Scientifically Merged Acupuncture and Robot-assisted Technology (SMART) for Rehabilitation of Frozen Shoulder Syndrome: Second-year Project-Comparison of Robot and Conventional Physiotherapy (Including Preliminary Test on Healthy Volunteers)

NCT ID: NCT02206542

Last Updated: 2015-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-06-30

Brief Summary

Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and disability. These patients need early and regular rehabilitation to regain their function and prevent unnecessary complications such as contracture and disuse atrophy. Proper rehabilitation is important but the challenge is also great. However, rehabilitation training is a very labor-intensive task in which one to one treatment is essential and that will restrict the number of patients served. Moreover, patients receiving home programs are difficult to supervise, resulting in reduced training effect and delayed functional recovery. In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of upper-limb exoskeleton rehabilitation robot and its related technology and human-robot interaction. This robot is used to serve the rehabilitation need of those patients suffering from upper extremities dysfunctions and also can provide careful designed therapeutic program of upper limbs including shoulder and elbow joint exercises. Its control software also provides a therapeutic management system with intelligence and ergonomic consideration. This work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and finally approved by Department of Health (DOH) in April 2011. This team had completed the clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.

Conditions

Adhesive Capsulitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Robot-assisted group

Electroacupuncture, physical therapy and upper limb rehabilitation robot

Group Type: EXPERIMENTAL

Upper limb rehabilitation robot

Intervention Type: DEVICE

Upper limb rehabilitation robot is to carry out passive shoulder joint movements including shoulder flexion, shoulder abduction, shoulder horizontal-abduction and shoulder rotation.

Physical therapy

Intervention Type: OTHER

Electroacupuncture

Intervention Type: DEVICE

Control group

Electroacupuncture and physical therapy

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

Electroacupuncture

Intervention Type: DEVICE

Interventions

Upper limb rehabilitation robot

Upper limb rehabilitation robot is to carry out passive shoulder joint movements including shoulder flexion, shoulder abduction, shoulder horizontal-abduction and shoulder rotation.

Intervention Type: DEVICE

Physical therapy

Intervention Type: OTHER

Electroacupuncture

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age from 20 to 65 years old

2. Good physical condition

1. Age from 20 to 65 years old

2. Diagnosis as adhesive capsulitis

Exclusion Criteria

1. Unconsciousness

2. History of stroke

3. Medical disease (Heart disease, cancer)

4. Shoulder lesions

5. Severe osteoporosis

6. Arrhythmia and with pacemaker device

[Subjects]

1. History of humeral fracture or trauma event around shoulder girdle

2. Central nervous system disease

3. Shockwave or injection therapy at shoulder joint in past 6 months

4. History or planning for operation at shoulder girdle

Subject within our criteria will receive both examination with ultrasound and treatment, however, there is some limitations for subjects who will be approved examination at shoulder girdle with magnetic resonance imaging:

1. Claustrophobia

2. Metal implant (Pacemaker, artificial valve prosthesis, implantable cardioverter defibrillator, nerve stimulator, in vivo drugs delivery system, intraocular implant, cochlear implants, Swan-Ganz catheter, arterial clips, bullets or metal fragments)

3. Renal insufficiency (Estimated creatinine clearance < 90 mL/min)

4. Pregnancy and breast milk feeding

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin-Shin Lai, Prof.

Role: STUDY_CHAIR

Health Science and Wellness Center/Dept. of Physical Medicine & Rehabilitation

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jin-Shin Lai, Prof.

Role: CONTACT

jslai@ntu.edu.tw

886-2-29251256

Facility Contacts

Jin-Shin Lai, Prof.

Role: primary

jslai@ntu.edu.tw

886-2-29251256

Other Identifiers

201311021DINB

Identifier Type: -

Identifier Source: org_study_id