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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)

Primary Purpose

Adhesive Capsulitis

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Upper limb rehabilitation robot
Physical therapy
Electroacupuncture
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Adhesive Capsulitis focused on measuring acupuncture,frozen shoulder,robot,sonography,MRI

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

[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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot-assisted group

Control group

Arm Description

Electroacupuncture, physical therapy and upper limb rehabilitation robot

Electroacupuncture and physical therapy

Outcomes

Primary Outcome Measures

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.
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.
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.
Musculoskeletal Ultrasound
Ultrasonic evaluation of coracohumeral ligament thickness, integrity of supraspinatus tendon and subdeltoid bursa

Secondary Outcome Measures

Full Information

First Posted
July 31, 2014
Last Updated
March 3, 2015
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02206542
Brief 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)
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
Keywords
acupuncture,frozen shoulder,robot,sonography,MRI

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot-assisted group
Arm Type
Experimental
Arm Description
Electroacupuncture, physical therapy and upper limb rehabilitation robot
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Electroacupuncture and physical therapy
Intervention Type
Device
Intervention Name(s)
Upper limb rehabilitation robot
Intervention Description
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
Other
Intervention Name(s)
Physical therapy
Intervention Type
Device
Intervention Name(s)
Electroacupuncture
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand (DASH)
Description
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.
Time Frame
One year
Title
Shoulder Pain And Disability Index (SPADI)
Description
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.
Time Frame
One year
Title
Passive and Active Range of Motion
Description
The range of motion represents the distance (linear or angular)between the proximal and distal part of target joint.
Time Frame
One year
Title
Musculoskeletal Ultrasound
Description
Ultrasonic evaluation of coracohumeral ligament thickness, integrity of supraspinatus tendon and subdeltoid bursa
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
[Healthy Volunteers] Inclusion Criteria: Age from 20 to 65 years old Good physical condition Exclusion Criteria: Unconsciousness History of stroke Medical disease (Heart disease, cancer) Shoulder lesions Severe osteoporosis Arrhythmia and with pacemaker device [Subjects] Inclusion Criteria: Age from 20 to 65 years old Diagnosis as adhesive capsulitis Exclusion Criteria: History of humeral fracture or trauma event around shoulder girdle Central nervous system disease Shockwave or injection therapy at shoulder joint in past 6 months 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: Claustrophobia 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) Renal insufficiency (Estimated creatinine clearance < 90 mL/min) Pregnancy and breast milk feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Shin Lai, Prof.
Phone
886-2-29251256
Email
jslai@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Shin Lai, Prof.
Organizational Affiliation
Health Science and Wellness Center/Dept. of Physical Medicine & Rehabilitation
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Shin Lai, Prof.
Phone
886-2-29251256
Email
jslai@ntu.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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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