Clinical trial NCT06059755: Mirror Therapy vs Cross Education Non Paretic Limb Training on Strength and Hand Dexterity in Stroke Survivors.
Official title: Comparison of Mirror Therapy Versus Cross- Education Non Paretic Limb Training on Upper Limb Strength and Hand Dexterity in Stroke Survivors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia and Hemiparesis
Keywords: Paresis, Mirror therapy, Motor skills, Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 26
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A stroke is a significant contributor to functional decline and long-term disability. The reduction of obesity and improvement in quality of life are directly correlated. Many post-stroke patients experience persistent upper extremity dysfunction. The study aims to compare cross-education non-paretic limb training versus mirror therapy on upper limb strength and dexterous movement of hand in stroke survivors This randomized clinical trial will be conducted at DHQ Hospital Sargodha over a duration of six months. The sample size will consist of 26 participants. Participants which meet the inclusion criteria will be selected through Non probability convenience sampling technique, which will further be randomized through computer engendered in blocks by using basic number generator.13 participants will be assigned to Cross education group and 13 participants will be assigned to Mirror Therapy group. Data will be using various assessment tools, including the Action Research Arm Test (ARAT) for functional limitation, Fugl-Meyer Assessment-upper extremity (FMA-UE), Stroke Impact Scale (SIS) for hand dexterity and function. Hand held dynamometer will be used for Grip Strength Test. Pre intervention assessment will be conducted for both groups. The effects of intervention will be measured at pretreatment ,3rd week and post intervention. Data analysis will be performed by using SPSS (Statistical Package for Social Sciences) 23 version.

Detailed description: A stroke or CVA is characterized by the sudden onset of focal neurological dysfunction symptoms that persist for more than 24 hours (or cause death earlier) and are brought on by an acute vascular injury to a specific area of the brain. Overall, a stroke creates a blockage in the delivery of blood and oxygen to a particular region of the brain, which results in cell death, long-term or lifelong impairments, or even death. Issues with paralysis, motor control, pain-related sensory problems, language usage or comprehension, thinking, memory, and emotional challenges are just a few examples of disabilities.

Stroke can be ischemic or hemorrhagic. Over 100 diseases are associated with ischemic stroke, making it heterogeneous. It is the most common type of stroke and accounts for 87% of all strokes. Ischemic stroke is further divided into two groups; thrombotic stroke (the formation of clot or plaque in blood vessels within the brain) and embolic stroke (the formation of clot or plaque somewhere else in the body and travels to blood vessel of the brain through blood stream).

Atherosclerosis, arterial dissection, and artery-to-artery embolism are all examples of large vessel disease. The primary small vessel diseases causing lacunar strokes are lipohyalinosis and atherosclerosis. Intracerebral hemorrhage, which can occur deep (basal ganglia, brainstem), cerebellum, or lobar, accounts for about 15% of strokes. About 20% of intracerebral hemorrhages are brought on by macro vascular lesions (vascular malformations, aneurysms, cavernomas), venous sinus thrombosis, or other uncommon causes; these are particularly significant in young patients.

Literature review A systematic and evidence based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines. Search term for the initial literature review was post-stroke mirror therapy, post-stroke cross education, comparison of mirror therapy versus cross education non paretic limb training, upper limb strength and hand dexterity.

O. van der Groen et al. (2023) studied the Corticospinal and intracortical responses from both motor cortices following unilateral concentric versus eccentric contractions and compared responses to transcranial magnetic stimulation(TMS) in both motor cortices following single sessions of unilateral ECC and CON exercise of the elbow flexor and concluded that These findings suggest that responses after a single bout of exercise may not reflect longer term adaptations.

S. Karamat et al. (2022) compared the effects of task-based mirror therapy and Repetitive Facilitation Exercise on upper limb function in post stroke patient. The study concluded that mirror therapy and repetitive facilitation Exercise both were found to be effective in improving upper limb motor functions of acute stroke patients. However, Mirror therapy has shown significant effects in upper extremity functional index.

Eligibility criteria: Inclusion Criteria:

* • Age range between 45-65 years.

  * Both male and female genders.
  * Clinically diagnosed of stroke referred by Neuro physician.
  * Patients in the subacute stage, duration of 3 to 6 months from onset.
  * Patients with anterior cerebral artery (ACA) and middle cerebral artery (MCA) involvement with the affected side being the dominant side.
  * Patients with Mini-Mental State Examination (MMSE) score more than 16.
  * According to Modified Ashworth Scale, patients in range of 1 and 1+ (Flexor carpal radialis muscle,Flexor carpal ulnaris muscle, Flexor digitorum profundus muscle, Flexor digitorum superficialis muscle, Flexor pollicis longus muscle, Palmaris longus muscle) will be included .
  * Hemiparesis or hemiplegic due to Ischemic stroke

Exclusion Criteria:

* Patients with Alzheimer disease, Parkinson's disease, Multiple sclerosis and Brain tumors .
* Those with severe cognitive impairment , those who were unable to provide informed consent. Patients having acute pericarditis, lumbar puncture within 7 days, Major surgery or major trauma within 14 days.
* Patient with recurrent stroke.
* With unilateral neglect or apraxia

Primary outcomes:
measure: Action Research Arm Test (For Functional Limitation)
timeFrame: Changes from baseline Action Research Arm Test at 3rd week and after 6 weeks
measure: Fugl-Meyer Assessment. (For Upper extremity function)
timeFrame: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
measure: Hand-held dynamometer. (For Upper Limb strength assessment)
timeFrame: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
measure: Stroke Impact Scale (For hand function)
timeFrame: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Tehreem Mukhtar
state: Punjab
Study officials:
affiliation: Riphah International University
name: Kianat Rashid, MSPT-NM
role: PRINCIPAL_INVESTIGATOR
References: