A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

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.

Conditions

Interventions

  • Conventional rehabilitation Procedure
    Intervention Desc: Stroke patients in CR group receive the protocol which includes (1) TENS; (2) BAT. The activities are adapted based on the level of motor impairment, and functional needs of individual patients.
    ARM 1: Kind: Experimental
    Label: Conventional Rehabilitation
    Description: The stroke patients in CR group receive a structure protocol using electrical modality such as transcutaneous electrical nerve stimulation (TENS) and bilateral arm training (TENS-BAT) one hour daily, 3 days per week for 4 weeks and a total of 12 sessions.
  • Combined Therapy of FES and GTT Device
    Intervention Desc: FES treatment will be applied to stimulate the supraspinatus muscle with an active electrode over the posterior deltoid muscle avoid shaking of the shoulder. At the same time, patients will walk on the treadmill while supported in a harness with a comfortable speed, using gradually increasing inclination angles and by increasing the total walking time. At the start of the training, patients walk twice for 10 minutes at 40% maximum heart rate (maxHR) and the HR is kept constant for one week, during which the walking duration increases to twice 20 minutes. In week 2, the training heart rate is set at 50% maxHR with gradually increasing durations, which is gradually increased every week to 70% maxHR at the end of 4-week intervention.
    ARM 1: Kind: Experimental
    Label: Combined Therapy of FES and GTT
    Description: Patients with ambulatory ability will be applied functional electrical stimulation and walking on a treadmill one hour daily, 3 days per week for 4 weeks and a total of 12 sessions to stimulate the supraspinatus muscle with an active electrode over the posterior deltoid muscle avoid shaking of the shoulder.
  • Conventional Rehabilitation 1 Device
    Intervention Desc: Ambulatory patients in CR group will receive the protocol which includes (1) TENS; (2) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes; (3) gross motor training for 20 minutes; (4) muscle strengthening of the affected limb for 15 to 20 minutes; and (5) assisted overground walking with aids such as ankle-foot orthoses for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment, walking capacity, and functional needs of individual patients.
    ARM 1: Kind: Experimental
    Label: Conventional Rehabilitation 1
    Description: The ambulatory stroke patients in CR group will receive a structure protocol using electrical modality such as TENS and conventional physical therapy techniques such as neurodevelopmental techniques with emphasis on functional tasks and muscle strengthening.
  • Combined Therapy of FES and BWSTT Device
    Intervention Desc: The intervention group at Stage 3 will walk on a treadmill while body weight supported (BWSTT) in a harness, which offers the safety and mobility. Initial body weight support will be set so that the knee is within 15 degrees of extension. Initial speed of the treadmill will be set so that the therapist has time to assist the leg to swing through while maintaining a reasonable step length. The amount of body weight support will be reduced once participants can (1) swing their affected leg through without help, (2) maintain a straight knee during stance phase without hyperextension, and (3) maintain an adequate step length without help.
    ARM 1: Kind: Experimental
    Label: Combined Therapy of FES and BWSTT
    Description: Patients with non-ambulatory ability will receive combined Therapy of Functional electrical stimulation and Body Weight Supported Treadmill Training (FES-BWSTT).
  • Conventional Rehabilitation 2 Device
    Intervention Desc: The non-ambulatory patients in CR group will receive a structure protocol using electrical modality such as TENS and conventional physical therapy techniques such as neurodevelopmental techniques with emphasis on functional tasks and muscle strengthening. The protocol will include (1) TENS; (2) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes; (3) gross motor training for 20 minutes; (4) muscle strengthening of the affected limb for 15 to 20 minutes; and (5) assisted overground walking with aids such as ankle-foot orthoses for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment, walking capacity, and functional needs of individual patients.
    ARM 1: Kind: Experimental
    Label: Conventional Rehabilitation 2
    Description: The non-ambulatory patients in CR group is designed to control for the duration of patient-therapist interactions and therapeutic activities (1 hours/day, 3 days/week, for 4 weeks).
  • Combined Therapy of FES and BAT Device
    Intervention Desc: FES treatment is applied to stimulate the supraspinatus muscle and the posterior deltoid muscle of the affected shoulder. Then patients receive bilateral arm training focused on reaching, shoulder abduction, and shoulder horizontal abduction.
    ARM 1: Kind: Experimental
    Label: Combined Therapy of FES and BAT
    Description: Patients with hemiplegic shoulder pain is applied functional electrical stimulation and bilateral arm training (FES-BAT) one hour daily, 3 days per week for 4 weeks and a total of 12 sessions to stimulate the supraspinatus muscle and the posterior deltoid muscle of the affected arm.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Vertical Numerical Rating Scale with Face Rating Scale 3 minutes No
Secondary Brief Pain Inventory (BPI) 5 to 10 minutes No
Secondary Brief Fatigue Inventory (BFI) 5 to 10 minuttes No
Primary Vertical Numerical Rating Scale with Faces Rating Scale 2 minutes No
Primary Fugel Meyer Assessment (FMA) 5 to 10 minutes No
Secondary Functional Independent Measure (FIM) 3 minutes No
Secondary Stroke Impact Scale (SIS) version 3 5 minutes No
Secondary Nottingham Extended Activities of Daily Living Scale (NEADL) 3 minutes No
Secondary 10-meter walk test 2 minutes No

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