NCT01913509

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

3.6 years

First QC Date

July 30, 2013

Last Update Submit

July 31, 2018

Conditions

Stroke

Keywords

hemiplegic shoulder painpoststroke fatiguefunctional electrical stimulationstroke rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Vertical Numerical Rating Scale with Faces Rating Scale

    The NRS supplemented with the Wong-Baker FRS is a combination of the 0- to 10-point vertical NRS with word anchors and the six facial expressions of the FRS facilitating scoring the intensity of participants' pain/fatigue. The question for measuring pain/fatigue will be: "How much hemiplegic shoulder pain/poststroke fatigue do you feel today? Please point to the number that best reflects your current level of hemiplegic shoulder pain/poststroke fatigue"

    2 minutes

  • Brief Pain Inventory (BPI)

    The BPI includes four ratings of the intensity of pain (items 3-7), and seven that cover the impact of pain. Since pain can be quite variable over a day, the BPI asks patients to rate their pain at the time of responding to the questionnaire (pain now), and also at its worst, least, and average over the previous day, with 0 being "no pain" and 10 being "pain as bad as you can imagine." The pain now, worst, least, and average rating will be combined to give a composite index of pain severity. Interference of pain is to estimate the degree to which pain limits patients' functions in the past one week, with 0 being "no interference" and 10 being "interferes completely." The BPI asks for ratings of the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. The mean of these scores will be used as a pain interference score.

    3 minutes

  • Brief Fatigue Inventory (BFI)

    The BFI was developed to measure the severity of fatigue and the impact of fatigue on daily functioning in cancer populations. The BFI uses a 0-10 numeric rating scale to measure fatigue severity (worst fatigue, usual fatigue, fatigue now) and interference with life activities (general activity, mood, walking ability, normal work, relationships to others, sleep, and enjoyment of life) in the past 24 hours, with 0 (no fatigue/no interference) to 10 (fatigue as bad as you can imagine/completely interferences). A composite fatigue severity score is the average of the three severity items and a composite fatigue interference score is the average of the six interference items. A global fatigue score will be obtained by averaging all the items on the BFI.

    3 minutes

  • Fugel Meyer Assessment (FMA)

    The FMA was developed to measure the motor impairments of stroke patients.

    5 to 10 minutes

Secondary Outcomes (4)

  • Functional Independent Measure (FIM)

    3 minutes

  • Stroke Impact Scale (SIS) version 3

    5 minutes

  • Nottingham Extended Activities of Daily Living Scale (NEADL)

    3 minutes

  • 10-meter walk test

    2 minutes

Study Arms (2)

Combined Therapy of FES and BAT

EXPERIMENTAL

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.

Device: Combined Therapy of FES and BAT

Conventional Rehabilitation

ACTIVE COMPARATOR

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.

Device: Conventional Rehabilitation

Interventions

Combined Therapy of FES and BATDEVICE

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.

Combined Therapy of FES and BAT
Conventional RehabilitationDEVICE

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.

Conventional Rehabilitation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • first-ever stroke with onset duration more than 3 months;
  • self-reported at least mild intensity of hemiplegic shoulder pain and poststroke fatigue in the past 7 days (the NRS score ≥ 2);
  • Brunnstrom stage III or above and an initial Fugl-Meyer Assessment score of 56 to 79 or 65-100 indicating moderate or mild movement impairment for Stage 2;
  • no serious cognitive deficits (a score of more than 22 on the Mini Mental State Exam);
  • no participation in any experimental rehabilitation or drug studies during the study period; and (6) willing to provide written informed consent prior to study entry.

You may not qualify if:

  • history of ventricular arrhythmias, or with a cardiac pacemaker, especially those with cardiac failure with conduction problems;
  • previous contralateral stroke with persistent neurological deficit;
  • a shoulder pathology not related to the stroke (tumor, infection, scapular instability, winged scapula);
  • complicated regional pain syndrome or brachial plexus lesion;
  • diagnosis of epilepsy with history of recurring seizures in the past six months;
  • under irregular analgesia or other fatigue-relieving treatment during the study period because we expect that pain/fatigue medications might complicate measurements of shoulder pain and fatigue. If patients are on regular treatment, it has been so for more than one week;
  • acute pain after operation; and
  • auditory, visual, physical, or mental disabilities that would interfere with patients' ability to comprehend instructions for completing the outcome measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (3)

  • Lerdal A, Bakken LN, Kouwenhoven SE, Pedersen G, Kirkevold M, Finset A, Kim HS. Poststroke fatigue--a review. J Pain Symptom Manage. 2009 Dec;38(6):928-49. doi: 10.1016/j.jpainsymman.2009.04.028.

    PMID: 19811888BACKGROUND

  • Naess H, Lunde L, Brogger J. The effects of fatigue, pain, and depression on quality of life in ischemic stroke patients: the Bergen Stroke Study. Vasc Health Risk Manag. 2012;8:407-13. doi: 10.2147/VHRM.S32780. Epub 2012 Jun 27.

    PMID: 22910531BACKGROUND

  • Chuang LL, Chen YL, Chen CC, Li YC, Wong AM, Hsu AL, Chang YJ. Effect of EMG-triggered neuromuscular electrical stimulation with bilateral arm training on hemiplegic shoulder pain and arm function after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2017 Nov 28;14(1):122. doi: 10.1186/s12984-017-0332-0.

    PMID: 29183339DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Li-Ling Chuang, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 1, 2013

Study Start

December 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 1, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)