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Trial record 24 of 52 for:    "Frozen Shoulder"

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)

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ClinicalTrials.gov Identifier: NCT02206542
Recruitment Status : Unknown
Verified March 2015 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : August 1, 2014
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Device: Upper limb rehabilitation robot Other: Physical therapy Device: Electroacupuncture Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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 Start Date : June 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robot-assisted group
Electroacupuncture, physical therapy and upper limb rehabilitation robot
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
Active Comparator: Control group
Electroacupuncture and physical therapy
Other: Physical therapy
Device: Electroacupuncture



Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand (DASH) [ Time Frame: One year ]
    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.

  2. Shoulder Pain And Disability Index (SPADI) [ Time Frame: One year ]
    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.

  3. Passive and Active Range of Motion [ Time Frame: One year ]
    The range of motion represents the distance (linear or angular)between the proximal and distal part of target joint.

  4. Musculoskeletal Ultrasound [ Time Frame: One year ]
    Ultrasonic evaluation of coracohumeral ligament thickness, integrity of supraspinatus tendon and subdeltoid bursa



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02206542


Contacts
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Contact: Jin-Shin Lai, Prof. 886-2-29251256 jslai@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shin Lai, Prof.    886-2-29251256    jslai@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: Jin-Shin Lai, Prof. Health Science and Wellness Center/Dept. of Physical Medicine & Rehabilitation

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02206542     History of Changes
Other Study ID Numbers: 201311021DINB
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: March 2015
Keywords provided by National Taiwan University Hospital:
acupuncture,frozen shoulder,robot,sonography,MRI
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases