Clinical trial NCT05479942: Graded Motor Imagery Training Paradigm on Shoulder Pain
Official title: Impact of Graded Motor Imagery Training Paradigm on Shoulder Pain and Quality of Life in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Complication
Lead sponsor: Merit University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 42
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Background: Shoulder pain is the most common pain disorder after stroke and one of the most common complications reduced quality of life. Graded Motor Imagery (GMI) is the most up to date rehabilitation program - based on the latest science and clinical trials - to treat many complex pain, and movement problems. Graded motor imagery is the psychological representation of attention doing movement of a part of body, without actually moving that part, it broken down into three unique stages of treatment techniques:

1. Left/right discrimination: The ability to identify left or right images of their painful body parts. This ability appears to be important for normal recovery from pain. The good news is that the brain is plastic and changeable, if given the right training for long enough.
2. Explicit motor imagery: Essentially thinking about moving without actually moving. Imagined movements can actually be hard work if in pain. This is most likely because 25 percent of the neurons in brain are 'mirror neurons' and start firing when thinking of moving or even watch someone else move. By imagining movements, use similar brain areas as actually move. This is why sports people imagine an activity before they do it.
3. Mirror therapy: If putting person left hand behind a mirror and right hand in front, person can trick brain into believing that the reflection of right hand in the mirror is left. Person is now exercising left hand in the brain, particularly if person start to move right hand. Graded motor imagery training has been suggested as a treatment technique that should be utilized in addressing shoulder pain and movement impairments following stroke.

Detailed description: Stroke is one of the main causes of mortality and disability in the world, and it was reported that about 15 million people suffer from stroke each year, which impose a heavy burden on social health care system. Meanwhile, shoulder pain after stroke, a common and disabling complication, with a prevalence of up to 12%-49%. Usually occurs two to three months after stroke and may result in withdrawal from rehabilitation programs, longer hospital stays, reduced limb function, impairing quality of life of the stroke patients adversely.

Stroke patients with poor upper extremity function have an increased risk of hemiplegic shoulder pain. Various theories have been proposed for the development of hemiplegic shoulder pain, including deficiency in pain adaption , central sensitization to normal or sub-threshold sensory stimuli, and impaired neuromuscular control of the scapula.

Graded motor imagery process from innovation of improved sensory cortex organization to targeted sensory discrimination exercise for clinical benefit has been frequent in complex regional pain syndrome (CRPS). Without eliciting the protective response of pain graded motor imagery slowly involves cortical motor networks. Excessively complex nociception system and the interrupted cortical mechanisms are only provided by graded motor imagery.

Graded motor imager (GMI) uses have 3 sequential stages for application. Left and right judgment which activates premotor cortex without activating primary motor areas is the first stage of graded motor imagery. Fictional movements which trigger motor cortical parts similar to those activated in actual accomplishment of movement is the second stage of graded motor imagery. Mirror therapy triggers not only motor cortex but also provides a strong visual input to the cortex in the third or final stage of graded motor imagery, though activation for each stage of GMI have been supported by brain imaging in healthy subjects.

Statement of the problem:

This study will try to answer the following question:

Will Graded motor imagery training paradigm be effective in the treatment of shoulder pain?

Purpose of the study:

The purpose of this study was designed to investigate the effect of graded motor imagery training paradigm in treatment shoulder pain and quality of life.

Significant of the study:

Shoulder pain is the most common pain disorder after stroke and one of the four most common complications. The estimated incidence ranges from of 30-70%. Shoulder pain is associated with reductions in function, interference with rehabilitation efforts, and a reduced quality of life.

Onset of shoulder pain is rapid, occurring as soon as a week after stroke in 17% of patients. While shoulder pain is ubiquitous, the management of shoulder pain represents a complex treatment pathway with insufficient evidence supporting one particular treatment .

Multiple factors contribute to normal shoulder positioning and function. Proper shoulder positioning involves a stabilized glenohumeral joint (actively and passively), appropriate glenoid fossa angle, and correct scapular and vertebral column alignment. The suprascapular nerve is not only vital to motor function, it provides up to 70% of the sensory fibers to the shoulder, and pain transmitted by the suprascapular nerve represents another potential underlying cause of shoulder pain.

Graded motor imagery it is very good method in pain management that organizes cortical activation and gradually decreases cortical disinhibition to prevent from acute pain to chronic pain.A non-randomized trial demonstrated some effect of GMI on motor function in patients with chronic stroke.

GMI has been extensively studied in chronic pain patients, especially chronic regional pain syndrome (CRPS) .It was developed to grade cortical activa¬tion and to reduce cortical disinhibition in CRPS. Cortical disinhibition is surely one of the patho-physio¬logical consequences of stroke that contributes to motor impairment. Stroke and CRPS have been compared on other grounds too.GMI has been suggested as a treatment technique that should be utilized in address¬ing movement impairments following stroke.

Graded motor imagery is the psychological representation of attention doing movement of a part of body, without actually moving that part. Because of this, it was intended to conclude the effects of graded motor imagery (GMI) training paradigm on shoulder pain and disability in chronic stroke patients.

Delimitations:

Patients were delimited to:

1. Forty two patients who had chronic Stroke.
2. Age ranged from 45 to 65 years old males and females.
3. The patients were randomly divided into two groups of equal number.
4. Patients have shoulder pain and functional disability due to chronic stroke.
5. Patients will be assessed via Recognise Online program for speed and accuracy of responses, Shoulder Pain and Disability Index (SPADI) for pain and function, and electrical goniometer for shoulder Range of Motion (ROM).
6. Patients will receive Graded motor imagery training paradigm and conventional therapy (task-oriented active/passive range of motion training).

Basic Assumption:

It was assumed that:

1. All patients followed the instructions that were given to them.
2. The measurement tools were reliable and valid.
3. All patients were free from cognitive or psychological disorders.
4. All patients were free from any systemic disease or its complication that affects the therapeutic out.

Hypothesis:

There was no effect of Graded motor imagery on shoulder pain and quality of life in patients with chronic stroke

Eligibility criteria: Inclusion Criteria:

1. Age ranges from 45 to 65 years old.
2. All patients suffer from shoulder pain post chronic stroke.
3. All patients received same kind of medications.
4. All patients have shoulder mild subluxation diagnosed by X- ray

4. All patients with modified Ashworth scale up to grade 2 muscle tone.

Exclusion Criteria:

1. Patient who suffers from shoulder stiffness post chronic stroke.
2. Patient who suffers from bilateral shoulder pain due to multiple stroke.
3. Patient who suffers from loss of hand movement post stroke.
4. Patient who suffers from mental or psychological disorders.
5. Patient dropped out through the study more than three sessions.
6. Patient who suffers from any systemic disease that may interfere with the objectives of the study

Primary outcomes:
measure: Recognise Online program
timeFrame: up to 8 weeks
measure: Flexible electronic goniometer
timeFrame: up to 8 weeks
measure: The Shoulder Pain and Disability Index (SPADI)
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: El Baliana Central Hospital
Study officials:
affiliation: Professor of Physical Therapy Cairo University
name: Nawal Abo Shady, professor
role: STUDY_DIRECTOR
References: