Exergames on Shoulder Pain and Motor Function

NCT03716206 | Unknown

• 1 other identifier: 201810003B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shoulder Pain; Stroke

Keywords

Shoulder Pain; Stroke; Motor function

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Wolf motor function test

  Change from Baseline at 7 weeks

• Fugl-Meyer Assessment

  Change from Baseline at 7 weeks

Other Outcomes (1)

• Shoulder Pain Disability Index

  Change from Baseline at 7 weeks

Study Arms (2)

exergames group

EXPERIMENTAL

The exergames intervention is one hour per day, four or five days per week for three weeks.

Device: Exergame

conventional group

ACTIVE COMPARATOR

The conventional group intervention is one hour per day, four or five days per week for three weeks.

Other: Physical therapy

Interventions

Exergame DEVICE

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

exergames group

Physical therapy OTHER

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

conventional group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral hemiplegia caused by stroke
• Modified Ashworth Scale ≤2。
• Mini-Mental State Examination ≥24。
• Age ≥20。
• Shoulder pain 。

You may not qualify if:

• Shoulder joint contructure
• Forzen shoulder
• Dizzness, lesion of auditory and vision.

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Yang Yea-Ru, PhD

CONTACT

+88628267279; yryang@ym.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: October 23, 2018
• Study Start: November 21, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 31, 2019
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

TW (1)