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

NCT ID: NCT05440175

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2022-09-05

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

The participants will be given Mirror therapy along with the electrical muscle stimulation and exercises.

Group Type: EXPERIMENTAL

EMS, Mirror therapy & exercises

Intervention Type: OTHER

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.

Group B

The participants will be given constraint induced movement therapy (CIMT) along with exercises.

Group Type: EXPERIMENTAL

CIMT & exercises

Intervention Type: OTHER

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.

Group C

The participants will be given mirror therapy and exercises.

Group Type: EXPERIMENTAL

Mirror therapy & exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nouman Khan

OTHER

Sponsor Role: lead

Responsible Party

Nouman Khan

lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

sabahat zahid chaudhary, DPT

Role: PRINCIPAL_INVESTIGATOR

Students

Locations

Shifa tameer e millat university

Islamabad, Federal, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 30916531 (View on PubMed)

Other Identifiers

Sabahat IRB #351-21

Identifier Type: -

Identifier Source: org_study_id