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Graded Motor Imagery in Elbow Limitation

Primary Purpose

Elbow Fracture, Limitation, Mobility, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Graded Motor Imagery
Standard Rehabilitation
Home Exercise Program
Cold Application
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elbow Fracture focused on measuring Imagery, Mirror Neurons, Immobilization, Exercise, Rehabilitation

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects will be included with

  • Aged between 20 and 55 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
  • The "Standardized Mini Mental Test" result must be at least 24 points

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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Graded Motor Imagery

Standard Rehabilitation

Arm Description

Each subject in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, and home exercises.

Each subject in the Standard Rehabilitation group will receive a treatment protocol consisting of stretching and strengthening exercises, cold therapy, and home exercises.

Outcomes

Primary Outcome Measures

Functional Status
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 Outcome Measures

Pain Intensity
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
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
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
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
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
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
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
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)
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)
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)
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
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
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
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
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)
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
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
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
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
Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
Muscle strength
Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
Grip strength
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
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.

Full Information

First Posted
May 29, 2019
Last Updated
June 30, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT03969277
Brief Title
Graded Motor Imagery in Elbow Limitation
Official Title
The Effectiveness of Graded Motor Imagery Training in Elbow Limitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
To investigate the efficacy of GMI on function, pain, and ROM in elbow limitation, voluntary patients with elbow limitation, aged between 20-55 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 six-week 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 digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer of elbow flexors and extensors. Grip strength will also be assessed. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elbow Fracture, Limitation, Mobility, Pain, Postoperative, Upper Extremity Problem
Keywords
Imagery, Mirror Neurons, Immobilization, Exercise, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Graded Motor Imagery
Arm Type
Experimental
Arm Description
Each subject in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, and home exercises.
Arm Title
Standard Rehabilitation
Arm Type
Active Comparator
Arm Description
Each subject in the Standard Rehabilitation group will receive a treatment protocol consisting of stretching and strengthening exercises, cold therapy, and home exercises.
Intervention Type
Other
Intervention Name(s)
Graded Motor Imagery
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home Exercise Program
Intervention Description
Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Cold Application
Intervention Description
Cold application around the elbow joint for 15 minutes in every session.
Primary Outcome Measure Information:
Title
Functional Status
Description
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.
Time Frame
After the six-week intervention
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
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.
Time Frame
Baseline
Title
Pain Intensity
Description
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.
Time Frame
After the six-week intervention
Title
Pain Intensity
Description
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.
Time Frame
6-week follow-up
Title
Active Range of Motion (AROM) Assessment
Description
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.
Time Frame
Baseline
Title
Active Range of Motion (AROM) Assessment
Description
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.
Time Frame
After the six-week intervention
Title
Active Range of Motion (AROM) Assessment
Description
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.
Time Frame
6-week follow-up
Title
Functional Status
Description
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.
Time Frame
Baseline
Title
Functional Status
Description
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.
Time Frame
6-week follow-up
Title
Fear of movement (kinesiophobia)
Description
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.
Time Frame
Baseline
Title
Fear of movement (kinesiophobia)
Description
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.
Time Frame
After the six-week intervention
Title
Fear of movement (kinesiophobia)
Description
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.
Time Frame
6-week follow-up
Title
Patient Satisfaction
Description
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.
Time Frame
After the six-week intervention
Title
Right-Left Discrimination
Description
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.
Time Frame
Baseline
Title
Right-Left Discrimination
Description
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.
Time Frame
After the six-week intervention
Title
Right-Left Discrimination
Description
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.
Time Frame
6-week follow-up
Title
Vividness of Movement imagery Questionnaire-2 (VMIQ-2)
Description
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.
Time Frame
Baseline
Title
Pain pressure threshold
Description
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.
Time Frame
Baseline
Title
Pain pressure threshold
Description
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.
Time Frame
After the six-week intervention
Title
Pain pressure threshold
Description
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.
Time Frame
6-week follow-up
Title
Muscle strength
Description
Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
Time Frame
After the six-week intervention
Title
Muscle strength
Description
Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
Time Frame
6-week follow-up
Title
Grip strength
Description
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.
Time Frame
After the six-week intervention
Title
Grip strength
Description
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.
Time Frame
6-week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects will be included with Aged between 20 and 55 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 The "Standardized Mini Mental Test" result must be at least 24 points 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tansu Birinci, MSc
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Bakırkoy
ZIP/Postal Code
34147
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27858687
Citation
Mendez-Rebolledo G, Gatica-Rojas V, Torres-Cueco R, Albornoz-Verdugo M, Guzman-Munoz 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.
Results Reference
result
PubMed Identifier
29257926
Citation
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.
Results Reference
result
PubMed Identifier
29122370
Citation
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.
Results Reference
result
PubMed Identifier
21306870
Citation
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.
Results Reference
result
PubMed Identifier
30304958
Citation
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.
Results Reference
result

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Graded Motor Imagery in Elbow Limitation

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