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)

Adhesive Capsulitis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02206542
• Other study ID #: 201311021DINB
• Status: Recruiting
• Phase: Phase 2
• First received: July 31, 2014
• Last updated: March 3, 2015
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: March 2015
• Source: National Taiwan University Hospital
• Contact: Jin-Shin Lai, Prof.
• Phone: 886-2-29251256
• Email: jslai[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

[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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Device:
• 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.

Other:
• Physical therapy

Device:
• Electroacupuncture

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disabilities of the Arm, Shoulder and Hand (DASH)	The DASH is a self-report questionnaire (30 items) that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb. The questionnaire can be used to assess any or all joints in the upper limb. The questionnaire records symptoms as well as activity performance. The DASH includes two optional modules relating to Work or Sports/Performing Arts. A shorter version of the DASH, the QuickDASH is available. However, the DASH provides greater precision for monitoring individual arm pain and function and hence is recommended for use in the clinical setting.	One year	Yes
Primary	Shoulder Pain And Disability Index (SPADI)	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.	One year	Yes
Primary	Passive and Active Range of Motion	The range of motion represents the distance (linear or angular)between the proximal and distal part of target joint.	One year	Yes
Primary	Musculoskeletal Ultrasound	Ultrasonic evaluation of coracohumeral ligament thickness, integrity of supraspinatus tendon and subdeltoid bursa	One year	Yes