Mobile App-Assisted Home Exercise for Musculoskeletal Disorders

NCT07355595 | Not Yet Recruiting

• 1 other identifier: NYCU114207AE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain; Neck Pain; Shoulder Pain; Knee Pain; Musculoskeletal Disorders

Keywords

e-Health; Mobile Applications; Home Exercise Program

Outcome Measures

Primary Outcomes (6)

• Pain Intensity

  Measured using the Numeric Rating Scale, where scores range from 0 (no pain) to 10 (worst possible pain)

  Baseline, Week 2, and Week 4

• 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.

  Baseline, Week 2, and Week 4

• 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.

  Baseline, Week 2, and Week 4

• 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.

  Baseline, Week 2, and Week 4

• Shoulder Disability (Shoulder Pain and Disability Index, SPADI)

  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.

  Baseline, Week 2, and Week 4

• Knee Disability (International Knee Documentation Committee Subjective Knee Evaluation Form, IKDC)

  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.

  Baseline, Week 2, and Week 4

Secondary Outcomes (1)

• Exercise Adherence

  Daily for 4 weeks

Study Arms (2)

App-Assisted Group

EXPERIMENTAL

Participants in this group will receive a 4-week program consisting of weekly physiotherapy sessions and a daily 10-minute home exercise program assisted by a dedicated mHealth application

Behavioral: Mobile App-Assisted Home Exercise with Standard Physiotherapy

Control Group

ACTIVE COMPARATOR

Participants in this group will receive a 4-week program consisting of weekly physiotherapy sessions and a daily 10-minute traditional home exercise program without mobile application support

Behavioral: Traditional Home Exercise with Standard Physiotherapy

Interventions

Traditional Home Exercise with Standard Physiotherapy BEHAVIORAL

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

Control Group

Mobile App-Assisted Home Exercise with Standard Physiotherapy BEHAVIORAL

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

App-Assisted Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112304, Taiwan

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Low Back Pain; Neck Pain; Shoulder Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physical Therapy, National Yang Ming Chiao Tung University

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)