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.
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.
Parallel
Upper limb exoskeleton-assisted therapy
Procedure/SurgeryThe 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 therapies
Procedure/SurgeryThe 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
Procedure/SurgeryIn 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).
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.
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.
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.
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.
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