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Elbow FractureNCT03969277

Graded Motor Imagery in Elbow Limitation

A study testing Graded Motor Imagery, Standard Rehabilitation and Home Exercise Program in people with Elbow Fracture and Limitation, Mobility, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 55 years
What is being tested?
Graded Motor Imagery, Standard Rehabilitation and Home Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Oct 2019to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpasa

    Istanbul, Bakırkoy, 34147

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of Graded Motor Imagery Training in Elbow Limitation

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.

Read the 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.

Being tested
Graded Motor Imagery, Standard Rehabilitation, Home Exercise Program, Cold Application
Keywords
Imagery, Mirror Neurons, Immobilization, Exercise, Rehabilitation
Medical subject headings
Elbow Fractures, Mobility Limitation, Pain, Postoperative, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Graded Motor ImageryOther

    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.

  • Standard RehabilitationOther

    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.

  • Home Exercise ProgramOther

    Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 6 weeks.

  • Cold ApplicationOther

    Cold application around the elbow joint for 15 minutes in every session.

Study groups in NCT03969277
Study groupRoleWhat they receive
Graded Motor ImageryExperimentalEach subject in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, and home exercises.
Receives: Other: Graded Motor Imagery; Other: Home Exercise Program; Other: Cold Application
Standard RehabilitationActive comparatorEach subject in the Standard Rehabilitation group will receive a treatment protocol consisting of stretching and strengthening exercises, cold therapy, and home exercises.
Receives: Other: Standard Rehabilitation; Other: Home Exercise Program; Other: Cold Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: After the six-week intervention

Secondary outcomes (23)
  1. 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.

    Measured: Baseline

  2. 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.

    Measured: After the six-week intervention

  3. 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.

    Measured: 6-week follow-up

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: After the six-week intervention

  6. 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.

    Measured: 6-week follow-up

  7. 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.

    Measured: Baseline

  8. 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.

    Measured: 6-week follow-up

  9. 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.

    Measured: Baseline

  10. 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.

    Measured: After the six-week intervention

  11. 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.

    Measured: 6-week follow-up

  12. 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.

    Measured: After the six-week intervention

  13. 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.

    Measured: Baseline

  14. 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.

    Measured: After the six-week intervention

  15. 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.

    Measured: 6-week follow-up

  16. 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.

    Measured: Baseline

  17. 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.

    Measured: Baseline

  18. 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.

    Measured: After the six-week intervention

  19. 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.

    Measured: 6-week follow-up

  20. 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.

    Measured: After the six-week intervention

  21. 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.

    Measured: 6-week follow-up

  22. 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.

    Measured: After the six-week intervention

  23. 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.

    Measured: 6-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2019
  2. Study start15 Oct 2019
  3. Primary completion1 Oct 2020
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03969277
Sponsor's protocol ID
141001
Status last verified
Jun 2021
First submitted
29 May 2019
Last updated
8 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27858687
  • 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.

    PubMed 29257926
  • 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.

    PubMed 29122370
  • 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.

    PubMed 21306870
  • 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.

    PubMed 30304958

Questions about this trial

What is this clinical trial studying?

A study testing Graded Motor Imagery, Standard Rehabilitation and Home Exercise Program in people with Elbow Fracture and Limitation, Mobility, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Status (time frame: After the six-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03969277, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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