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Chiropractic Care Plus Physiotherapy Compared to Physiotherapy Alone in Chronic Stroke Patients

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ClinicalTrials.gov Identifier: NCT03849794
Recruitment Status : Completed
First Posted : February 21, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Imran Amjad, Riphah International University

Brief Summary:

The Investigator recently conducted a study in patients who had suffered from a stroke where it investigated whether similar findings are observed following a single session of chiropractic care.36 The key findings from this study was that in a group of chronic stroke patients, with lower limb muscle weakness, plantar flexion muscle strength increased on average by 64.6% following a chiropractic care session and the change in muscle strength appears to be modulated by cortical factors as opposed to modulation at the spinal level.

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


Condition or disease Intervention/treatment Phase
Chronic Stroke Other: Experimental Group Other: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and the outcome assessors ( Physiotherapists), and data analysts will remain blinded to group allocation throughout the study period.
Primary Purpose: Treatment
Official Title: The Effects of 4 Weeks of Chiropractic Care Plus Physiotherapy Compared to Physiotherapy Alone on Functional Outcomes in Chronic Stroke Patients: a Clinical Trial
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arm Intervention/treatment
Experimental: Experimental group
Chiropractic Care Plus Physiotherapy
Other: 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.

Other Name: Chiropractic Care Plus Physiotherapy

Active Comparator: Control group
Physiotherapy
Other: 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 Name: Physiotherapy+sham Chiropractic




Primary Outcome Measures :
  1. Fugl-Meyer Assessment (FMA) [ Time Frame: baseline,4th week, 8th week ]
    Changes from the Baseline, The Fugl-Meyer Assessment (FMA) (combined upper and lower limb )is a stroke-specific, performance-based impairment index. It is designed to assess motor function, balance, sensation and joint function in patients with post-stroke hemiplegia. It is applied clinically and in research to determine stroke severity, describe motor recovery, and to plan and assess treatment. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. Only the Motor Part: Motor score: ranges from 0 (hemiplegia) to 100 points (normal motor performance).Classifications for impairment severity have been proposed based on FMA Total motor scores (out of 100 points) [< 50 = Severe, 50-84 = Marked, 85-94 = Moderate and 95-99 = Slight ]


Secondary Outcome Measures :
  1. Stroke Specific Quality of Life Scale [ Time Frame: baseline,4th week, 8th week ]
    Changes from the Baseline, The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Scoring: each item shall be scored with the following key Total help - Couldn't do it at all - Strongly agree (1), A lot of help - A lot of trouble - Moderately agree (2), Some help - Some trouble - Neither agree nor disagree (3), A little help - A little trouble - Moderately disagree (4) No help needed - No trouble at all - Strongly disagree (5)

  2. Modified Rankin Scale (mRS) [ Time Frame: baseline,4th week, 8th week ]
    Changes from the Baseline, The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead.

  3. Timed up and Go Test (TUG) [ Time Frame: baseline,4th week, 8th week ]
    Changes from the Baseline, The TUG is a widely used test of basic functional mobility that is sensitive to change and is suitable for the assessment of stroke patients.The TUG involves participants standing from a seated position, walking 3 meters, turning around and returning to sit in the chair. The time to complete this task is recorded using a stopwatch.

  4. Heart Rate Variability(HRV) [ Time Frame: baseline,4th week, 8th week ]
    HRV will be used as a objective assessment of psychological health and stress for the patients.

  5. Daily Movement [ Time Frame: 1 Week ]
    Accelerometer sensor will be used for a subset of patients to monitor the amount of daily movement during a week chosen randomly out of 4 weeks of care.

  6. Blood Marker (Brain-derived neurotrophic factor, BDNF) [ Time Frame: baseline,4th week, 8th week ]
    BDNF, is a protein that, in humans, is encoded by the BDNF Gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the canonical nerve growth factor. Neurotrophic factors are found in the brain and the periphery. Changes from the baseline; BDNF levels were evaluated using immunoenzymatic method (ELISA) in plasma samples taken in each patient.

  7. Blood marker (Glial cell-derived neurotrophic factor, GDNF) [ Time Frame: baseline,4th week, 8th week ]
    Glial cell-derived neurotrophic factor (GDNF) is a protein that, in humans, is encoded by the GDNF gene. GDNF is a small protein that potently promotes the survival of many types of neurons. Changes from the baseline; GDNF levels were evaluated using immunoenzymatic method (ELISA) in plasma samples taken in each patient.

  8. Blood Marker (Insulin-like growth factor 2, IGF2) [ Time Frame: baseline,4th week, 8th week ]
    Insulin-like growth factor 2 is one of three protein hormones that share structural similarity to insulin. Changes from the baseline; IGF2 levels were evaluated using immunoenzymatic method (ELISA) in plasma samples taken in each patient.


Other Outcome Measures:
  1. Transcranial Magnetic Stimulation (change in level of cortico-spinal cord excitability) [ Time Frame: 1 Week ]

    TMS will be used in pre and post intervention in first session only for those patients for whom motor evoked response can be evoked at resting state.

    A TMS assessment involves applying consistent magnetic stimuli to the brain and recording EMG activity from the targeted muscle. The level of activity in the muscle will change based on the level of excitability in the nervous system. It will assess whether the level of excitability changes pre and post the different interventions that we will be applying based on the EMG recordings of the target muscle.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients must have suffered from a stroke at least 12 weeks prior to their involvement in the trial
  • 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 absolute contraindications to chiropractic adjustments
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849794


Locations
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Pakistan
Riphah International University
Islamabad, Federal, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Imran Amjad, PhD Riphah International University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imran Amjad, Assistant Professor, Riphah International University
ClinicalTrials.gov Identifier: NCT03849794    
Other Study ID Numbers: RiphahIU Imran khan Niazi
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imran Amjad, Riphah International University:
Chronic Stroke
Chiropractic Care
Physiotherapy
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases