Shoulder PainEHSPNCT02837068
Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain
A study testing Wheelchair handrail compensator and Ordinary wheelchair in people with Shoulder Pain, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine whether wheelchair handrail compensator plus rehabilitation training could do better than ordinary wheelchair plus rehabilitation training in relieving pain and improving daily life activity, upper limb motor function and quality of life for patients with hemiplegic shoulder… Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Wheelchair handrail compensator and Ordinary wheelchair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Nov 2015
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Specific diagnosis refer to the "China guideline for cerebrovascular disease prevention and treatment"
- Course of disease range from two weeks to six months
- Age range from 20 to 85 years old
- Brunnstrom scale range from I to II
- Good mental status and could be able to answer questions
Who cannot join
- Patients with brain trauma, thalamic lesions or peripheral neuropathy
- Patients with a history of cervical spondylosis, periarthritis, fracture or trauma at the shoulder, osteoporosis or myocardial infarction which could cause shoulder pain
- Patients get worse as a result of cerebral edema or coma following stroke
- Patients with serious infection or disorder in heart, liver and kidney
- Patients withdraw from the research by themselves
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Provincial Hospital of Chinese medicine
Guangzhou, Guangdong, 510120
About this study
Official title: Effect and Evaluation: A Randomized Controlled Trial of Wheelchair Handrail Compensator and Rehabilitation Training for Stroke Patients With Shoulder Pain
The purpose of this study is to determine whether wheelchair handrail compensator plus rehabilitation training could do better than ordinary wheelchair plus rehabilitation training in relieving pain and improving daily life activity, upper limb motor function and quality of life for patients with hemiplegic shoulder pain.
Read the detailed description
The ideal management of hemiplegic shoulder pain(HSP) is prevention,and a normal limb position is necessary for preventing and reducing hemiplegic shoulder pain.The foam or board supports has been used to prevent shoulder pain and could be recommended for wheelchair users to keep normal position. Therefore, the investigators designed the equipment wheelchair handrail compensator and expected to help paralyzed limbs to maintain a normal position.Using of the wheelchair handrail compensator may help patients achieve: pain relieve, improvement of upper limb function and increase of the quality of life.The aim of this study was to evaluate the effect of treatment by wheelchair handrail compensator and rehabilitation training for people with hemiplegic shoulder pain.
- Conditions
- Shoulder Pain
- Being tested
- Wheelchair handrail compensator, Ordinary wheelchair
- Keywords
- Hemiplegia, shoulder pain, wheelchair, stroke, rehabilitation
- Medical subject headings
- Shoulder Pain, Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair handrail compensatorDevice
Patients were treated by wheelchair handrail compensator for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks. The handrail compensator would help the paralysis upper limb kept the shoulder joint stretch forward, the elbow joint extend, the forearm in pronation, the wrist in flection and the fingers extend.
Ordinary wheelchairDevice
Patients were treated by ordinary wheelchair for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks.The ordinary handrail could prevent the disable arm from sinking, but could not help the upper limp keep a normal position.
| Study group | Role | What they receive |
|---|---|---|
| Wheelchair handrail compensator | Experimental | When a patient sitting on the wheelchair, the physiotherapist put the paralysis upper limb on the handrail compensator and keep the limb in normal position for at least 60 minutes one day. Receives: Device: Wheelchair handrail compensator |
| Ordinary wheelchair | Active comparator | When a patient sitting on the wheelchair, the paralysis upper limb was put on the ordinary handrail for at least 60 minutes one day. Receives: Device: Ordinary wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)
0-66, with higher scores indicating higher function of movement.UE-FM was a well-established stroke motor measure, iteratively determining active movement at each joint of the upper extremity. The UE-FM items were organized into scales that discern isolated movements at increasingly distal upper extremity regions.
Measured: Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.
Secondary outcomes (3)
Change of Visual Analogue Pain Scale (VAS)
0-10, with higher scores indicating higher degrees of pain.The VAS was commonly used in pain assessment.
Measured: Change of shoulder pain is measured using the Visual Analogue Pain Scale (VAS) from baseline at 4 and 12 weeks.
Change of Modified Barthel Index (MBI)
0-100, with higher scores indicating higher levels of independence.The Barthel Index (BI) score is a 10-item measure of activities of daily living. It has been proved that the BI has excellent inter-rater reliability for standard administration after stroke. The MBI, modified from BI by Shah, is more sensitive to small changes in functional assessment than the BI.
Measured: Change of independence is measured using the Modified Barthel Index (MBI) from baseline at 4 and 12 weeks.
Change of Quality of Life Index (QLI)
0-5, with higher scores indicating higher quality of life. The QLI is a generic measure for the evaluation of quality of life (QOL) that was initially used in patients with chronic diseases or pain. It has reported that QLI have good reliability and validity in measuring pain disorder.
Measured: Change of quality of life is measured using the Quality of Life Index (QLI) from baseline at 4 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startDec 2012
- Primary completionOct 2015
- Study completionNov 2015
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongxia Chen, MM, Study chair, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837068
- Sponsor's protocol ID
- 2012B091100487
- Acronym
- EHSP
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Evaluation: A Randomized Controlled Trial of Wheelchair Handrail Compensator and Rehabilitation Training for Stroke Patients With Shoulder Pain
- ClinicalTrials.gov ID
- NCT02837068
- Acronym / sponsor ID
- EHSP / 2012B091100487
- Conditions
- Shoulder Pain
- Keywords
- Hemiplegia, shoulder pain, wheelchair, stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 Jul 2016 (estimated)
- 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.
The purpose of this study is to determine whether wheelchair handrail compensator plus rehabilitation training could do better than ordinary wheelchair plus rehabilitation training in relieving pain and improving daily life activity, upper limb motor function and quality of life for patients with hemiplegic shoulder pain.
Detailed description
The ideal management of hemiplegic shoulder pain(HSP) is prevention,and a normal limb position is necessary for preventing and reducing hemiplegic shoulder pain.The foam or board supports has been used to prevent shoulder pain and could be recommended for wheelchair users to keep normal position. Therefore, the investigators designed the equipment wheelchair handrail compensator and expected to help paralyzed limbs to maintain a normal position.Using of the wheelchair handrail compensator may help patients achieve: pain relieve, improvement of upper limb function and increase of the quality of life.The aim of this study was to evaluate the effect of treatment by wheelchair handrail compensator and rehabilitation training for people with hemiplegic shoulder pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheelchair handrail compensator | Experimental | Device: Wheelchair handrail compensatorWhen a patient sitting on the wheelchair, the physiotherapist put the paralysis upper limb on the handrail compensator and keep the limb in normal position for at least 60 minutes one day. |
| Ordinary wheelchair | Active comparator | Device: Ordinary wheelchairWhen a patient sitting on the wheelchair, the paralysis upper limb was put on the ordinary handrail for at least 60 minutes one day. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Specific diagnosis refer to the "China guideline for cerebrovascular disease prevention and treatment"
- Course of disease range from two weeks to six months
- Age range from 20 to 85 years old
- Brunnstrom scale range from I to II
- Good mental status and could be able to answer questions
Key exclusion criteria (5 listed)
- Patients with brain trauma, thalamic lesions or peripheral neuropathy
- Patients with a history of cervical spondylosis, periarthritis, fracture or trauma at the shoulder, osteoporosis or myocardial infarction which could cause shoulder pain
- Patients get worse as a result of cerebral edema or coma following stroke
- Patients with serious infection or disorder in heart, liver and kidney
- Patients withdraw from the research by themselves
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 |
|---|---|---|
| Wheelchair handrail compensatorPatients were treated by wheelchair handrail compensator for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks. The handrail compensator would help the paralysis upper limb kept the shoulder joint stretch forward, the elbow joint extend, the forearm in pronation, the wrist in flection and the fingers extend. | Device | Wheelchair handrail compensator |
| Ordinary wheelchairPatients were treated by ordinary wheelchair for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks.The ordinary handrail could prevent the disable arm from sinking, but could not help the upper limp keep a normal position. | Device | Ordinary wheelchair |
Primary outcome
Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)
Time frame: Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.
0-66, with higher scores indicating higher function of movement.UE-FM was a well-established stroke motor measure, iteratively determining active movement at each joint of the upper extremity. The UE-FM items were organized into scales that discern isolated movements at increasingly distal upper extremity regions.
3 secondary outcomes
Change of Visual Analogue Pain Scale (VAS)
Time frame: Change of shoulder pain is measured using the Visual Analogue Pain Scale (VAS) from baseline at 4 and 12 weeks.
Change of Modified Barthel Index (MBI)
Time frame: Change of independence is measured using the Modified Barthel Index (MBI) from baseline at 4 and 12 weeks.
Change of Quality of Life Index (QLI)
Time frame: Change of quality of life is measured using the Quality of Life Index (QLI) from baseline at 4 and 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Hongxia Chen, MM study chair
Guangdong Provincial Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair handrail compensator and Ordinary wheelchair in people with Shoulder Pain, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
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 5 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: finished, as of the sponsor's last update on 19 Jul 2016. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM) (time frame: Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.). 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 19 Jul 2016.