Chiropractic Care Plus Physiotherapy Compared to Physiotherapy Alone in Chronic Stroke Patients
NCT ID: NCT03849794
Last Updated: 2022-07-29
Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2019-01-15
2019-06-17
Brief Summary
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Based on the promising results of this initial study now planning to perform a pragmatic pilot clinical trial that will investigate the effects of 4 weeks of chiropractic care on clinical measures associated with stroke rehabilitation and function
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Detailed Description
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This burden is even higher in developing countries. Disability-adjusted life years (DALYs), which is a measure of both years of life lost and years lived with a disability, is seven times higher in developing countries compared to high-income countries. While part of this difference is possibly due to differences in age, incidence, and mortality in developing countries; the mortality of stroke has dropped by 20% while the age-standardized incidence of stroke increased by 12% between 1990 and 2010 in low and middle-income countries. This means more people have strokes, more survive, and as a result, the burden of stroke is even greater in developing countries.
Numerous rehabilitative approaches have been shown to promote motor recovery after a stroke, but advanced strategies are constantly being developed and tested in an attempt to improve long term outcomes for stroke survivors. One possible intervention that may improve post-stroke motor recovery, but has to date not been adequately tested, is chiropractic care.
Over the past two decades, numerous research studies have shown that chiropractic care can significantly influence central neural function. Studies have shown changes in somatosensory processing, sensorimotor integration and motor control following as little as a single session of chiropractic care. Sensorimotor integration is the ability of the central nervous system (CNS) to integrate sensory information from different body parts and formulate appropriate motor outputs to muscles. Effective sensorimotor integration is essential when learning new motor skills, or recovering from an injury. Another essential component for accurate movement, learning new motor skills, and/or recovering from an injury is the accuracy of internal representations of our body map, or body schema. It is essential for our brain to be accurately aware of the location of our limbs and core body in 3D space. The spine is linked biomechanically and neurologically to the limbs and yet, it know very little about how altered sensory feedback from the spine affects limb sensorimotor integration and motor performance. However, there is emerging evidence that altered spinal sensory input can alter central neural processing, possibly by impacting the brains inner body schema. There is also emerging evidence that improving spinal function with chiropractic care can rapidly alter central neural function in a variety of ways, and that these changes outlast the altered changes of input, i.e. that they are neural plastic changes.
It has been hypothesised that the central neural plastic changes that are observed following chiropractic care may be due to improvements in spinal function associated with the correction of vertebral subluxations. Vertebral subluxations have been defined as a diminished state of being, comprising of a state of reduced coherence, altered biomechanical function, altered neurological function and altered adaptability.
If chiropractic care results in improvements in spinal function that have a central neural plastic effect, this may be important for a variety of clinical populations. Recently, groups reported an increase in lower limb muscle strength of 16% in reasonably healthy subjects following a single session of chiropractic care.Study also assessed possible neural plastic changes associated with spinal manipulation by assessing the H-reflex and V-waves. By also assessing these reflexes it helped to establish whether changes in strength following chiropractic adjustments were due to spinal or supraspinal influences. The H-reflex and V-waves are neurophysiological measures that have previously been shown to change following chiropractic care and are also important indicators of changes in central nervous system function that are important for motor recovery following a stroke. The H-reflex is largely modulated by presynaptic inhibition, and motoneuron excitability (spinal input), and the V-wave is a measure of supraspinal input, or cortical drive, to the motor neuron pool. It found changes in both the H-reflex and V-waves associated with increases in strength in our study.
Other small studies have also shown an increase in strength following a single session of chiropractic care. It also recently found a significant 8% increase in lower limb muscle strength in elite taekwondo athletes after a single session of chiropractic care. One previous controlled pilot study reported a significant increase in quadriceps muscle strength following a single chiropractic adjustment session. However group allocation was not randomised, which resulted in baseline group differences, and post-intervention between-group differences were not significant (p=0.2).It also reported a decrease in quadriceps muscle inhibition and increased quadriceps muscle activation following a chiropractic adjustment session. If these changes are lasting, and also occur in people who have suffered from a stroke, they may be important for stroke recovery.
The improvements in muscle strength and fatigue following chiropractic care observed in these studies are likely attributed to increased descending drive and/or modulation in synaptic efficacy of primary afferents or their connections at spinal cord level. This may have clinical implications for a variety of patient populations and in particular, people who have suffered from a stroke, who are likely to benefit from gains in power and strength if they occur following chiropractic care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental group
Chiropractic Care Plus Physiotherapy
Experimental Group
Chiropractic Care A chiropractor will see participants in the experimental group about 3 times per week using a pragmatic approach for 4 weeks, and each session will be approximately 15-20 minutes in duration. The spinal adjustments performed in this study will be high-velocity, low-amplitude thrusts to the spine, pelvic joints, extremities or instrument-assisted adjustments
Physiotherapy:
Physiotherapists will see participants in each group 3 times per week for four weeks. Each session will be approximately 40 minutes in duration. Physiotherapy interventions are likely to include stretches and exercises, massage and mobilization as required.
Control group
Physiotherapy
Control group
The control group will receive the same physiotherapy intervention as the experimental group at the same frequency of care. The control group will also attend three passive movement sessions with the chiropractor each week, primarily to minimise the psychological effect of the interaction with the chiropractor, but also to act as a physiological control. These passive movement sessions will be 15 minutes in duration.
Interventions
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Experimental Group
Chiropractic Care A chiropractor will see participants in the experimental group about 3 times per week using a pragmatic approach for 4 weeks, and each session will be approximately 15-20 minutes in duration. The spinal adjustments performed in this study will be high-velocity, low-amplitude thrusts to the spine, pelvic joints, extremities or instrument-assisted adjustments
Physiotherapy:
Physiotherapists will see participants in each group 3 times per week for four weeks. Each session will be approximately 40 minutes in duration. Physiotherapy interventions are likely to include stretches and exercises, massage and mobilization as required.
Control group
The control group will receive the same physiotherapy intervention as the experimental group at the same frequency of care. The control group will also attend three passive movement sessions with the chiropractor each week, primarily to minimise the psychological effect of the interaction with the chiropractor, but also to act as a physiological control. These passive movement sessions will be 15 minutes in duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* have ongoing neurological deficits
* upper and/or lower limb weakness
* with a Fugl-Meyer Assessment (FMA) motor score of less than 80 at the time of enrolment.
Exclusion Criteria
* have experienced previous significant adverse reactions to chiropractic care or any type of manual therapy
* are unable to provide informed consent to participate in the trial due to cognitive impairment.
ALL
No
Sponsors
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Riphah International University
OTHER
Responsible Party
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Principal Investigators
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Imran Amjad, PhD
Role: PRINCIPAL_INVESTIGATOR
Riphah International University
Locations
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Riphah International University
Islamabad, Federal, Pakistan
Countries
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References
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Sherzai AZ, Elkind MS. Advances in stroke prevention. Ann N Y Acad Sci. 2015 Mar;1338:1-15. doi: 10.1111/nyas.12723.
Clarke DJ, Forster A. Improving post-stroke recovery: the role of the multidisciplinary health care team. J Multidiscip Healthc. 2015 Sep 22;8:433-42. doi: 10.2147/JMDH.S68764. eCollection 2015.
Bennett DA, Krishnamurthi RV, Barker-Collo S, Forouzanfar MH, Naghavi M, Connor M, Lawes CM, Moran AE, Anderson LM, Roth GA, Mensah GA, Ezzati M, Murray CJ, Feigin VL; Global Burden of Diseases, Injuries, and Risk Factors 2010 Study Stroke Expert Group. The global burden of ischemic stroke: findings of the GBD 2010 study. Glob Heart. 2014 Mar;9(1):107-12. doi: 10.1016/j.gheart.2014.01.001.
Chen JC, Shaw FZ. Progress in sensorimotor rehabilitative physical therapy programs for stroke patients. World J Clin Cases. 2014 Aug 16;2(8):316-26. doi: 10.12998/wjcc.v2.i8.316.
Feigin VL. Stroke in developing countries: can the epidemic be stopped and outcomes improved? Lancet Neurol. 2007 Feb;6(2):94-7. doi: 10.1016/S1474-4422(07)70007-8. No abstract available.
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Veerbeek JM, Langbroek-Amersfoort AC, van Wegen EE, Meskers CG, Kwakkel G. Effects of Robot-Assisted Therapy for the Upper Limb After Stroke. Neurorehabil Neural Repair. 2017 Feb;31(2):107-121. doi: 10.1177/1545968316666957. Epub 2016 Sep 24.
Greisberger A, Aviv H, Garbade SF, Diermayr G. Clinical relevance of the effects of reach-to-grasp training using trunk restraint in individuals with hemiparesis poststroke: A systematic review. J Rehabil Med. 2016 Apr 28;48(5):405-16. doi: 10.2340/16501977-2077.
Wist S, Clivaz J, Sattelmayer M. Muscle strengthening for hemiparesis after stroke: A meta-analysis. Ann Phys Rehabil Med. 2016 Apr;59(2):114-24. doi: 10.1016/j.rehab.2016.02.001. Epub 2016 Mar 8.
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Haavik H, Murphy B. The role of spinal manipulation in addressing disordered sensorimotor integration and altered motor control. J Electromyogr Kinesiol. 2012 Oct;22(5):768-76. doi: 10.1016/j.jelekin.2012.02.012. Epub 2012 Apr 6.
Taylor HH, Murphy B. Altered central integration of dual somatosensory input after cervical spine manipulation. J Manipulative Physiol Ther. 2010 Mar-Apr;33(3):178-88. doi: 10.1016/j.jmpt.2010.01.005.
Niazi IK, Turker KS, Flavel S, Kinget M, Duehr J, Haavik H. Changes in H-reflex and V-waves following spinal manipulation. Exp Brain Res. 2015 Apr;233(4):1165-73. doi: 10.1007/s00221-014-4193-5. Epub 2015 Jan 13.
Kerzoncuf M, Bensoussan L, Delarque A, Durand J, Viton JM, Rossi-Durand C. Plastic changes in spinal synaptic transmission following botulinum toxin A in patients with post-stroke spasticity. J Rehabil Med. 2015 Nov;47(10):910-6. doi: 10.2340/16501977-2014.
Fimland MS, Moen PM, Hill T, Gjellesvik TI, Torhaug T, Helgerud J, Hoff J. Neuromuscular performance of paretic versus non-paretic plantar flexors after stroke. Eur J Appl Physiol. 2011 Dec;111(12):3041-9. doi: 10.1007/s00421-011-1934-z. Epub 2011 Apr 1.
Pandian S, Arya KN, Kumar D. Minimal clinically important difference of the lower-extremity fugl-meyer assessment in chronic-stroke. Top Stroke Rehabil. 2016 Aug;23(4):233-9. doi: 10.1179/1945511915Y.0000000003. Epub 2016 Apr 16.
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Holt K, Niazi IK, Amjad I, Kumari N, Rashid U, Duehr J, Navid MS, Shafique M, Haavik H. The Effects of 4 Weeks of Chiropractic Spinal Adjustments on Motor Function in People with Stroke: A Randomized Controlled Trial. Brain Sci. 2021 May 21;11(6):676. doi: 10.3390/brainsci11060676.
Other Identifiers
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RiphahIU Imran khan Niazi
Identifier Type: -
Identifier Source: org_study_id
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