- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06308211
Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program in Subacute Stroke Patients
Comparative Effects of Motor Imagery and Mirror Therapy Versus Motor Relearning Program on Balance, Motor Function and Activities of Daily Living in Subacute Stroke Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54660
- Muhammad kashif
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Stroke patient of both gender.
- Stroke patient of age 40-65 year .
- Patient diagnosis of cerebral ischemic stroke .
- Patients who had suffered a stroke with hemiplegia, were subacute at least 3 months to 5 months since the onset.
- Ability to walk with minimal assistance (functional ambulation category 1 to 3.
- Patient with score > 25 on mini-mental status examination.
Exclusion Criteria:
- Patients who presented with hemiplegic neglect or apraxia
- Patients with history of global or receptive aphasia
- Patients with history of psychological or emotional problems
- Patients with history of decompensated cardiovascular/ respiratory/ digestive/ renal disorders, biologic inflammatory syndrome, neoplastic disorders, neurogenic bladder or skin disorders (bedsores).
- Patients with history of artificial joints
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: GROUP A (MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY)
Group A will receive treatment session of 60 minutes including motor imagery for 20 minutes and mirror therapy for 20 minutes along with routine physical therapy of 20 minutes for 5 days per week for 12 weeks.In motor imagery subjects will watch the video and will be asked to close the eyes to focus and imagine how they are doing task they had previously observed 10 times and instructed to carry out the task in verbal commands given whenever necessary. In mirror therapy,The unaffected limb will be placed in front of the mirror and patient will try to make the identical motions with the paretic limb while moving the non-paretic limb during the session and routine physical therapy includes passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions). |
Subjects will be instructed to watch the video provided and recorded by investigator.In next step participants will be asked to close the eyes to focus and then to imagine how they are doing task they had previously observed 10 times.Participants will be than instructed to carry out the task in verbal commands given whenever necessary.The unaffected limb will be placed in front of the mirror so that the reflected illusion of the limb would be hallucinated to represent the affected limb and routine physical therapy includes passive and active assisted range of motion for the upper and lower extremity including the shoulder, forearm, wrist, hip, knee and ankle will be given (10 - 15 repititions).
Other Names:
|
|
Experimental: GROUP B (MOTOR RELEARNING PROGRAM+ROUTINE PHYSICAL THERAPY)
GROUP B will receive treatment session of 60 minutes including motor relearning program of 40 minutes duration along with routine physical therapy of 20 minutes as explained in group A protocol. Treatment session will be given 5 days per week for 12 weeks. Motor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training. |
Motor relearning consists of five components including analysis of task, practice of missing components, practice of task and transference of training. Patient will be asked to practice task in both sitting and standing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg balance scale (BBS)
Time Frame: 12th week
|
The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool.
Administering the BBS takes approximately 15 min.
Each of the 14 items are scored on a 5-level ordinal scale from 0 ("unable to perform or requiring help") to 4 ("normal performance"), thus providing a potential maximum score of 56 points
|
12th week
|
|
FUGL-MEYER ASSESMENT (FMA)
Time Frame: 12th week
|
The Fugl-Meyer Assessment is a welldesigned, feasible and efficient clinical examination method that has been tested widely in the stroke population.
A three-level ordinal scale (0, can perform no part of the test; 1, performs test partially; 2, performs test normally) is applied to each item.
A total possible score for the lower extremity is 34.
The higher the score, the better the performance.
|
12th week
|
|
FUNCTIONAL INDEPENDENCE MEASURE (FIM)
Time Frame: 12th week
|
The Functional Independence Measure (FIM) is one of the most frequently used outcome measures in stroke rehabilitation trials.
The five FIM items dealing with transfers and locomotion, including transfers to bed/chair/wheelchair, toileting, bathing, walking or wheelchair management and stairs, were used in this pilot study to evaluate the activities of daily living in the patients with stroke.
Each item is rated on a seven-level scale, with 1 = total assistance and 7 (complete independence).
By adding the points for each item in the transfers and locomotion, the possible total score ranges from 5 (lowest) to 35 (highest) level of independence; the higher the score, the better the independence.
This scale has good reliability for the assessment of recovery of function in stroke patients.
|
12th week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Muhammad Kashif, PhD, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0289
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
Clinical Trials on MOTOR IMAGERY+MIRROR THERAPY+ROUTINE PHYSICAL THERAPY
-
Riphah International UniversityCompleted
-
Elite College of Management Sciences, Gujranwala...Completed
-
Riphah International UniversityCompletedCerebral PalsyPakistan
-
Science and Research Centre KoperSlovenian Research AgencyCompletedOsteo Arthritis Knee | Knee ArthroplastySlovenia
-
Chang Gung Memorial HospitalNational Taiwan UniversityActive, not recruitingPeripheral Nerve InjuriesTaiwan
-
Riphah International UniversityRecruitingPain | Cervical Pain | KinesiophobiaPakistan
-
University of LahoreCompletedComplex Regional Pain SyndromePakistan
-
Riphah International UniversityCompleted
-
University of Roma La SapienzaCompletedFibromyalgia | Psychological Distress | Pain, Chronic | Image, BodyItaly
-
Ankara UniversityCompletedComplex Regional Pain Syndrome Type ITurkey