Stroke Clinical Trial
Official title:
A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect
The investigators anticipate this research will shed light on metric properties of outcome measures of pain and fatigue and the effects of the combined therapy for stroke patients. The overall findings will contribute to guide the choice of proper assessment tool and the development of effective rehabilitation programs.
Hemiplegic shoulder pain affects from 16%-84% of stroke patients and fatigue occurs among
39%-72% of stroke victims, which can have an adverse impact on rehabilitation outcomes by
interrupting treatment process, daily functions, and quality of life (QOL) for stroke
patients. Considering the high prevalence and detrimental effects of poststroke shoulder pain
and fatigue, it is vital for monitoring these symptoms and therapeutic interventions to be
developed for those suffering from poststroke pain and fatigue. Therefore, to validate
existing assessments of pain/fatigue, and to evaluate the efficacy of potential pain/fatigue
interventions are needed.
A vertical Numerical Rating Scale with Faces Rating Scale (NRS-FRS) could be used by all
stroke patients as pain and fatigue measurement. The Brief Pain Inventory (BPI) and Brief
Fatigue Inventory (BFI) measure pain/fatigue intensity and pain/fatigue interference, which
might provide more information regarding pain/fatigue symptoms. The first aim of this
research is to examine the psychometric properties of the vertical NRS-FRS, BPI, and BFI.
Functional electrical stimulation (FES) appears to offer benefits in relieving painful
hemiplegic shoulder. Previous studies have shown that therapeutic electrical stimulation of
the posterior deltoid and supraspinatus muscles significantly reduces shoulder subluxation,
but inconsistent results on pain reduction, pain-free range of motion of the affected
shoulder joint, and arm function. Conventional rehabilitation usually applies transcutaneous
electrical nerve stimulation (TENS) to relieve pain. Bilateral arm training (BAT) is one of
the novel interventions in stroke rehabilitation to improve motor recovery of the affected
arm, especially proximal part of the upper-limb.Therefore, the second aim of this research is
to investigate whether the combined therapy of FES and BAT (FES-BAT) could reduce hemiplegic
shoulder pain and improve motor function of the affected arm as compared with TENS plus BAT
(TENS-BAT). Whether interventions could further lead to better functional performance and
higher QOL would be of interest.
This 3-year project is implemented in three stages and recruit 80 patients with chronic
stroke. At the first stage, investigators conduct a test-retest study to investigate the
reliability and validity of outcome measures on hemiplegic shoulder pain and poststroke
fatigue in 80 patients. At the second stage, investigators conduct a randomized controlled
trial (RCT) to investigate the relative effects of the FES-BAT versus TENS-BAT for 40 stroke
patients with hemiplegic shoulder pain and moderate-to-mild motor impairment. Treatment
regimens are designed to ensure that patients in the 2 groups receive an equivalent intensity
of treatment (1 hour/day, 3 days/week for 4 weeks). At the third stage, investigators will
determine clinimetric properties of the primary outcome measures, such as responnsiveness,
minimal detectable change, and minimal clinical important change.
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