Exergames on Shoulder Pain and Motor Function
Primary Purpose
Shoulder Pain, Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Exergame
Physical therapy
Sponsored by

About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder Pain, Stroke, Motor function
Eligibility Criteria
Inclusion Criteria:
- Unilateral hemiplegia caused by stroke
- Modified Ashworth Scale ≤2。
- Mini-Mental State Examination ≥24。
- Age ≥20。
- Shoulder pain 。
Exclusion Criteria:
- Shoulder joint contructure
- Forzen shoulder
- Dizzness, lesion of auditory and vision.
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
exergames group
conventional group
Arm Description
The exergames intervention is one hour per day, four or five days per week for three weeks.
The conventional group intervention is one hour per day, four or five days per week for three weeks.
Outcomes
Primary Outcome Measures
Brief Pain Inventory - Short Form
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.
Visual analogue scale
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
Wolf motor function test
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.
Fugl-Meyer Assessment
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.
Full Information
NCT ID
NCT03716206
First Posted
October 20, 2018
Last Updated
March 28, 2019
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT03716206
Brief Title
Exergames on Shoulder Pain and Motor Function
Official Title
Effects of Exergames on Post-stroke Shoulder Pain and Motor Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Stroke
Keywords
Shoulder Pain, Stroke, Motor function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exergames group
Arm Type
Experimental
Arm Description
The exergames intervention is one hour per day, four or five days per week for three weeks.
Arm Title
conventional group
Arm Type
Active Comparator
Arm Description
The conventional group intervention is one hour per day, four or five days per week for three weeks.
Intervention Type
Device
Intervention Name(s)
Exergame
Intervention Description
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.
Primary Outcome Measure Information:
Title
Brief Pain Inventory - Short Form
Description
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.
Time Frame
Change from Baseline at 7 weeks
Title
Visual analogue scale
Description
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).
Time Frame
Change from Baseline at 7 weeks
Secondary Outcome Measure Information:
Title
Wolf motor function test
Description
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.
Time Frame
Change from Baseline at 7 weeks
Title
Fugl-Meyer Assessment
Description
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.
Time Frame
Change from Baseline at 7 weeks
Other Pre-specified Outcome Measures:
Title
Shoulder Pain Disability Index
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.
Time Frame
Change from Baseline at 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral hemiplegia caused by stroke
Modified Ashworth Scale ≤2。
Mini-Mental State Examination ≥24。
Age ≥20。
Shoulder pain 。
Exclusion Criteria:
Shoulder joint contructure
Forzen shoulder
Dizzness, lesion of auditory and vision.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Yea-Ru, PhD
Phone
+88628267279
Email
yryang@ym.edu.tw
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
State/Province
Beitou
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ru Yang
Phone
+886 228267279
Email
yryang@ym.edu.tw
12. IPD Sharing Statement
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Exergames on Shoulder Pain and Motor Function
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