Exergames on Shoulder Pain and Motor Function

Stroke Clinical Trial

Official title:

Effects of Exergames on Post-stroke Shoulder Pain and Motor Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03716206
• Other study ID #: 201810003B
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: National Yang Ming University
• Contact: Yang Yea-Ru, PhD
• Phone: +88628267279
• Email: yryang[@]ym.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain
• Stroke

Intervention

Device:
• Exergame
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.

Other:
• Physical therapy
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei	Beitou

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Shoulder Pain Disability Index	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.	Change from Baseline at 7 weeks
Primary	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.	Change from Baseline at 7 weeks
Primary	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).	Change from Baseline at 7 weeks
Secondary	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.	Change from Baseline at 7 weeks
Secondary	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.	Change from Baseline at 7 weeks