Clinical trial NCT03969277: Graded Motor Imagery in Elbow Limitation
Official title: The Effectiveness of Graded Motor Imagery Training in Elbow Limitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elbow Fracture
Limitation, Mobility
Pain, Postoperative
Upper Extremity Problem
Keywords: Imagery
Mirror Neurons
Immobilization
Exercise
Rehabilitation
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Functional Status
timeFrame: After the six-week intervention
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline
measure: Pain Intensity
timeFrame: After the six-week intervention
measure: Pain Intensity
timeFrame: 6-week follow-up
measure: Active Range of Motion (AROM) Assessment
timeFrame: Baseline
measure: Active Range of Motion (AROM) Assessment
timeFrame: After the six-week intervention
measure: Active Range of Motion (AROM) Assessment
timeFrame: 6-week follow-up
measure: Functional Status
timeFrame: Baseline
measure: Functional Status
timeFrame: 6-week follow-up
measure: Fear of movement (kinesiophobia)
timeFrame: Baseline
measure: Fear of movement (kinesiophobia)
timeFrame: After the six-week intervention
measure: Fear of movement (kinesiophobia)
timeFrame: 6-week follow-up
measure: Patient Satisfaction
timeFrame: After the six-week intervention
measure: Right-Left Discrimination
timeFrame: Baseline
measure: Right-Left Discrimination
timeFrame: After the six-week intervention
measure: Right-Left Discrimination
timeFrame: 6-week follow-up
measure: Vividness of Movement imagery Questionnaire-2 (VMIQ-2)
timeFrame: Baseline
measure: Pain pressure threshold
timeFrame: Baseline
measure: Pain pressure threshold
timeFrame: After the six-week intervention
measure: Pain pressure threshold
timeFrame: 6-week follow-up
measure: Muscle strength
timeFrame: After the six-week intervention
measure: Muscle strength
timeFrame: 6-week follow-up
measure: Grip strength
timeFrame: After the six-week intervention
measure: Grip strength
timeFrame: 6-week follow-up
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Bakırkoy
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.