Exergames on Shoulder Pain and Motor Function

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

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

Study Overview

• Status: Unknown
• Conditions: Stroke; Shoulder Pain
• Intervention / Treatment: Device: Exergame; Other: Physical therapy

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Yea-Ru, PhD; Phone Number: +88628267279; Email: yryang@ym.edu.tw

Study Locations

• Taiwan
  • Beitou
    • Taipei, Beitou, Taiwan, 112
      • Recruiting
      • Taipei Veterans General Hospital
      • Contact: Yea-Ru Yang; Phone Number: +886 228267279; Email: yryang@ym.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 20, 2018
• First Submitted That Met QC Criteria: October 20, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Shoulder Pain; Motor function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Stroke; Shoulder Pain
• Other Study ID Numbers: 201810003B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No