Stroke Clinical Trial
Official title:
A Study of Post-Stroke Pain and Fatigue: Clinical Evaluation and Treatment Effect
Verified date | July 2018 |
Source | Chang Gung University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. first-ever stroke with onset duration more than 3 months; 2. self-reported at least mild intensity of hemiplegic shoulder pain and poststroke fatigue in the past 7 days (the NRS score = 2); 3. 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; 4. no serious cognitive deficits (a score of more than 22 on the Mini Mental State Exam); 5. 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. Exclusion Criteria: 1. history of ventricular arrhythmias, or with a cardiac pacemaker, especially those with cardiac failure with conduction problems; 2. previous contralateral stroke with persistent neurological deficit; 3. a shoulder pathology not related to the stroke (tumor, infection, scapular instability, winged scapula); 4. complicated regional pain syndrome or brachial plexus lesion; 5. diagnosis of epilepsy with history of recurring seizures in the past six months; 6. 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; 7. acute pain after operation; and 8. auditory, visual, physical, or mental disabilities that would interfere with patients' ability to comprehend instructions for completing the outcome measures. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung University | Chang Gung Memorial Hospital, Mackay Memorial Hospital |
Taiwan,
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Fugel Meyer Assessment (FMA) | The FMA was developed to measure the motor impairments of stroke patients. | 5 to 10 minutes | |
Secondary | Functional Independent Measure (FIM) | The FIM is used to measure daily functions of stroke patients. | 3 minutes | |
Secondary | Stroke Impact Scale (SIS) version 3 | The SIS is used to assess quality of life in stroke patients. | 5 minutes | |
Secondary | Nottingham Extended Activities of Daily Living Scale (NEADL) | The NEADL is used to assess instrumental ADL ability of stroke patients. | 3 minutes | |
Secondary | 10-meter walk test | The 10-meter walk test is used to measure preferred gait speed and fasted gait speed. | 2 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|