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

NCT07482189 | Not Yet Recruiting

• 1 other identifier: CMUH114-REC2-178
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 effects of exoskeleton-assisted range of motion and resistance training on patients with frozen shoulder.

Conditions

Adhesive Capsulitis of the Shoulder; Frozen Shoulder

Keywords

Frozen shoulder; Adhesive capsulitis; Exoskeleton robots; Robot-assisted rehabilitation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Subjective Pain Intensity: Visual Analog Scale (VAS)

  1 day

• Muscle strength of shoulder joint

  1 day

• Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)

  1 day

Study Arms (2)

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.

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.

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

Interventions

Upper limb exoskeleton-assisted therapy PROCEDURE

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.

Traditional physical therapies combine with general physical therapy

General physical therapies PROCEDURE

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 combine with general physical therapy; Upper limb exoskeleton-assisted therapy combine with general physical therapy

Traditional physical therapies PROCEDURE

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).

Upper limb exoskeleton-assisted therapy combine with general physical therapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Asia University Hospital

Taichung, Wufeng Dist., 413, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Li-Wei Chou, MD, PhD

CONTACT

+886-4-22053366; chouliwe@gmail.com

Yueh-Ling Hsieh, PT, PhD

CONTACT

+886-4-22053366; sherrie@mail.cmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): March 15, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

TW (1)