Adhesive Capsulitis of the ShoulderNCT07482189
Effectiveness and Efficiency of an Upper Limb Active-Passive Exoskeleton Robot in Patients With Frozen Shoulder
A study testing Upper limb exoskeleton-assisted therapy, General physical therapies and Traditional physical therapies in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Frozen shoulder, also known as adhesive capsulitis, is a common chronic shoulder disorder with symptoms including shoulder pain, limitations in both active and passive range of motion, and muscle weakness, which significantly affects daily functional abilities. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder, Frozen Shoulder
- What is being tested?
- Upper limb exoskeleton-assisted therapy, General physical therapies and Traditional physical therapies
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- 1. Patients aged 20 years or older diagnosed by a clinician with primary or secondary frozen shoulder or adhesive capsulitis:
- Patients diagnosed by a clinician with frozen shoulder or adhesive capsulitis in the stiff phase.
- The patient has a loss of at least 50% of passive joint range of motion (including of shoulder flexion, abduction, internal rotation, and external rotation) on the affected shoulder compared to the relatively healthy shoulder.
Who cannot join
- Individuals with osteoarthritis or other skeletal conditions of the shoulder joint.
- Individuals with any contraindications to treatment, such as joint fusion, severe osteoporosis, or symptoms of any peripheral nerve compression.
- Individuals with untreated joint dislocations, fractures, or tendon ruptures.
- Individuals who have received steroid injections within the month prior to the study.
- Individuals who are uncommunicated or cognitively impaired.
- Pregnant women.
- Patients who refuse recruitment will also be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Frozen shoulder, also known as adhesive capsulitis, is a common chronic shoulder disorder with symptoms including shoulder pain, limitations in both active and passive range of motion, and muscle weakness, which significantly affects daily functional abilities. The investigator applied upper limb exoskeleton-assisted therapy. This experiment used a randomized controlled trial to assess the clinical rehabilitation effects of exoskeleton-assisted range of motion and resistance training on patients with frozen shoulder.
Read the detailed description
Frozen shoulder, also known as adhesive capsulitis, is often described as a common chronic shoulder disorder where the course may last from several months to years, which significantly affects daily functional abilities and mental health due to shoulder pain, limitations in both active and passive range of motion, and muscle weakness. The therapeutic standard requires extensive intervention, and generally, physical therapy is the most widely used, evidence-supported, and non-invasive treatment. The common treatments are manual joint mobilization, range of motion exercises, and resistance training, but the therapeutic outcome largely depends on the therapist's professional skills and time investment, which can impose a considerable workload on clinicians.
In previous applications, they proposed that exoskeleton robots can provide healthcare professionals with a standardized tool to assist in therapy and thereby reduce clinical workload. Other studies have predominantly focused on patients with neurological conditions, such as stroke, though exoskeleton robots have also been applied clinically in the rehabilitation of patients with adhesive capsulitis. However, systematic evidence regarding their clinical use and rehabilitation outcomes remains limited. We will conduct a randomized controlled trial to investigate the efficacy of exoskeleton-assisted therapy on frozen shoulder. 40 participants will be randomized into two groups: one is traditional active-passive exercises and theraband-based resistance training combined with conventional physical therapy (control group) and the other one is upper limb active-passive exoskeleton-assisted range of motion and resistance training combined with conventional physical therapy (experimental group). The intervention will last for four weeks, with at least three sessions per week, each lasting approximately 60-75 minutes.
The outcome measurement tools including the Visual Analogue Scale (VAS) for pain, active and passive shoulder range of motion, shoulder muscle strength (measured using a handheld dynamometer), and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire were used to compare two groups with regard to the rehabilitation outcomes and sustained effects after a two-week follow-up period in subjects with frozen shoulder.
- Being tested
- Upper limb exoskeleton-assisted therapy, General physical therapies, Traditional physical therapies
- Keywords
- Frozen shoulder, Adhesive capsulitis, Exoskeleton robots, Robot-assisted rehabilitation, Rehabilitation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb exoskeleton-assisted therapyProcedure or surgery
The upper limb exoskeleton robot used is the NimBo joint mobility robot (FREE Bionics), paired with a tablet. In this treatment, the exoskeleton assists subjects in performing shoulder range of motion training (flexion, abduction, internal and external rotation), passive stretching (flexion, extension, abduction, internal and external rotation), and muscle strength training including both isometric and isotonic contractions. The movements are performed in a sitting position, with repetitions, hold times, and rest intervals carefully structured. Joint angles are determined based on the patient's tolerance and pain level. The exoskeleton intervention lasts for 15 to 20 minutes per session, with joint angles determined based on the patient's tolerance and pain level. And it is conducted at least 3 times a week for 4 weeks.
General physical therapiesProcedure or surgery
The general physical therapies include manual joint mobilization (Maitland oscillatory techniques applied to the glenohumeral joint) and conventional physical therapy modalities such as thermotherapy, infrared therapy, IFC, TENS. The treatment session lasts 45-60 minutes and is conducted at least 3 times weekly for 4 weeks.
Traditional physical therapiesProcedure or surgery
In this arm, the subjects will receive the intervention of traditional active-assisted/passive exercises, resistance training at least 3 times a week for 4 weeks, in total at least 12 times treatments (approximately 15 to 20 minutes per session).
| Study group | Role | What they receive |
|---|---|---|
| Upper limb exoskeleton-assisted therapy combine with general physical therapy | Experimental | In this treatment, subjects perform exoskeleton-assisted shoulder range of motion (ROM) training, passive stretching, and resistance training. The movements encompass shoulder flexion, abduction, internal rotation, and external rotation. The exoskeleton intervention lasts for 15 to 20 minutes per session, with joint angles determined based on the patient's tolerance and pain level. The general physical therapies will be combined with upper limb exoskeleton-assisted therapy. And general physical therapies include manual joint mobilization (Maitland oscillatory techniques applied to the glenohumeral joint) and conventional physical therapy modalities such as thermotherapy, infrared therapy, interferential current therapy (IFC), transcutaneous electrical nerve stimulator (TENS). The treatment session lasts 45-60 minutes. Totally, there will 60-75 minutes, and at least 3 times treatments a week for 4 weeks, in total at least 12 times treatments. Receives: Procedure: General physical therapies; Procedure: Traditional physical therapies |
| Traditional physical therapies combine with general physical therapy | Active comparator | In this arm, the subjects will receive the intervention of traditional active-assisted/passive exercises, resistance training at least 3 times a week for 4 weeks, in total at least 12 times treatments (approximately 15 to 20 minutes per session). The general physical therapies will be combined with traditional physical therapies. And general physical therapies include manual joint mobilization (Maitland oscillatory techniques applied to the glenohumeral joint) and conventional physical therapy modalities such as thermotherapy, infrared therapy, IFC, TENS. The treatment session lasts 45-60 minutes. Totally, there will 60-75 minutes, and at least 3 times treatments a week for 4 weeks, in total at least 12 times treatments. Receives: Procedure: Upper limb exoskeleton-assisted therapy; Procedure: General physical therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder joint Range of Motion
Besides shoulder pain, a key clinical manifestation of shoulder adhesive capsulitis is the progressive limitation of active and passive joint range of motion, which significantly impacts daily living functions. Shoulder joint range of motion can be considered an indicator of treatment effectiveness in frozen shoulder patients. A plastic universal goniometer is a commonly used tool for measuring range of motion. It can be used to measure joint range of motion on various joints. We used this simple tool to measure the anterior flexion, extension, abduction, external rotation, and internal rotation angles of the subject's shoulder joint.
Measured: 1 day
Secondary outcomes (3)
Subjective Pain Intensity: Visual Analog Scale (VAS)
Participants were asked to describe the intensity of their current shoulder pain or soreness. Pain intensity was expressed using the visual analog scale. The visual analog scale is a tool for assessing pain intensity based on the participant's self-reported pain levels and is widely used in clinical practice to track improvements in musculoskeletal pain. Visual analog scale is evaluated using a 10-cm ruler. Patients move an indicator between a "smiley face" (indicating no pain) and a "grimacing face" (indicating extreme, unbearable pain) to reflect their current pain level. The researcher then records the corresponding 0-10 cm score from the back of the ruler.
Measured: 1 day
Muscle strength of shoulder joint
In the clinical manifestations of shoulder adhesive capsulitis, the progressive limitation of active joint range of motion is partly due to insufficient muscle strength. However, the pain in shoulder adhesive capsulitis patients often causes muscle spasms and weakness in the muscles around the affected shoulder, which may also exacerbate the pain and further restrict movement and function. Therefore, the muscle strength of the shoulder joint can also be considered one of the indicators of the cure of shoulder adhesive capsulitis patients. Strength of the shoulder flexors, extensors, abductors, and internal/external rotators is evaluated using a handheld dynamometer. Subjects are verbally encouraged to "push as hard as possible," maintaining a maximum voluntary isometric contraction for 3 seconds. The final recorded value (in pounds) is the average of three trials, with a 1-minute rest interval between each trial.
Measured: 1 day
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
The Arm, Shoulder, and Hand Disability questionnaire has been widely used for patients with various upper limb disorders. This questionnaire is reliable and effective for patient populations with various upper limb disorders. The questionnaire mainly consists of a 30-item disability/symptom scale. The questionnaire evaluates upper extremity disability and symptoms using a 30-item module, with each item scored from 1 to 5. A valid total score requires completing at least 27 items. The final score is calculated using the formula: [(sum of all completed responses / number of completed items) - 1] × 25. Higher scores indicate greater symptom severity and functional impairment.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482189
- Sponsor's protocol ID
- CMUH114-REC2-178
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Efficiency of an Upper Limb Active-Passive Exoskeleton Robot in Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT07482189
- Acronym / sponsor ID
- CMUH114-REC2-178
- Keywords
- Frozen shoulder, Adhesive capsulitis, Exoskeleton robots, Robot-assisted rehabilitation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 19 Mar 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.
Frozen shoulder, also known as adhesive capsulitis, is a common chronic shoulder disorder with symptoms including shoulder pain, limitations in both active and passive range of motion, and muscle weakness, which significantly affects daily functional abilities. The investigator applied upper limb exoskeleton-assisted therapy. This experiment used a randomized controlled trial to assess the clinical rehabilitation effects of exoskeleton-assisted range of motion and resistance training on patients with frozen shoulder.
Detailed description
Frozen shoulder, also known as adhesive capsulitis, is often described as a common chronic shoulder disorder where the course may last from several months to years, which significantly affects daily functional abilities and mental health due to shoulder pain, limitations in both active and passive range of motion, and muscle weakness. The therapeutic standard requires extensive intervention, and generally, physical therapy is the most widely used, evidence-supported, and non-invasive treatment. The common treatments are manual joint mobilization, range of motion exercises, and resistance training, but the therapeutic outcome largely depends on the therapist's professional skills and time investment, which can impose a considerable workload on clinicians.
In previous applications, they proposed that exoskeleton robots can provide healthcare professionals with a standardized tool to assist in therapy and thereby reduce clinical workload. Other studies have predominantly focused on patients with neurological conditions, such as stroke, though exoskeleton robots have also been applied clinically in the rehabilitation of patients with adhesive capsulitis. However, systematic evidence regarding their clinical use and rehabilitation outcomes remains limited. We will conduct a randomized controlled trial to investigate the efficacy of exoskeleton-assisted therapy on frozen shoulder. 40 participants will be randomized into two groups: one is traditional active-passive exercises and theraband-based resistance training combined with conventional physical therapy (control group) and the other one is upper limb active-passive exoskeleton-assisted range of motion and resistance training combined with conventional physical therapy (experimental group). The intervention will last for four weeks, with at least three sessions per week, each lasting approximately 60-75 minutes.
The outcome measurement tools including the Visual Analogue Scale (VAS) for pain, active and passive shoulder range of motion, shoulder muscle strength (measured using a handheld dynamometer), and the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire were used to compare two groups with regard to the rehabilitation outcomes and sustained effects after a two-week follow-up period in subjects with frozen shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper limb exoskeleton-assisted therapy combine with general physical therapy | Experimental | Procedure: General physical therapies, Procedure: Traditional physical therapiesIn this treatment, subjects perform exoskeleton-assisted shoulder range of motion (ROM) training, passive stretching, and resistance training. The movements encompass shoulder flexion, abduction, internal rotation, and external rotation. The exoskeleton intervention lasts for 15 to 20 minutes per session, with joint angles determined based on the patient's tolerance and pain level. The general physical therapies will be combined with upper limb exoskeleton-assisted therapy. And general physical therapies include manual joint mobilization (Maitland oscillatory techniques applied to the glenohumeral joint) and conventional physical therapy modalities such as thermotherapy, infrared therapy, interferential current therapy (IFC), transcutaneous electrical nerve stimulator (TENS). The treatment session lasts 45-60 minutes. Totally, there will 60-75 minutes, and at least 3 times treatments a week for 4 weeks, in total at least 12 times treatments. |
| Traditional physical therapies combine with general physical therapy | Active comparator | Procedure: Upper limb exoskeleton-assisted therapy, Procedure: General physical therapiesIn this arm, the subjects will receive the intervention of traditional active-assisted/passive exercises, resistance training at least 3 times a week for 4 weeks, in total at least 12 times treatments (approximately 15 to 20 minutes per session). The general physical therapies will be combined with traditional physical therapies. And general physical therapies include manual joint mobilization (Maitland oscillatory techniques applied to the glenohumeral joint) and conventional physical therapy modalities such as thermotherapy, infrared therapy, IFC, TENS. The treatment session lasts 45-60 minutes. Totally, there will 60-75 minutes, and at least 3 times treatments a week for 4 weeks, in total at least 12 times treatments. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -
- 1. Patients aged 20 years or older diagnosed by a clinician with primary or secondary frozen shoulder or adhesive capsulitis:
- Patients diagnosed by a clinician with frozen shoulder or adhesive capsulitis in the stiff phase.
- The patient has a loss of at least 50% of passive joint range of motion (including of shoulder flexion, abduction, internal rotation, and external rotation) on the affected shoulder compared to the relatively healthy shoulder.
Key exclusion criteria (7 listed)
- Individuals with osteoarthritis or other skeletal conditions of the shoulder joint.
- Individuals with any contraindications to treatment, such as joint fusion, severe osteoporosis, or symptoms of any peripheral nerve compression.
- Individuals with untreated joint dislocations, fractures, or tendon ruptures.
- Individuals who have received steroid injections within the month prior to the study.
- Individuals who are uncommunicated or cognitively impaired.
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 |
|---|---|---|
| Upper limb exoskeleton-assisted therapyThe upper limb exoskeleton robot used is the NimBo joint mobility robot (FREE Bionics), paired with a tablet. In this treatment, the exoskeleton assists subjects in performing shoulder range of motion training (flexion, abduction, internal and external rotation), passive stretching (flexion, extension, abduction, internal and external rotation), and muscle strength training including both isometric and isotonic contractions. The movements are performed in a sitting position, with repetitions, hold times, and rest intervals carefully structured. Joint angles are determined based on the patient's tolerance and pain level. The exoskeleton intervention lasts for 15 to 20 minutes per session, with joint angles determined based on the patient's tolerance and pain level. And it is conducted at least 3 times a week for 4 weeks. | Procedure or surgery | Traditional physical therapies combine with general physical therapy |
| General physical therapiesThe general physical therapies include manual joint mobilization (Maitland oscillatory techniques applied to the glenohumeral joint) and conventional physical therapy modalities such as thermotherapy, infrared therapy, IFC, TENS. The treatment session lasts 45-60 minutes and is conducted at least 3 times weekly for 4 weeks. | Procedure or surgery | Traditional physical therapies combine with general physical therapy, Upper limb exoskeleton-assisted therapy combine with general physical therapy |
| Traditional physical therapiesIn this arm, the subjects will receive the intervention of traditional active-assisted/passive exercises, resistance training at least 3 times a week for 4 weeks, in total at least 12 times treatments (approximately 15 to 20 minutes per session). | Procedure or surgery | Upper limb exoskeleton-assisted therapy combine with general physical therapy |
Primary outcome
Shoulder joint Range of Motion
Time frame: 1 day
Besides shoulder pain, a key clinical manifestation of shoulder adhesive capsulitis is the progressive limitation of active and passive joint range of motion, which significantly impacts daily living functions. Shoulder joint range of motion can be considered an indicator of treatment effectiveness in frozen shoulder patients. A plastic universal goniometer is a commonly used tool for measuring range of motion. It can be used to measure joint range of motion on various joints. We used this simple tool to measure the anterior flexion, extension, abduction, external rotation, and internal rotation angles of the subject's shoulder joint.
3 secondary outcomes
Subjective Pain Intensity: Visual Analog Scale (VAS)
Time frame: 1 day
Muscle strength of shoulder joint
Time frame: 1 day
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb exoskeleton-assisted therapy, General physical therapies and Traditional physical therapies in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by China Medical University Hospital 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li-Wei Chou, MD, PhD (+886-4-22053366 ext. 7305/ 7301, chouliwe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder joint Range of Motion (time frame: 1 day). 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 25 Mar 2026.