Shoulder PainNCT03716206
Exergames on Shoulder Pain and Motor Function
A study testing Exergame and Physical therapy in people with Shoulder Pain and Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study is to investigate the effects of exergame on shoulder pain and motor function of upper extremity in individuals with stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Shoulder Pain, Stroke
- What is being tested?
- Exergame and Physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Nov 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral hemiplegia caused by stroke
- Modified Ashworth Scale ≤2。
- Mini-Mental State Examination ≥24。
- Age ≥20。
- Shoulder pain 。
Who cannot join
- Shoulder joint contructure
- Forzen shoulder
- Dizzness, lesion of auditory and vision.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, Beitou, 112
Yea-Ru Yang, +886 228267279, yryang@ym.edu.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Shoulder Pain, Stroke
- Being tested
- Exergame, Physical therapy
- Keywords
- Shoulder Pain, Stroke, Motor function
- Medical subject headings
- Shoulder Pain, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExergameDevice
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.
Physical therapyOther
This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.
| Study group | Role | What they receive |
|---|---|---|
| exergames group | Experimental | The exergames intervention is one hour per day, four or five days per week for three weeks. Receives: Device: Exergame |
| conventional group | Active comparator | The conventional group intervention is one hour per day, four or five days per week for three weeks. Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Change from Baseline at 7 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from Baseline at 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start21 Nov 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716206
- Sponsor's protocol ID
- 201810003B
- Status last verified
- Mar 2019
- First submitted
- 20 Oct 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exergames on Post-stroke Shoulder Pain and Motor Function
- ClinicalTrials.gov ID
- NCT03716206
- Acronym / sponsor ID
- 201810003B
- Conditions
- Shoulder Pain, Stroke
- Keywords
- Shoulder Pain, Stroke, Motor function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exergames group | Experimental | Device: ExergameThe exergames intervention is one hour per day, four or five days per week for three weeks. |
| conventional group | Active comparator | Other: Physical therapyThe conventional group intervention is one hour per day, four or five days per week for three weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral hemiplegia caused by stroke
- Modified Ashworth Scale ≤2。
- Mini-Mental State Examination ≥24。
- Age ≥20。
- Shoulder pain 。
Key exclusion criteria (3 listed)
- Shoulder joint contructure
- Forzen shoulder
- Dizzness, lesion of auditory and vision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExergameThis intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training. | Device | exergames group |
| Physical therapyThis intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training. | Other | conventional group |
Primary outcome
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.
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).
2 secondary outcomes
Wolf motor function test
Time frame: Change from Baseline at 7 weeks
Fugl-Meyer Assessment
Time frame: Change from Baseline at 7 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame and Physical therapy in people with Shoulder Pain and Stroke, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Yea-Ru, PhD (+88628267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory - Short Form (time frame: Change from Baseline at 7 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.