Clinical Trial: Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect and Evaluation: A Randomized Controlled Trial of Wheelchair Handrail Compensator and Rehabilitation Training for Stroke Patients With Shoulder Pain

Brief 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 pain.

Detailed Summary: 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.
Sponsor: Guangzhou University of Traditional Chinese Medicine

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Guangzhou University of Traditional Chinese Medicine

Dates:
Date Received: July 11, 2016
Date Started: December 2012
Date Completion:
Last Updated: July 14, 2016
Last Verified: July 2016