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Clinical Trial NCT07482189 for Adhesive Capsulitis of the Shoulder, Frozen Shoulder is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effectiveness and Efficiency of an Upper Limb Active-Passive Exoskeleton Robot in Patients With Frozen Shoulder 40 Randomized
Clinical Trial NCT07482189 is an interventional study for Adhesive Capsulitis of the Shoulder, Frozen Shoulder and is currently not yet recruiting. Enrollment is planned to begin on 16 March 2026 and continue until the study accrues 40 participants. Led by China Medical University Hospital, this study is expected to complete by 15 March 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief 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. The investigator applied upper limb exoskeleton-assisted therapy. This experiment used a randomized controlled trial to assess the clinical rehabilitation eff...Show More
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 t...Show More
Official Title
Effectiveness and Efficiency of an Upper Limb Active-Passive Exoskeleton Robot in Patients With Frozen Shoulder
Conditions
Adhesive Capsulitis of the ShoulderFrozen ShoulderOther Study IDs
- CMUH114-REC2-178
NCT ID Number
Start Date (Actual)
2026-03-16
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-03-15
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Frozen shoulder
Adhesive capsulitis
Exoskeleton robots
Robot-assisted rehabilitation
Rehabilitation
Adhesive capsulitis
Exoskeleton robots
Robot-assisted rehabilitation
Rehabilitation
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalUpper limb exoskeleton-assisted therapy combine with general physical therapy 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...Show More | General physical therapies 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 therapies 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). |
Active ComparatorTraditional physical therapies combine with general physical therapy 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 t...Show More | Upper limb exoskeleton-assisted therapy 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 contr...Show More General physical therapies 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 1 day |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 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. | 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. | 1 day |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
20 Years
Eligible Sexes
All
-
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.
- 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.
Study Central Contact
Contact: Li-Wei Chou, MD, PhD, +886-4-22053366, [email protected]
Contact: Yueh-Ling Hsieh, PT, PhD, +886-4-22053366, [email protected]
1 Study Locations in 1 Countries
Wufeng Dist.
Asia University Hospital, Taichung, Wufeng Dist., 413, Taiwan