An interventional study of Wheelchair handrail compensator and Ordinary wheelchair in Shoulder Pain, sponsored by Guangzhou University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-07-19.
Sponsored by Guangzhou University of Traditional Chinese Medicine · Not applicable, Interventional, and Prevention
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.
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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.
Device: Wheelchair handrail compensator
When a patient sitting on the wheelchair, the paralysis upper limb was put on the ordinary handrail for at least 60 minutes one day.
Device: Ordinary wheelchair
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.
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.
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.
Time frame: Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.
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.
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)
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.
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)
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.
Time frame: Change of quality of life is measured using the Quality of Life Index (QLI) from baseline at 4 and 12 weeks.
Plan to share: No
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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Guangzhou University of Traditional Chinese Medicine