Graded Motor Imagery in Elbow Limitation

Overview

This randomized-controlled trial aims to investigate the efficacy of Graded Motor Imagery (GMI) on function, pain, and range of motion (ROM) in patients with a posttraumatic stiff elbow.

Full Title of Study: “The Effectiveness of Graded Motor Imagery Training in Elbow Limitation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2020

Detailed Description

To investigate the efficacy of GMI on function, pain, and ROM in elbow limitation, forty-two voluntary patients with elbow limitation, aged between 18-65 years will be randomly divided into two groups: GMI group and standard rehabilitation (SR) group. Interventions will be applied for 12 sessions. The patients will be assessed before, after six-week treatment and one-month follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. ROM will be assessed with a universal goniometer. Isometric muscle strength will be measured with a handheld dynamometer of four muscle groups (elbow flexors and extensors, and wrist flexors and extensors). Grip strength will also be assessed. The Jebsen-Taylor Hand Function Test will establish to provide a standardized and objective evaluation of fine and gross motor hand. Recognise™ will be used for assessing the right-left discrimination. The functional status and kinesiophobia will be evaluated by Disabilities Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia, respectively. The Global Rating of Change will be used to evaluate patient satisfaction. The Vividness of Movement Imagery Questionnaire 2 (VMIQ-2) will be used for evaluating the individuals' ability to mental imaginary.

Interventions

  • Other: Graded Motor Imagery
    • The first stage of GMI includes laterality reconstruction. Patients will view and determine if the various images of body parts to image portrays the right or left side. The second stage targets activation of the primary motor cortex by imagine moving the involved body part. The final stage involves that the patient watches the unaffected body part moving in a mirror to “trick” the brain into thinking the affected body part is actually moving in a pain-free way. This will be applied for 6 weeks.
  • Other: Standard Rehabilitation
    • Shoulder, elbow and wrist AROM exercises. Elbow flexion and extension, and wrist flexion and extension stretching exercises. Elbow and wrist strengthening exercises. Grip strengthening exercises. This will be applied for 6 weeks.
  • Other: Home Exercise Program
    • Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 4 weeks.
  • Other: Cold Application
    • Cold application around the elbow joint for 15 minutes in every session.

Arms, Groups and Cohorts

  • Experimental: Graded Motor Imagery
    • Each subject in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, and home exercises.
  • Active Comparator: Standard Rehabilitation
    • Each subject in the Standard Rehabilitation group will receive a treatment protocol consisting of stretching and strengthening exercises, cold therapy, and home exercises.

Clinical Trial Outcome Measures

Primary Measures

  • Functional Status
    • Time Frame: After the six-week intervention
    • The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.

Secondary Measures

  • Pain Intensity
    • Time Frame: Baseline
    • Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
  • Pain Intensity
    • Time Frame: After the six-week intervention
    • Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
  • Pain Intensity
    • Time Frame: 1-month follow up
    • Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
  • Active Range of Motion (AROM) Assessment
    • Time Frame: Baseline
    • The elbow’s and forearm’s AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Active Range of Motion (AROM) Assessment
    • Time Frame: After the six-week intervention
    • The elbow’s and forearm’s AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Active Range of Motion (AROM) Assessment
    • Time Frame: 1-month follow up
    • The elbow’s and forearm’s AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Functional Status
    • Time Frame: Baseline
    • The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
  • Functional Status
    • Time Frame: 1-month follow up
    • The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
  • Fear of movement (kinesiophobia)
    • Time Frame: Baseline
    • Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
  • Fear of movement (kinesiophobia)
    • Time Frame: After the six-week intervention
    • Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
  • Fear of movement (kinesiophobia)
    • Time Frame: 1-month follow up
    • Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
  • Patient Satisfaction
    • Time Frame: After the six-week intervention
    • Patient satisfaction regarding improvement in elbow function will be assessed by the Global Rating of Change scale. The participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.
  • Right-Left Discrimination
    • Time Frame: Baseline
    • Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients’ ability to quickly and accurately recognise an image of a body area as either left or right (‘Left/Right Discrimination’). The test will be repeated three times and average values will be recorded.
  • Right-Left Discrimination
    • Time Frame: After the six-week intervention
    • Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients’ ability to quickly and accurately recognise an image of a body area as either left or right (‘Left/Right Discrimination’). The test will be repeated three times and average values will be recorded.
  • Right-Left Discrimination
    • Time Frame: 1-month follow up
    • Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients’ ability to quickly and accurately recognise an image of a body area as either left or right (‘Left/Right Discrimination’). The test will be repeated three times and average values will be recorded.
  • Vividness of Movement imagery Questionnaire-2 (VMIQ-2)
    • Time Frame: Baseline
    • The Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) will be used to measure the vividness of imagery. It comprises three subscales and 12 core questions that are scored on a 5-point Likert-type scale (Perfectly clear and as vivid (as normal vision or feel of movement) – No image at all, you only “know” that you are thinking of the skill). The subscales scores (External Visual Imagery, Internal Visual Imagery, and Kinaesthetic imagery) are ranged from 1 to 60, where the higher scores indicate a decreased ability of vividness of imagery.
  • Pain pressure threshold
    • Time Frame: Baseline
    • Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.
  • Pain pressure threshold
    • Time Frame: After the six-week intervention
    • Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.
  • Pain pressure threshold
    • Time Frame: 1-month follow up
    • Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.
  • Muscle strength
    • Time Frame: After the six-week intervention
    • Isometric muscle strength will be measured with a handheld dynamometer of four muscle groups (elbow flexors and extensors, and wrist flexors and extensors). The process will be repeated three times in each direction, with the average value recorded.
  • Muscle strength
    • Time Frame: 1-month follow up
    • Isometric muscle strength will be measured with a handheld dynamometer of four muscle groups (elbow flexors and extensors, and wrist flexors and extensors). The process will be repeated three times in each direction, with the average value recorded.
  • Grip strength
    • Time Frame: After the six-week intervention
    • Grip strength will be assessed with JAMAR hydraulic hand dynamometer. The process will be repeated three times in each direction, with the average value recorded.
  • Grip strength
    • Time Frame: 1-month follow up
    • Grip strength will be assessed with JAMAR hydraulic hand dynamometer. The process will be repeated three times in each direction, with the average value recorded.
  • Fine and gross motor hand function
    • Time Frame: Baseline
    • The Jebsen-Taylor Hand Function Test will establish to provide a standardized and objective evaluation of fine and gross motor hand. The tests will be performed on non-dominant and dominant hand respectively. For each subtest, one practice trial will be given for familiarization, followed by 2 test trials. Rest will be given after completion of each subtest. The outcome measure will be the time taken to finish each subtest and the total time taken to complete the whole the Jebsen-Taylor Hand Function Test, with a lower score indicating greater dexterity.
  • Fine and gross motor hand function
    • Time Frame: After the six-week intervention
    • The Jebsen-Taylor Hand Function Test will establish to provide a standardized and objective evaluation of fine and gross motor hand. The tests will be performed on non-dominant and dominant hand respectively. For each subtest, one practice trial will be given for familiarization, followed by 2 test trials. Rest will be given after completion of each subtest. The outcome measure will be the time taken to finish each subtest and the total time taken to complete the whole the Jebsen-Taylor Hand Function Test, with a lower score indicating greater dexterity.
  • Fine and gross motor hand function
    • Time Frame: 1-month follow up
    • The Jebsen-Taylor Hand Function Test will establish to provide a standardized and objective evaluation of fine and gross motor hand. The tests will be performed on non-dominant and dominant hand respectively. For each subtest, one practice trial will be given for familiarization, followed by 2 test trials. Rest will be given after completion of each subtest. The outcome measure will be the time taken to finish each subtest and the total time taken to complete the whole the Jebsen-Taylor Hand Function Test, with a lower score indicating greater dexterity.

Participating in This Clinical Trial

Inclusion Criteria

Subjects will be included with

  • Aged between 18 and 65 years – Elbow fracture in the six months before the study – Elbow limitation in flexion or extension – Being a volunteer to participate – Fractures should be managed with surgically Exclusion Criteria:
  • Malunion or Nonunion Fracture – The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing – Non-healing wound or infection – Previously received physiotherapy for elbow limitation – Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases – Could not adjust to the treatment – Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity – Having severe visual loss
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 65 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Istanbul University-Cerrahpasa
    • Provider of Information About this Clinical Study
      • Principal Investigator: Tansu Birinci, PT, MSc Research Assistant – Istanbul University-Cerrahpasa
    • Overall Official(s)
      • Tansu Birinci, MSc, Principal Investigator, Istanbul University-Cerrahpasa

    Citations Reporting on Results

    Méndez-Rebolledo G, Gatica-Rojas V, Torres-Cueco R, Albornoz-Verdugo M, Guzmán-Muñoz E. Update on the effects of graded motor imagery and mirror therapy on complex regional pain syndrome type 1: A systematic review. J Back Musculoskelet Rehabil. 2017;30(3):441-449. doi: 10.3233/BMR-150500. Review.

    Sawyer EE, McDevitt AW, Louw A, Puentedura EJ, Mintken PE. Use of Pain Neuroscience Education, Tactile Discrimination, and Graded Motor Imagery in an Individual With Frozen Shoulder. J Orthop Sports Phys Ther. 2018 Mar;48(3):174-184. doi: 10.2519/jospt.2018.7716. Epub 2017 Dec 19.

    Dilek B, Ayhan C, Yagci G, Yakut Y. Effectiveness of the graded motor imagery to improve hand function in patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jan – Mar;31(1):2-9.e1. doi: 10.1016/j.jht.2017.09.004. Epub 2017 Nov 6.

    Priganc VW, Stralka SW. Graded motor imagery. J Hand Ther. 2011 Apr-Jun;24(2):164-8; quiz 169. doi: 10.1016/j.jht.2010.11.002. Epub 2011 Feb 9.

    Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):241-252. doi: 10.1177/0269215518802886. Epub 2018 Oct 10.

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