NCT05479942

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. 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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

July 21, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

July 21, 2022

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Recognise Online program

    The Recognise online application that displays different parts of the body that correspond to the patients' affected limb (left, right). During this portion of GMI, a patient is shown a group of images that correspond to the affected limb.four values for speed and four for the accuracy of responses corresponding to each patient for each treatment session

    up to 8 weeks

  • Flexible electronic goniometer

    To assess shoulder range of motion, while the patient was sitting down on a chair. The measurement involved the active flexion and abduction of the shoulder, with the upper limb starting from the neutral position.In each session, there were two measurements, The first was done at the beginning of the session and the second at the end of the session

    up to 8 weeks

  • The Shoulder Pain and Disability Index (SPADI)

    It is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder every session

    up to 8 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Study group

Other: Graded motor imagery training paradigmOther: conventional therapy (task-oriented active/passive range of motion training)

Group B

EXPERIMENTAL

Control group

Other: conventional therapy (task-oriented active/passive range of motion training)

Interventions

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 (Implicit motor imagery): 2. Explicit motor imagery 3. Mirror Therapy

Group A

Patient will do 3 tasks as: drinking water from a glass, lifting a glass of water to a level of 90° shoulder flexion with an extended elbow, moving 5 crystals from the table to a box, wiping the table with a towel with the elbow extended, grasping and releasing a 6 cm in diameter tennis ball, and combing their hairs. Practice shoulder flexion and abduction active ROM, and passive ROM training

Group AGroup B

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranges from 45 to 65 years old.
  • All patients suffer from shoulder pain post chronic stroke.
  • All patients received same kind of medications.
  • All patients have shoulder mild subluxation diagnosed by X- ray
  • \. All patients with modified Ashworth scale up to grade 2 muscle tone.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Baliana Central Hospital

Sohag, 82184, Egypt

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nawal Abo Shady, professor

    Professor of Physical Therapy Cairo University

    STUDY DIRECTOR

Central Study Contacts

Nawal Abo Shady, professor

CONTACT

Mohamed Sayed Ismael, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 29, 2022

Study Start

September 1, 2022

Primary Completion

May 30, 2023

Study Completion

November 1, 2023

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

All data will be available for improve clinical research

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after publication after july 2024 for ever
Access Criteria
free for all

Locations