NCT03969277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 8, 2024

Status Verified

June 1, 2021

Enrollment Period

12 months

First QC Date

May 29, 2019

Last Update Submit

October 5, 2024

Conditions

Keywords

ImageryMirror NeuronsImmobilizationExerciseRehabilitation

Outcome Measures

Primary Outcomes (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.

    After the six-week intervention

Secondary Outcomes (23)

  • Pain Intensity

    Baseline

  • Pain Intensity

    After the six-week intervention

  • Pain Intensity

    6-week follow-up

  • Active Range of Motion (AROM) Assessment

    Baseline

  • Active Range of Motion (AROM) Assessment

    After the six-week intervention

  • +18 more secondary outcomes

Study Arms (2)

Graded Motor Imagery

EXPERIMENTAL

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

Other: Graded Motor ImageryOther: Home Exercise ProgramOther: Cold Application

Standard Rehabilitation

ACTIVE COMPARATOR

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

Other: Standard RehabilitationOther: Home Exercise ProgramOther: Cold Application

Interventions

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.

Graded Motor Imagery

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.

Standard Rehabilitation

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

Graded Motor ImageryStandard Rehabilitation

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

Graded Motor ImageryStandard Rehabilitation

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 27858687BACKGROUND
  • 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.

    PMID: 29257926BACKGROUND
  • 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.

    PMID: 29122370BACKGROUND
  • 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.

    PMID: 21306870BACKGROUND
  • 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.

    PMID: 30304958BACKGROUND

Related Links

MeSH Terms

Conditions

Elbow FracturesMobility LimitationPain, PostoperativeMotor Activity

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, BoneSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsBehavior

Study Officials

  • Tansu Birinci, MSc

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc Research Assistant

Study Record Dates

First Submitted

May 29, 2019

First Posted

May 31, 2019

Study Start

October 15, 2019

Primary Completion

October 1, 2020

Study Completion

June 30, 2021

Last Updated

October 8, 2024

Record last verified: 2021-06

Locations