Exergames on Shoulder Pain and Motor Function

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

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.

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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

More Information

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

• 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:

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