Effectiveness and Efficiency of an Upper Limb Active-Passive Exoskeleton Robot in Patients With Frozen Shoulder

China Medical University

Status: Not yet enrolling

Conditions: Adhesive Capsulitis of the Shoulder; Frozen Shoulder

Treatments: Procedure: Traditional physical therapies; Procedure: Upper limb exoskeleton-assisted therapy; Procedure: General physical therapies

Study type: Interventional

Funder types: Other

Identifiers

NCT07482189

CMUH114-REC2-178

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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1. Patients aged 20 years or older diagnosed by a clinician with primary or secondary frozen shoulder or adhesive capsulitis:

1. Patients diagnosed by a clinician with frozen shoulder or adhesive capsulitis in the stiff phase.
2. 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.

Exclusion criteria

1. Individuals with osteoarthritis or other skeletal conditions of the shoulder joint.
2. Individuals with any contraindications to treatment, such as joint fusion, severe osteoporosis, or symptoms of any peripheral nerve compression.
3. Individuals with untreated joint dislocations, fractures, or tendon ruptures.
4. Individuals who have received steroid injections within the month prior to the study.
5. Individuals who are uncommunicated or cognitively impaired.
6. Pregnant women.
7. Patients who refuse recruitment will also be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Upper limb exoskeleton-assisted therapy combine with general physical therapy

Experimental group

Description:

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.

Treatment:

Procedure: General physical therapies

Procedure: Traditional physical therapies

Traditional physical therapies combine with general physical therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: General physical therapies

Procedure: Upper limb exoskeleton-assisted therapy