — Baseline, Week 2, and Week 4
  Shoulder-related disability will be assessed using the Shoulder Pain and Disability Index (SPADI). The SPADI consists of 13 items, including 5 pain items and 8 disability items, each rated on an 11-point numeric rating scale (0-10). Item scores are summed to yield a total score ranging from 0 to 130, which is converted to a percentage score (0-100%) by dividing the total score by 130 and multiplying by 100. Higher scores indicate a greater degree of functional disability.
• Knee Disability (International Knee Documentation Committee Subjective Knee Evaluation Form, IKDC) — Baseline, Week 2, and Week 4
  Knee-related disability will be assessed using the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form. The IKDC consists of 18 items covering symptoms, sports activities, and function, of which item 10a is excluded from scoring, yielding a raw score ranging from 0 to 87. The raw score is converted to a standardized score (0-100) by dividing the total score by 87 and multiplying by 100, with higher standardized scores indicating better knee function. For analytical purposes, the standardized IKDC score will be reversed (100 - score), such that higher transformed scores indicate a greater degree of functional disability.

Trial sites (1)

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