Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain (EHSP)
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|ClinicalTrials.gov Identifier: NCT02837068|
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Device: Wheelchair handrail compensator Device: Ordinary wheelchair||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect and Evaluation: A Randomized Controlled Trial of Wheelchair Handrail Compensator and Rehabilitation Training for Stroke Patients With Shoulder Pain|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||November 2015|
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.
Device: Wheelchair handrail compensator
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.
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.
Device: Ordinary wheelchair
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) [ 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.
- 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. ]0-10, with higher scores indicating higher degrees of pain.The VAS was commonly used in pain assessment.
- 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. ]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.
- 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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837068
|Guangdong Provincial Hospital of Chinese medicine|
|Guangzhou, Guangdong, China, 510120|
|Study Chair:||Hongxia Chen, MM||Guangdong Provincial Hospital of Traditional Chinese Medicine|