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Exergames on Shoulder Pain and Motor Function

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ClinicalTrials.gov Identifier: NCT03716206
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yea-Ru Yang, National Yang Ming University

Brief Summary:
This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke.

Condition or disease Intervention/treatment Phase
Shoulder Pain Stroke Device: Exergame Other: Physical therapy Not Applicable

Detailed Description:
Background and Purpose: Stroke is a major cerebrovascular disorder causing various symptoms in the world. A substantial portion of those surviving from stroke typically experience neurological sequelae and stroke-related complications. Post stroke shoulder pain is a sensory disturbance is one of a common complication in patients with chronic stroke and may adversely affect patients' quality of life. Nowadays, exergame has been explored as an adjunct therapy for the management of pain for a number of conditions. This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke. Method: This is a randomized controlled trail. Sixty subjects with poststroke shoulder pain will be recruited and randomized into either the exergame (experimental) group or conventional (control) group. The intervention is one hour per day, four or five days per week for three weeks. The primary outcomes are Visual Analogue Scale, and Brief Pain Inventory - Short Form. The secondary outcomes are Fugl-Meyer Assessment for Upper Limb Extremity, Wolf motor function test and Shoulder Pain and Disability Index.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Exergames on Post-stroke Shoulder Pain and Motor Function
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: exergames group
The exergames intervention is one hour per day, four or five days per week for three weeks.
Device: Exergame
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.

Active Comparator: conventional group
The conventional group intervention is one hour per day, four or five days per week for three weeks.
Other: Physical therapy
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.




Primary Outcome Measures :
  1. Brief Pain Inventory - Short Form [ Time Frame: Change from Baseline at 7 weeks ]
    To assess the severity of pain and the impact of pain on daily functions. The Brief Pain Inventory - Short Form assess severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. It is available in a short (nine items) form.

  2. Visual analogue scale [ Time Frame: Change from Baseline at 7 weeks ]
    The VAS provides a continuous scale for magnitude estimation and consists of a straight line, the ends of which are defined in terms of the extreme limits of pain experience. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best).


Secondary Outcome Measures :
  1. Wolf motor function test [ Time Frame: Change from Baseline at 7 weeks ]
    This test was designed to assess the motor ability of patients with moderate to severe upper extremity motor deficits in the laboratory and clinic. The WMFT tests a broad range of upper extremity function through two strength measurements and a series of 15 functional tasks that progress from simple movements in proximal joint areas to complex movements in distal joint areas. The final time score will be the median time required for all timed tasks executed. One hundred twenty seconds is the maximum time allowed for each task attempted.

  2. Fugl-Meyer Assessment [ Time Frame: Change from Baseline at 7 weeks ]
    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively. it is common practice to assess all domains separately. The Maximum score in upper limb is 66.


Other Outcome Measures:
  1. Shoulder Pain Disability Index [ Time Frame: Change from Baseline at 7 weeks ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Unilateral hemiplegia caused by stroke
  2. Modified Ashworth Scale ≤2。
  3. Mini-Mental State Examination ≥24。
  4. Age ≥20。
  5. Shoulder pain 。

Exclusion Criteria:

  1. Shoulder joint contructure
  2. Forzen shoulder
  3. Dizzness, lesion of auditory and vision.

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): NCT03716206


Contacts
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Contact: Yang Yea-Ru, PhD +88628267279 yryang@ym.edu.tw

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Beitou, Taiwan, 112
Contact: Yea-Ru Yang    +886 228267279    yryang@ym.edu.tw   
Sponsors and Collaborators
National Yang Ming University

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Responsible Party: Yea-Ru Yang, Professor, National Yang Ming University
ClinicalTrials.gov Identifier: NCT03716206    
Other Study ID Numbers: 201810003B
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yea-Ru Yang, National Yang Ming University:
Shoulder Pain
Stroke
Motor function
Additional relevant MeSH terms:
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Shoulder Pain
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms