Musculoskeletal DisordersNCT07355595
Mobile App-Assisted Home Exercise for Musculoskeletal Disorders
A study testing Mobile App-Assisted Home Exercise with Standard Physiotherapy and Traditional Home Exercise with Standard Physiotherapy in people with Musculoskeletal Disorders and Low Back Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Disorders, Low Back Pain, Neck Pain
- What is being tested?
- Mobile App-Assisted Home Exercise with Standard Physiotherapy and Traditional Home Exercise with Standard Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jan 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Mobile App-Assisted Home Exercise Program on Clinical Outcomes in Patients With Musculoskeletal Disorders
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:
Read more
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.
Read the detailed description
Background: Musculoskeletal disorders are a leading cause of disability worldwide. Exercise prescription is a cornerstone of musculoskeletal rehabilitation, and physiotherapists often provide home-based exercise programs as part of self-management strategies. This approach is not only an active adjunctive intervention but also cost-effective. However, according to the 2021 Taiwan National Health Interview Survey, 54% of adults did not meet the World Health Organization's recommended physical activity levels-significantly higher than the global average of 27%-highlighting the low adherence to unsupervised exercise among Taiwanese adults. With the advancement of technology, electronic health (e-Health) interventions have become increasingly prevalent. Smartphone applications can provide reminders, recording, and personalized designs to improve adherence and clinical outcomes. Nonetheless, systematic reviews have reported that most commercially available apps have limited coverage of behavior change intervention functions (BCIFs) and lack rigorous scientific validation, leaving their clinical efficacy and large-scale applicability uncertain. Youdon, a mobile app developed by Meike Tech in Taiwan, aims to enhance accessibility and adherence to home exercise programs among Taiwanese patients. Despite its comprehensive behavior change functions, the app's clinical effectiveness remains to be verified through scientific research.
Purpose: This study aims to investigate the clinical effectiveness of a mobile app-assisted home exercise program in patients with musculoskeletal disorders, through two complementary components:
- A randomized controlled trial (RCT) comparing pain and functional outcomes between app-assisted and non-assisted home exercise programs.
- A retrospective observational study analyzing app-user data to evaluate real-time pain changes before and after exercise and their associated factors.
Methods:
Part I: A single-blind randomized controlled trial will recruit 30 participants aged 18 years and above presenting with neck, shoulder, low back, or knee pain. Participants will be randomly assigned to either an app-assisted group or a control group without app support. Both groups will receive a 4-week intervention consisting of weekly physiotherapy sessions and daily 10-minute home exercises. Primary outcomes include pain intensity, Patient-Specific Functional Scale (PSFS) scores, and region-specific disability indices; the secondary outcome is exercise adherence. Measurements will be conducted at baseline, week 2, and week 4. Data will be analyzed using an intention-to-treat approach and mixed ANOVA to examine time and group effects (p < 0.05).
Part II: A retrospective observational study will analyze approximately 700,000 anonymized data entries from the Youdon database between July 1, 2024, and August 30, 2025. The study will assess real-time changes in pain before and after each exercise session and identify influencing factors under routine clinical conditions. Data will be analyzed using linear mixed-effects models (LMMs), with participant ID set as a random intercept to account for within-subject variability.
Model 1 (Pain improvement model): The dependent variable will be the pain change score; predictors include functional diagnosis, number of pain sites, pre-exercise pain score, and exercise adherence.
Model 2 (Adherence model): The dependent variable will be exercise adherence; predictors include number of pain sites, pre-exercise pain, number of exercise prescriptions, and perceived exertion. Both models will adjust for age and sex as covariates.
- Conditions
- Musculoskeletal Disorders, Low Back Pain, Neck Pain, Shoulder Pain, Knee Pain
- Being tested
- Mobile App-Assisted Home Exercise with Standard Physiotherapy, Traditional Home Exercise with Standard Physiotherapy
- Keywords
- e-Health, Mobile Applications, Home Exercise Program
- Medical subject headings
- Musculoskeletal Diseases, Low Back Pain, Neck Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile App-Assisted Home Exercise with Standard PhysiotherapyBehavioural
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 PhysiotherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Traditional Home Exercise with Standard Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Measured using the Numeric Rating Scale, where scores range from 0 (no pain) to 10 (worst possible pain)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 2, and Week 4
Secondary 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.
Measured: Daily for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start15 Jan 2026
- Primary completion30 Jul 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy Tzyy-Jiuan Wang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355595
- Sponsor's protocol ID
- NYCU114207AE
- Status last verified
- Oct 2026
- First submitted
- 5 Jan 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data. The decision may be re-evaluated upon study completion or at the time of publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mobile App-Assisted Home Exercise Program on Clinical Outcomes in Patients With Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT07355595
- Acronym / sponsor ID
- NYCU114207AE
- Conditions
- Musculoskeletal Disorders, Low Back Pain, Neck Pain, Shoulder Pain, Knee Pain
- Keywords
- e-Health, Mobile Applications, Home Exercise Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Musculoskeletal disorders are a leading cause of disability worldwide. Exercise prescription is a cornerstone of musculoskeletal rehabilitation, and physiotherapists often provide home-based exercise programs as part of self-management strategies. This approach is not only an active adjunctive intervention but also cost-effective. However, according to the 2021 Taiwan National Health Interview Survey, 54% of adults did not meet the World Health Organization's recommended physical activity levels-significantly higher than the global average of 27%-highlighting the low adherence to unsupervised exercise among Taiwanese adults. With the advancement of technology, electronic health (e-Health) interventions have become increasingly prevalent. Smartphone applications can provide reminders, recording, and personalized designs to improve adherence and clinical outcomes. Nonetheless, systematic reviews have reported that most commercially available apps have limited coverage of behavior change intervention functions (BCIFs) and lack rigorous scientific validation, leaving their clinical efficacy and large-scale applicability uncertain. Youdon, a mobile app developed by Meike Tech in Taiwan, aims to enhance accessibility and adherence to home exercise programs among Taiwanese patients. Despite its comprehensive behavior change functions, the app's clinical effectiveness remains to be verified through scientific research.
Purpose: This study aims to investigate the clinical effectiveness of a mobile app-assisted home exercise program in patients with musculoskeletal disorders, through two complementary components:
- A randomized controlled trial (RCT) comparing pain and functional outcomes between app-assisted and non-assisted home exercise programs.
- A retrospective observational study analyzing app-user data to evaluate real-time pain changes before and after exercise and their associated factors.
Methods:
Part I: A single-blind randomized controlled trial will recruit 30 participants aged 18 years and above presenting with neck, shoulder, low back, or knee pain. Participants will be randomly assigned to either an app-assisted group or a control group without app support. Both groups will receive a 4-week intervention consisting of weekly physiotherapy sessions and daily 10-minute home exercises. Primary outcomes include pain intensity, Patient-Specific Functional Scale (PSFS) scores, and region-specific disability indices; the secondary outcome is exercise adherence. Measurements will be conducted at baseline, week 2, and week 4. Data will be analyzed using an intention-to-treat approach and mixed ANOVA to examine time and group effects (p < 0.05).
Part II: A retrospective observational study will analyze approximately 700,000 anonymized data entries from the Youdon database between July 1, 2024, and August 30, 2025. The study will assess real-time changes in pain before and after each exercise session and identify influencing factors under routine clinical conditions. Data will be analyzed using linear mixed-effects models (LMMs), with participant ID set as a random intercept to account for within-subject variability.
Model 1 (Pain improvement model): The dependent variable will be the pain change score; predictors include functional diagnosis, number of pain sites, pre-exercise pain score, and exercise adherence.
Model 2 (Adherence model): The dependent variable will be exercise adherence; predictors include number of pain sites, pre-exercise pain, number of exercise prescriptions, and perceived exertion. Both models will adjust for age and sex as covariates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-Assisted Group | Experimental | Behavioral: Mobile App-Assisted Home Exercise with Standard PhysiotherapyParticipants 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 |
| Control Group | Active comparator | Behavioral: Traditional Home Exercise with Standard PhysiotherapyParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile App-Assisted Home Exercise with Standard PhysiotherapyParticipants 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 | Behavioural | App-Assisted Group |
| Traditional Home Exercise with Standard PhysiotherapyParticipants 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 | Behavioural | Control Group |
Primary outcome
Pain Intensity
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Exercise Adherence
Time frame: Daily for 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data. The decision may be re-evaluated upon study completion or at the time of publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile App-Assisted Home Exercise with Standard Physiotherapy and Traditional Home Exercise with Standard Physiotherapy in people with Musculoskeletal Disorders and Low Back Pain, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline, Week 2, and Week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.