StrokeNCT05053529
Mirror Therapy and CIMT in Chronic Stroke Patients
A study testing Mirror therapy and CIMT group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to find and compare the effect of mirror therapy and constrained induced movement therapy in upper limb rehabilitation among chronic stroke patient .Study conducted in THQ Hospital Depalpur. The sample size was 36. Patients were divided into two groups. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Mirror therapy and CIMT group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2019to 30 Apr 2020
- 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 ranges between 40-65 years.
- Chronic stroke (ischemic/hemorrhagic) more than 6 months.
- Ability to participate in a therapy session lasting at least 3 minutes.
- Chronic stroke with mild spasticity (score of 2 or less on Modified Ashworth Scale).
- Good cognitive function (score of 20 or more in Mini Mental state Examination).
- Range of motion of about 10º or 20º (measured with Goniometer)
Who cannot join
- Patients with orthopedic conditions like fractures, etc.
- Subjects presenting with unable to follow visual command.
- Language deficits that could prevent them from following instructions.
- Age group below 45 years and more than 65 years
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Mirror Therapy and Constrained Induced Movement Therapy in Upper Limb Rehabilitation Among Chronic Stroke Patients.
The aim of this research is to find and compare the effect of mirror therapy and constrained induced movement therapy in upper limb rehabilitation among chronic stroke patient .Study conducted in THQ Hospital Depalpur. The sample size was 36. Patients were divided into two groups. In group-A patients were treated with mirror therapy and in group-B patients were treated with constrained induced movement therapy. Both therapy sessions lasting for 60 minutes for total 1 hour in a day, 5 times a week and for consecutive 3 weeks in a month. Sessions consist of total 20 min of passive mobilization to both groups, 30 min session for MMT to 1 group, 30 min session to CIMT (task specific) to another group, and 10 minutes standard ADL activities. The outcome was calculated with FMA-UE and modified Ashworth scale. Data was analyzed by SPSS 22.
Read the detailed description
Worldwide stroke affects mostly aged population and thus leads to morbidity and mortality.
According to world health organization stroke causes second most common cases of death and a leading cause of morbidity in adults. Most developed countries are more affected with stroke as compared to developing region around the world. Based on WHO record, estimated annual death rates with stroke was 5.5 million. For optimal functioning, Brain requires sufficient supply of blood and for this carotid arteries are responsible for supplying oxygen rich blood to different areas of the brain. As an individual breathes, the brain consumes 20% of oxygen, which allows it to work efficiently. As in the case of a stroke, brain cells die quickly when there is a blockage or obstruction of oxygen to the brain by impeded blood flow. Blood plaques or clots disrupts oxygen rich supply to the brain in ischemic stroke leads to brain cell death. Whereas, sudden rupturing of blood vessels leads to cell death in hemorrhagic stoke. Most studies showed that task specific motor programs an repetition of movements on both upper and lower limbs are more effective interventions14. Various other treatment protocols are also used for improving limb functions, like visual feedback training, assistive robotic training, Functional Electrical Stimulator (FES) and Constrained Induced Movement Therapy (CIMT). These therapies help in improving motor performance from the affected side of stroke patients. Uni-manual, high intensity training known as Constrained Induced Movement Therapy or forced use is reported as an effective treatment for training the motor cortex areas. Task specific or bi-manual programs with rhythmic auditory clues were also included in this training to improve motor functions. Researcher conducted a latest study in 2019 by random sampling method to find the effect of mirror therapy for upper limb rehabilitation. They allocate the participants randomly into three groups based on movement mirror therapy (MMT), task specific mirror therapy (TMT) and conventional therapy (CT). The session consists of 30 minutes a day, 5 days in a week and for total 4 weeks. Performance was measured by FMA-UE, Wolf motor assessment and modified Ash worth scale. The results were the same for both MMT and TMT for upper limb rehabilitation. In 2018 Yumi Ju et al. Conducted study in the Korea to examine the effectiveness of mirror therapy and constrained induced movement therapy for the rehabilitation of the upper extremity for daily life activities. 28 subjects were randomly placed to a weekly session of 5 days and for consecutive 3 weeks. Performance was measured by Manual Function Test (MFT) and Modified Barthel Index(BI) to find the factor which is affecting the activities of daily livings. They concluded that patients actively participate in activities of daily livings by actively moving their affected. Previous researches based on the effectiveness of mirror therapy and constrained induced movement therapy alone or combined with other rehabilitative therapies for improving upper limb rehabilitation in different patients having neurological impairments. Their outcomes were evaluated on different outcome measurement tools and their were significant improvement in patients functional independence and had good quality of life.
- Conditions
- Stroke
- Being tested
- Mirror therapy, CIMT group
- Keywords
- Mirror therapy ,Constrained induced movement therapy, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyOther
Session consist of total 1hour,20 min of passive mobilization, 30 minutes for Movement mirror therapy,10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month.
CIMT groupOther
Session consist of total 1hour ,20 min of passive mobilization, 30 min session to CIMT and 10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month.
| Study group | Role | What they receive |
|---|---|---|
| Mirror therapy | Experimental | Session consist of total 1hour,20 min of passive mobilization, 30 minutes for Movement mirror therapy,10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month. Receives: Other: Mirror therapy |
| Constrained induced movement therapy (CIMT) | Experimental | Session consist of total 1hour ,20 min of passive mobilization, 30 min session to CIMT and 10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month. Receives: Other: CIMT group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugyl Myer assessment tool for upper extremity
The Fugyl Myer assessment (FMA) motor assessments for the upper (maximum score 66 points) and lower extremity (maximum score 34 points) are recommended as core measures to be used in every stroke recovery and rehabilitation trial. Change from baseline FMA at 3 weeks
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start15 Jun 2019
- Primary completion20 Feb 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehreem Mukhtar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053529
- Sponsor's protocol ID
- REC/Lhr/2022 Sitara Nasir
- Status last verified
- Sep 2021
- First submitted
- 23 Aug 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park JY, Chang M, Kim KM, Kim HJ. The effect of mirror therapy on upper-extremity function and activities of daily living in stroke patients. J Phys Ther Sci. 2015 Jun;27(6):1681-3. doi: 10.1589/jpts.27.1681. Epub 2015 Jun 30.
PubMed 26180297Broderick P, Horgan F, Blake C, Ehrensberger M, Simpson D, Monaghan K. Mirror therapy and treadmill training for patients with chronic stroke: a pilot randomized controlled trial. Top Stroke Rehabil. 2019 Apr;26(3):163-172. doi: 10.1080/10749357.2018.1556504. Epub 2018 Dec 22.
PubMed 30580672Ackerley SJ, Byblow WD, Barber PA, MacDonald H, McIntyre-Robinson A, Stinear CM. Primed Physical Therapy Enhances Recovery of Upper Limb Function in Chronic Stroke Patients. Neurorehabil Neural Repair. 2016 May;30(4):339-48. doi: 10.1177/1545968315595285. Epub 2015 Jul 15.
PubMed 26180053Teasell R, Mehta S, Pereira S, McIntyre A, Janzen S, Allen L, Lobo L, Viana R. Time to rethink long-term rehabilitation management of stroke patients. Top Stroke Rehabil. 2012 Nov-Dec;19(6):457-62. doi: 10.1310/tsr1906-457.
PubMed 23192711Lee JS, Lee HG. Effects of sling exercise therapy on trunk muscle activation and balance in chronic hemiplegic patients. J Phys Ther Sci. 2014 May;26(5):655-9. doi: 10.1589/jpts.26.655. Epub 2014 May 29.
PubMed 24926126Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.
PubMed 25772900Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
PubMed 21051765Nasb M, Li Z, S A Youssef A, Dayoub L, Chen H. Comparison of the effects of modified constraint-induced movement therapy and intensive conventional therapy with a botulinum-a toxin injection on upper limb motor function recovery in patients with stroke. Libyan J Med. 2019 Dec;14(1):1609304. doi: 10.1080/19932820.2019.1609304.
PubMed 31032717Stark A, Farber C, Tetzlaff B, Scherer M, Barzel A. Stroke patients' and non-professional coaches' experiences with home-based constraint-induced movement therapy: a qualitative study. Clin Rehabil. 2019 Sep;33(9):1527-1539. doi: 10.1177/0269215519848813. Epub 2019 May 20.
PubMed 31104476
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mirror Therapy and Constrained Induced Movement Therapy in Upper Limb Rehabilitation Among Chronic Stroke Patients.
- ClinicalTrials.gov ID
- NCT05053529
- Acronym / sponsor ID
- REC/Lhr/2022 Sitara Nasir
- Conditions
- Stroke
- Keywords
- Mirror therapy ,Constrained induced movement therapy, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 22 Sep 2021 (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.
The aim of this research is to find and compare the effect of mirror therapy and constrained induced movement therapy in upper limb rehabilitation among chronic stroke patient .Study conducted in THQ Hospital Depalpur. The sample size was 36. Patients were divided into two groups. In group-A patients were treated with mirror therapy and in group-B patients were treated with constrained induced movement therapy. Both therapy sessions lasting for 60 minutes for total 1 hour in a day, 5 times a week and for consecutive 3 weeks in a month. Sessions consist of total 20 min of passive mobilization to both groups, 30 min session for MMT to 1 group, 30 min session to CIMT (task specific) to another group, and 10 minutes standard ADL activities. The outcome was calculated with FMA-UE and modified Ashworth scale. Data was analyzed by SPSS 22.
Detailed description
Worldwide stroke affects mostly aged population and thus leads to morbidity and mortality.
According to world health organization stroke causes second most common cases of death and a leading cause of morbidity in adults. Most developed countries are more affected with stroke as compared to developing region around the world. Based on WHO record, estimated annual death rates with stroke was 5.5 million. For optimal functioning, Brain requires sufficient supply of blood and for this carotid arteries are responsible for supplying oxygen rich blood to different areas of the brain. As an individual breathes, the brain consumes 20% of oxygen, which allows it to work efficiently. As in the case of a stroke, brain cells die quickly when there is a blockage or obstruction of oxygen to the brain by impeded blood flow. Blood plaques or clots disrupts oxygen rich supply to the brain in ischemic stroke leads to brain cell death. Whereas, sudden rupturing of blood vessels leads to cell death in hemorrhagic stoke. Most studies showed that task specific motor programs an repetition of movements on both upper and lower limbs are more effective interventions14. Various other treatment protocols are also used for improving limb functions, like visual feedback training, assistive robotic training, Functional Electrical Stimulator (FES) and Constrained Induced Movement Therapy (CIMT). These therapies help in improving motor performance from the affected side of stroke patients. Uni-manual, high intensity training known as Constrained Induced Movement Therapy or forced use is reported as an effective treatment for training the motor cortex areas. Task specific or bi-manual programs with rhythmic auditory clues were also included in this training to improve motor functions. Researcher conducted a latest study in 2019 by random sampling method to find the effect of mirror therapy for upper limb rehabilitation. They allocate the participants randomly into three groups based on movement mirror therapy (MMT), task specific mirror therapy (TMT) and conventional therapy (CT). The session consists of 30 minutes a day, 5 days in a week and for total 4 weeks. Performance was measured by FMA-UE, Wolf motor assessment and modified Ash worth scale. The results were the same for both MMT and TMT for upper limb rehabilitation. In 2018 Yumi Ju et al. Conducted study in the Korea to examine the effectiveness of mirror therapy and constrained induced movement therapy for the rehabilitation of the upper extremity for daily life activities. 28 subjects were randomly placed to a weekly session of 5 days and for consecutive 3 weeks. Performance was measured by Manual Function Test (MFT) and Modified Barthel Index(BI) to find the factor which is affecting the activities of daily livings. They concluded that patients actively participate in activities of daily livings by actively moving their affected. Previous researches based on the effectiveness of mirror therapy and constrained induced movement therapy alone or combined with other rehabilitative therapies for improving upper limb rehabilitation in different patients having neurological impairments. Their outcomes were evaluated on different outcome measurement tools and their were significant improvement in patients functional independence and had good quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror therapy | Experimental | Other: Mirror therapySession consist of total 1hour,20 min of passive mobilization, 30 minutes for Movement mirror therapy,10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month. |
| Constrained induced movement therapy (CIMT) | Experimental | Other: CIMT groupSession consist of total 1hour ,20 min of passive mobilization, 30 min session to CIMT and 10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ranges between 40-65 years.
- Chronic stroke (ischemic/hemorrhagic) more than 6 months.
- Ability to participate in a therapy session lasting at least 3 minutes.
- Chronic stroke with mild spasticity (score of 2 or less on Modified Ashworth Scale).
- Good cognitive function (score of 20 or more in Mini Mental state Examination).
Key exclusion criteria (4 listed)
- Patients with orthopedic conditions like fractures, etc.
- Subjects presenting with unable to follow visual command.
- Language deficits that could prevent them from following instructions.
- Age group below 45 years and more than 65 years
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 |
|---|---|---|
| Mirror therapySession consist of total 1hour,20 min of passive mobilization, 30 minutes for Movement mirror therapy,10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month. | Other | Mirror therapy |
| CIMT groupSession consist of total 1hour ,20 min of passive mobilization, 30 min session to CIMT and 10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month. | Other | Constrained induced movement therapy (CIMT) |
Primary outcome
Fugyl Myer assessment tool for upper extremity
Time frame: 3 weeks
The Fugyl Myer assessment (FMA) motor assessments for the upper (maximum score 66 points) and lower extremity (maximum score 34 points) are recommended as core measures to be used in every stroke recovery and rehabilitation trial. Change from baseline FMA at 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Background: PubMed 26180297Park JY, Chang M, Kim KM, Kim HJ. The effect of mirror therapy on upper-extremity function and activities of daily living in stroke patients. J Phys Ther Sci. 2015 Jun;27(6):1681-3. doi: 10.1589/jpts.27.1681. Epub 2015 Jun 30.
- Background: PubMed 30580672Broderick P, Horgan F, Blake C, Ehrensberger M, Simpson D, Monaghan K. Mirror therapy and treadmill training for patients with chronic stroke: a pilot randomized controlled trial. Top Stroke Rehabil. 2019 Apr;26(3):163-172. doi: 10.1080/10749357.2018.1556504. Epub 2018 Dec 22.
- Background: PubMed 26180053Ackerley SJ, Byblow WD, Barber PA, MacDonald H, McIntyre-Robinson A, Stinear CM. Primed Physical Therapy Enhances Recovery of Upper Limb Function in Chronic Stroke Patients. Neurorehabil Neural Repair. 2016 May;30(4):339-48. doi: 10.1177/1545968315595285. Epub 2015 Jul 15.
- Background: PubMed 23192711Teasell R, Mehta S, Pereira S, McIntyre A, Janzen S, Allen L, Lobo L, Viana R. Time to rethink long-term rehabilitation management of stroke patients. Top Stroke Rehabil. 2012 Nov-Dec;19(6):457-62. doi: 10.1310/tsr1906-457.
- Background: PubMed 24926126Lee JS, Lee HG. Effects of sling exercise therapy on trunk muscle activation and balance in chronic hemiplegic patients. J Phys Ther Sci. 2014 May;26(5):655-9. doi: 10.1589/jpts.26.655. Epub 2014 May 29.
- Background: PubMed 25772900Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015 Feb;14(2):224-34. doi: 10.1016/S1474-4422(14)70160-7.
- Background: PubMed 21051765Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
- Background: PubMed 31032717Nasb M, Li Z, S A Youssef A, Dayoub L, Chen H. Comparison of the effects of modified constraint-induced movement therapy and intensive conventional therapy with a botulinum-a toxin injection on upper limb motor function recovery in patients with stroke. Libyan J Med. 2019 Dec;14(1):1609304. doi: 10.1080/19932820.2019.1609304.
- Background: PubMed 31104476Stark A, Farber C, Tetzlaff B, Scherer M, Barzel A. Stroke patients' and non-professional coaches' experiences with home-based constraint-induced movement therapy: a qualitative study. Clin Rehabil. 2019 Sep;33(9):1527-1539. doi: 10.1177/0269215519848813. Epub 2019 May 20.
- 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.
Tehreem Mukhtar, MS 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 Mirror therapy and CIMT group in people with Stroke, 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 6 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: finished, as of the sponsor's last update on 22 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugyl Myer assessment tool for upper extremity (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05053529, which also lists 9 linked publications.
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 22 Sep 2021.