Hemiplegia and HemiparesisNCT06059755
Mirror Therapy vs Cross Education Non Paretic Limb Training on Strength and Hand Dexterity in Stroke Survivors.
A study testing Cross education and Mirror Therapy in people with Hemiplegia and Hemiparesis, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hemiplegia and Hemiparesis
- What is being tested?
- Cross education and Mirror Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Tehreem Mukhtar
Lahore, Punjab Province, 54000
Tehreem Mukhtar, PhD, +923134715275, tehreem.mukhtar@riphah.edu.pk
About this study
Official title: Comparison of Mirror Therapy Versus Cross- Education Non Paretic Limb Training on Upper Limb Strength and Hand Dexterity in Stroke Survivors.
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.
Read the 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.
- 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.
- 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.
- Conditions
- Hemiplegia and Hemiparesis
- Being tested
- Cross education, Mirror Therapy
- Keywords
- Paresis, Mirror therapy, Motor skills, Stroke
- Medical subject headings
- Hemiplegia, Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross educationOther
For strength training resistance exercises with a load of 60% of one repetition maximum will be performed targeting the muscle involved in upper limb function. Strength will be measured using the grip strength test/hand held dynamometer. Patients will undergo 45 minute session per day, 3 days per week for 6 weeks.
Mirror TherapyOther
Participants will be asked to sit in front of a table of appropriate height with their arms resting on the table and a mirror (35 cm × 35 cm) placed between the patient's arms. The non-affected arm will be placed in front of the mirror and the affected arm will be placed and obscured. Appropriate movement tasks will be selected according to the function of the affected upper limb. This exercise will be performed 45 minutes per day, 3 times per week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A: Cross education | Experimental | For strength training resistance exercises with a load of 60% of one repetition maximum will be performed targeting the muscles involved in upper limb function. It includes exercises like shoulder presses, wrist curls, elbow flexion, and triceps extensions. Among the functional movements that are the focus of motor skill training activities for non-paretic limbs are reaching, gripping, and object manipulation. Patient will be encouraged to mentally visualize themselves performing movements and tasks with the affected limb, while actively engaging the non-paretic limb. Strength will be measured using the grip strength test/ hand held dynamometer. Patients will undergo 45-minute session per day, 3 days per week for 6 weeks. Receives: Other: Cross education |
| Group B: Mirror Therapy | Experimental | Participants will be asked to sit in front of a table of appropriate height with their arms resting on the table and a mirror (35 cm × 35 cm) placed between the patient's arms. The non-affected arm will be placed in front of the mirror and the affected arm will be placed and obscured. Patient will engage in specific exercises or movements using the affected limb while observing the mirror reflection. The movements will consist of forearm rotation, elbow, wrist, and finger flexion and extension movements, and hand grasping. Appropriate movement tasks will be selected according to the function of the affected upper limb. This exercise will be performed 45 minutes per day, 3 times per week for 6 weeks. Receives: Other: Mirror Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (For Functional Limitation)
The instrument contains 19 items grouped into 4 subtests; grasp, grip, pinch, and gross motor. Item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) then item ratings are summed and reported out of 57 points with higher score indicating greater UE function.
Measured: Changes from baseline Action Research Arm Test at 3rd week and after 6 weeks
Fugl-Meyer Assessment. (For Upper extremity function)
The Fugl-Meyer Assessment is the gold standard to assess motor function of post-stroke hemiparesis. The FMA-UE consists of 30 items assessing motor function and 3 items assessing reflex function. The scores most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).Higher the score more is the independence.
Measured: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
Hand-held dynamometer. (For Upper Limb strength assessment)
This instrument is scored using force produced in kilograms (0-90) or pounds (0-200). The subject is seated with back, pelvis and knees as close to 90 degrees as possible, shoulder is adducted and neutrally rotated, elbow flexed to 90 degrees, and forearm neutral and wrist held between 0-15 degrees of ulnar deviation. Maximum grip is the mean of 3 trails.
Measured: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
Stroke Impact Scale (For hand function)
The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. It contains 59 items and assesses 8 domains: Strength - 4 items, Hand function - 5 items, ADL/IADL - 10 items, Mobility - 9 items, Communication - 7 items, Emotion - 9 items, Memory and thinking - 7 items, Participation/Role function - 8 items. For each item individual is asked to rate the level of difficulty in past two weeks using the scale;1= extremely difficult, 2= very difficult, 3= somewhat difficult, 4= a little difficult, 5= not difficult at all. On a scale of 0 to 100, with 100 representing full recovery and 0 representing no recovery.
Measured: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegia and HemiparesisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kianat Rashid, MSPT-NM, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059755
- Sponsor's protocol ID
- RiphahIU Kainat Rashid
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mirror Therapy Versus Cross- Education Non Paretic Limb Training on Upper Limb Strength and Hand Dexterity in Stroke Survivors.
- ClinicalTrials.gov ID
- NCT06059755
- Acronym / sponsor ID
- RiphahIU Kainat Rashid
- Conditions
- Hemiplegia and Hemiparesis
- Keywords
- Paresis, Mirror therapy, Motor skills, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Cross education | Experimental | Other: Cross educationFor strength training resistance exercises with a load of 60% of one repetition maximum will be performed targeting the muscles involved in upper limb function. It includes exercises like shoulder presses, wrist curls, elbow flexion, and triceps extensions. Among the functional movements that are the focus of motor skill training activities for non-paretic limbs are reaching, gripping, and object manipulation. Patient will be encouraged to mentally visualize themselves performing movements and tasks with the affected limb, while actively engaging the non-paretic limb. Strength will be measured using the grip strength test/ hand held dynamometer. Patients will undergo 45-minute session per day, 3 days per week for 6 weeks. |
| Group B: Mirror Therapy | Experimental | Other: Mirror TherapyParticipants will be asked to sit in front of a table of appropriate height with their arms resting on the table and a mirror (35 cm × 35 cm) placed between the patient's arms. The non-affected arm will be placed in front of the mirror and the affected arm will be placed and obscured. Patient will engage in specific exercises or movements using the affected limb while observing the mirror reflection. The movements will consist of forearm rotation, elbow, wrist, and finger flexion and extension movements, and hand grasping. Appropriate movement tasks will be selected according to the function of the affected upper limb. This exercise will be performed 45 minutes per day, 3 times per week for 6 weeks. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Age range between 45-65 years.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross educationFor strength training resistance exercises with a load of 60% of one repetition maximum will be performed targeting the muscle involved in upper limb function. Strength will be measured using the grip strength test/hand held dynamometer. Patients will undergo 45 minute session per day, 3 days per week for 6 weeks. | Other | Group A: Cross education |
| Mirror TherapyParticipants will be asked to sit in front of a table of appropriate height with their arms resting on the table and a mirror (35 cm × 35 cm) placed between the patient's arms. The non-affected arm will be placed in front of the mirror and the affected arm will be placed and obscured. Appropriate movement tasks will be selected according to the function of the affected upper limb. This exercise will be performed 45 minutes per day, 3 times per week for 6 weeks | Other | Group B: Mirror Therapy |
Primary outcome
Action Research Arm Test (For Functional Limitation)
Time frame: Changes from baseline Action Research Arm Test at 3rd week and after 6 weeks
The instrument contains 19 items grouped into 4 subtests; grasp, grip, pinch, and gross motor. Item performance is rated on a 4-point scale (0=unable; 1=partial; 2= abnormal; 3=normal) then item ratings are summed and reported out of 57 points with higher score indicating greater UE function.
Fugl-Meyer Assessment. (For Upper extremity function)
Time frame: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
The Fugl-Meyer Assessment is the gold standard to assess motor function of post-stroke hemiparesis. The FMA-UE consists of 30 items assessing motor function and 3 items assessing reflex function. The scores most applicable to task performance is given from "0, inability," "1, beginning ability," to "2, normal" (total score range, 0-66).Higher the score more is the independence.
Hand-held dynamometer. (For Upper Limb strength assessment)
Time frame: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
This instrument is scored using force produced in kilograms (0-90) or pounds (0-200). The subject is seated with back, pelvis and knees as close to 90 degrees as possible, shoulder is adducted and neutrally rotated, elbow flexed to 90 degrees, and forearm neutral and wrist held between 0-15 degrees of ulnar deviation. Maximum grip is the mean of 3 trails.
Stroke Impact Scale (For hand function)
Time frame: Changes from baseline Fugl-Meyer Assessment at 3rd week and after 6 weeks
The Stroke Impact Scale (SIS) is a stroke-specific, self-report, health status measure. It contains 59 items and assesses 8 domains: Strength - 4 items, Hand function - 5 items, ADL/IADL - 10 items, Mobility - 9 items, Communication - 7 items, Emotion - 9 items, Memory and thinking - 7 items, Participation/Role function - 8 items. For each item individual is asked to rate the level of difficulty in past two weeks using the scale;1= extremely difficult, 2= very difficult, 3= somewhat difficult, 4= a little difficult, 5= not difficult at all. On a scale of 0 to 100, with 100 representing full recovery and 0 representing no recovery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kianat Rashid, MSPT-NM principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross education and Mirror Therapy in people with Hemiplegia and Hemiparesis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tehreem Mukhtar, PhD* (+923134715275, tehreem.mukhtar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (For Functional Limitation) (time frame: Changes from baseline Action Research Arm Test at 3rd week and after 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.