Effects of Combine EMS and Mirror Therapy in Upper Limb Stroke Patients

Stroke Clinical Trial

Official title:

Effects of Combined Electrical Muscle Simulator and Mirror Therapy in Upper Limb Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05440175
• Other study ID #: Sabahat IRB #351-21
• Status: Completed
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: September 5, 2022

Study information

• Verified date: May 2023
• Source: Shifa Tameer-e-Millat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 5, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Both male and female stroke patients above 45 years
• Ischemic and Haemorrhagic chronic stroke patients
• Participants should be able to do 100 wrist extension

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• EMS, Mirror therapy & exercises
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 & exercises
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 & exercises
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.

Locations

Country	Name	City	State
Pakistan	Shifa tameer e millat university	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Nouman Khan

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	12 weeks