StrokeNCT05440175
Effects of Combine EMS and Mirror Therapy in Upper Limb Stroke Patients
A study testing EMS, Mirror therapy & exercises, CIMT & exercises and Mirror therapy & exercises in people with Stroke, run by Nouman Khan at 1 site in Pakistan.
Trial summary
This study will be designed to evaluate the effectiveness mirror therapy combined with electrical muscle stimulations compared with constraint induced therapy in upper limb stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- EMS, Mirror therapy & exercises, CIMT & exercises and Mirror therapy & exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Jun 2022to 5 Sep 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female stroke patients above 45 years
- Ischemic and Haemorrhagic chronic stroke patients
- Participants should be able to do 100 wrist extension
Who cannot join
- Patients with an implanted electrical device
- Patients with paresis
- Patients of hemiplegia caused due to other brain injuries (TBI, tumour), Coordination problem
- Individuals with impaired sensory perception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Combined Electrical Muscle Simulator and Mirror Therapy in Upper Limb Stroke Patients
This study will be designed to evaluate the effectiveness mirror therapy combined with electrical muscle stimulations compared with constraint induced therapy in upper limb stroke patients. The aim of the study is to investigate the therapeutic effectiveness of mirror therapy and EMS in stroke patients and compare the outcomes with CIMT.
Read the detailed description
Stroke or CVA is the sudden death of the brain cells due to inadequate blood flow, it's a focal disturbance of cerebral function, with symptoms lasting for 24hrs or longer or leading to death, with no apparent cause other than of vascular origin. The commonest consequence of stroke is loss of upper limb function. The protocol planned for improving the function of the upper limb is mirror therapy combined with EMS and compare with constraint-induced movement therapy (CIMT) treatment in stroke patients Many works done on CIMT and mirror therapy in rehabilitation prove to be powerful tools for upper limbs in people with stroke. Different studies concluded that CIMT is more effective than Mirror Therapy (MT) in the upper extremity in stroke patients. An RCT was published in 2019 in which mirror therapy combined with electrical stimulation proves to be effective in stroke patients. However, I have not found a study comparing EMS combined with Mirror therapy compared to CIMT treatment in stroke patients. According to the Alternate hypothesis mirror therapy combined with EMS has beneficial effects on clinical outcomes in upper limb stroke patients. According to the null hypothesis, CIMT has better results in stroke patients as compared to EMS combined with Mirror therapy.
- Conditions
- Stroke
- Being tested
- EMS, Mirror therapy & exercises, CIMT & exercises, Mirror therapy & exercises
- Keywords
- Electrical muscle stimulation, Constraint induced movement therapy, Mirror therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMS, Mirror therapy & exercisesOther
EMS will be applied with frequency between 20-100 Hz and pulse width between 20 to 450us and Mirror therapy for 30 minutes and four days per week for a total duration of 12 weeks. Exercises include the flexion, extension of the wrist and elbow, ulnar and radial deviations , place any cylindrical object in patients palm and ask to lift the object off the table. other exercises includes external and internal rotations with different task orientations.
CIMT & exercisesOther
Constraint induced movement therapy will be applied for 30 minutes and four days per week for a total duration of 12 weeks, it is a form of rehabilitation therapy that improves upper limb movement, it claims to improve the arm motor ability and the functional use of a paretic arm- hand. Exercises include the flexion, extension of the wrist and elbow, ulnar and radial deviations , place any cylindrical object in patients palm and ask to lift the object off the table. other exercises includes external and internal rotations with different task orientations.
Mirror therapy & exercisesOther
Mirror therapy will be given for 30 minutes and four days per week for a total duration of 12 weeks. The exercises include the flexion, extension of the wrist and elbow, ulnar and radial deviations , place any cylindrical object in patients palm and ask to lift the object off the table. other exercises includes external and internal rotations with different task orientations.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The participants will be given Mirror therapy along with the electrical muscle stimulation and exercises. Receives: Other: EMS, Mirror therapy & exercises |
| Group B | Experimental | The participants will be given constraint induced movement therapy (CIMT) along with exercises. Receives: Other: CIMT & exercises |
| Group C | Experimental | The participants will be given mirror therapy and exercises. Receives: Other: Mirror therapy & exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl- Meyer Assessment
Fugl- Meyer Assessment scale is a stroke specific performance- based impairment index. it has 226 total score and has 5 domains to assess the motor functions, overall reliability of FMA scale was high overall intraclass correlation coefficient varies from 0.61 to 0.97 for the upper extremity and the validity coefficient ranged from 0.91 to 0.97.
Measured: 12 weeks
Secondary outcomes (1)
Motor assessment scale
motor assessment scale is a stroke-specific scale that includes 7 points from 0-6 which includes tone and optimal behavior. A score of 4 on this item indicates a consistently normal response, a score > 4 indicates persistent hypertonus, and a score < 4 indicates various degrees of hypotonus.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start8 Jun 2022
- Primary completion31 Aug 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Model description
- This is an randomized control trail in which the stroke patients are divided into three different treatment group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nouman Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nouman Khan, Shifa Tameer-e-Millat University
- Investigators
- sabahat zahid chaudhary, DPT, Principal investigator, Students
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440175
- Sponsor's protocol ID
- Sabahat IRB #351-21
- Status last verified
- May 2023
- First submitted
- 27 Jun 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee D, Lee G. Effect of afferent electrical stimulation with mirror therapy on motor function, balance, and gait in chronic stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2019 Aug;55(4):442-449. doi: 10.23736/S1973-9087.19.05334-6. Epub 2019 Mar 22.
PubMed 30916531
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Electrical Muscle Simulator and Mirror Therapy in Upper Limb Stroke Patients
- ClinicalTrials.gov ID
- NCT05440175
- Acronym / sponsor ID
- Sabahat IRB #351-21
- Conditions
- Stroke
- Keywords
- Electrical muscle stimulation, Constraint induced movement therapy, Mirror therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nouman KhanUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 30 Jun 2022 (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.
This study will be designed to evaluate the effectiveness mirror therapy combined with electrical muscle stimulations compared with constraint induced therapy in upper limb stroke patients. The aim of the study is to investigate the therapeutic effectiveness of mirror therapy and EMS in stroke patients and compare the outcomes with CIMT.
Detailed description
Stroke or CVA is the sudden death of the brain cells due to inadequate blood flow, it's a focal disturbance of cerebral function, with symptoms lasting for 24hrs or longer or leading to death, with no apparent cause other than of vascular origin. The commonest consequence of stroke is loss of upper limb function. The protocol planned for improving the function of the upper limb is mirror therapy combined with EMS and compare with constraint-induced movement therapy (CIMT) treatment in stroke patients Many works done on CIMT and mirror therapy in rehabilitation prove to be powerful tools for upper limbs in people with stroke. Different studies concluded that CIMT is more effective than Mirror Therapy (MT) in the upper extremity in stroke patients. An RCT was published in 2019 in which mirror therapy combined with electrical stimulation proves to be effective in stroke patients. However, I have not found a study comparing EMS combined with Mirror therapy compared to CIMT treatment in stroke patients. According to the Alternate hypothesis mirror therapy combined with EMS has beneficial effects on clinical outcomes in upper limb stroke patients. According to the null hypothesis, CIMT has better results in stroke patients as compared to EMS combined with Mirror therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is an randomized control trail in which the stroke patients are divided into three different treatment group.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: EMS, Mirror therapy & exercisesThe participants will be given Mirror therapy along with the electrical muscle stimulation and exercises. |
| Group B | Experimental | Other: CIMT & exercisesThe participants will be given constraint induced movement therapy (CIMT) along with exercises. |
| Group C | Experimental | Other: Mirror therapy & exercisesThe participants will be given mirror therapy and exercises. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Both male and female stroke patients above 45 years
- Ischemic and Haemorrhagic chronic stroke patients
- Participants should be able to do 100 wrist extension
Key exclusion criteria (4 listed)
- Patients with an implanted electrical device
- Patients with paresis
- Patients of hemiplegia caused due to other brain injuries (TBI, tumour), Coordination problem
- Individuals with impaired sensory perception
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 |
|---|---|---|
| EMS, Mirror therapy & exercisesEMS will be applied with frequency between 20-100 Hz and pulse width between 20 to 450us and Mirror therapy for 30 minutes and four days per week for a total duration of 12 weeks. Exercises include the flexion, extension of the wrist and elbow, ulnar and radial deviations , place any cylindrical object in patients palm and ask to lift the object off the table. other exercises includes external and internal rotations with different task orientations. | Other | Group A |
| CIMT & exercisesConstraint induced movement therapy will be applied for 30 minutes and four days per week for a total duration of 12 weeks, it is a form of rehabilitation therapy that improves upper limb movement, it claims to improve the arm motor ability and the functional use of a paretic arm- hand. Exercises include the flexion, extension of the wrist and elbow, ulnar and radial deviations , place any cylindrical object in patients palm and ask to lift the object off the table. other exercises includes external and internal rotations with different task orientations. | Other | Group B |
| Mirror therapy & exercisesMirror therapy will be given for 30 minutes and four days per week for a total duration of 12 weeks. The exercises include the flexion, extension of the wrist and elbow, ulnar and radial deviations , place any cylindrical object in patients palm and ask to lift the object off the table. other exercises includes external and internal rotations with different task orientations. | Other | Group C |
Primary outcome
Fugl- Meyer Assessment
Time frame: 12 weeks
Fugl- Meyer Assessment scale is a stroke specific performance- based impairment index. it has 226 total score and has 5 domains to assess the motor functions, overall reliability of FMA scale was high overall intraclass correlation coefficient varies from 0.61 to 0.97 for the upper extremity and the validity coefficient ranged from 0.91 to 0.97.
1 secondary outcome
Motor assessment scale
Time frame: 12 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 10 May 2023.
- Background: PubMed 30916531Lee D, Lee G. Effect of afferent electrical stimulation with mirror therapy on motor function, balance, and gait in chronic stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2019 Aug;55(4):442-449. doi: 10.23736/S1973-9087.19.05334-6. Epub 2019 Mar 22.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
sabahat zahid chaudhary, DPT principal investigator
Students
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMS, Mirror therapy & exercises, CIMT & exercises and Mirror therapy & exercises in people with Stroke, run by Nouman Khan 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 3 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 10 May 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?
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?
Fugl- Meyer Assessment (time frame: 12 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 NCT05440175, which also lists 1 linked publication.
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 10 May 2023.