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

NCT03849794 | Completed DMC

• 1 other identifier: RiphahIU Imran khan Niazi
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Stroke

Keywords

Chronic Stroke; Chiropractic Care; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment (FMA)

  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) \[\< 50 = Severe, 50-84 = Marked, 85-94 = Moderate and 95-99 = Slight \]

  baseline,4th week, 8th week

Secondary Outcomes (8)

• Stroke Specific Quality of Life Scale

  baseline,4th week, 8th week

• Modified Rankin Scale (mRS)

  baseline,4th week, 8th week

• Timed up and Go Test (TUG)

  baseline,4th week, 8th week

• Heart Rate Variability(HRV)

  baseline,4th week, 8th week

• Daily Movement

  1 Week

Other Outcomes (1)

• Transcranial Magnetic Stimulation (change in level of cortico-spinal cord excitability)

  1 Week

Study Arms (2)

Experimental group

EXPERIMENTAL

Chiropractic Care Plus Physiotherapy

Other: Experimental Group

Control group

ACTIVE COMPARATOR

Physiotherapy

Other: Control group

Interventions

Experimental Group OTHER

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.

Also known as: Chiropractic Care Plus Physiotherapy

Experimental group

Control group OTHER

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.

Also known as: Physiotherapy+sham Chiropractic

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (20)

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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.

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• 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.

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• 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.

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  PMID: 19833552 BACKGROUND

• 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.

  PMID: 34064209 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities; Control Groups

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Imran Amjad, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and the outcome assessors ( Physiotherapists), and data analysts will remain blinded to group allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 21, 2019
• Study Start: January 15, 2019
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)