- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02837068
Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain (EHSP)
July 14, 2016 updated by: Guangzhou University of Traditional Chinese Medicine
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Guangdong Provincial Hospital of Chinese Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Wheelchair handrail compensator
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.
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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.
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Active Comparator: Ordinary wheelchair
When a patient sitting on the wheelchair, the paralysis upper limb was put on the ordinary handrail for at least 60 minutes one day.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)
Time Frame: Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.
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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.
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Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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0-10, with higher scores indicating higher degrees of pain.The VAS was commonly used in pain assessment.
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Change of shoulder pain is measured using the Visual Analogue Pain Scale (VAS) from baseline at 4 and 12 weeks.
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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.
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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.
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Change of independence is measured using the Modified Barthel Index (MBI) from baseline at 4 and 12 weeks.
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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.
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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.
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Change of quality of life is measured using the Quality of Life Index (QLI) from baseline at 4 and 12 weeks.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hongxia Chen, MM, Guangdong Provincial Hospital of Traditional Chinese Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
July 11, 2016
First Submitted That Met QC Criteria
July 14, 2016
First Posted (Estimate)
July 19, 2016
Study Record Updates
Last Update Posted (Estimate)
July 19, 2016
Last Update Submitted That Met QC Criteria
July 14, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012B091100487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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