Clinical trial NCT02206542: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adhesive Capsulitis
Keywords: acupuncture,frozen shoulder,robot,sonography,MRI
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: \[Healthy Volunteers\]

Inclusion Criteria:

1. Age from 20 to 65 years old
2. Good physical condition

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

\[Subjects\]

Inclusion Criteria:

1. Age from 20 to 65 years old
2. Diagnosis as adhesive capsulitis

Exclusion Criteria:

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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: One year
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: One year
measure: Passive and Active Range of Motion
timeFrame: One year
measure: Musculoskeletal Ultrasound
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Health Science and Wellness Center/Dept. of Physical Medicine & Rehabilitation
name: Jin-Shin Lai, Prof.
role: STUDY_CHAIR
References: