Clinical trial NCT02837068: Effect of Wheelchair Handrail Compensator and Rehabilitation Training for Patients With Hemiplegic Shoulder Pain
Official title: Effect and Evaluation: A Randomized Controlled Trial of Wheelchair Handrail Compensator and Rehabilitation Training for Stroke Patients With Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Hemiplegia
shoulder pain
wheelchair
stroke
rehabilitation
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Upper extremity Fugl-Meyer Assessment scale (UE-FM)
timeFrame: Change from baseline Upper Extremity Fugl-Meyer Assessment scale at 12 weeks.
Secondary outcomes:
measure: Change of Visual Analogue Pain Scale (VAS)
timeFrame: Change of shoulder pain is measured using the Visual Analogue Pain Scale (VAS) from baseline at 4 and 12 weeks.
measure: Change of Modified Barthel Index (MBI)
timeFrame: Change of independence is measured using the Modified Barthel Index (MBI) from baseline at 4 and 12 weeks.
measure: Change of Quality of Life Index (QLI)
timeFrame: Change of quality of life is measured using the Quality of Life Index (QLI) from baseline at 4 and 12 weeks.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Hongxia Chen, MM
role: STUDY_CHAIR
References: