Clinical trial NCT05440175: Effects of Combine EMS and Mirror Therapy in Upper Limb Stroke Patients
Official title: Effects of Combined Electrical Muscle Simulator and Mirror Therapy in Upper Limb Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Electrical muscle stimulation
Constraint induced movement therapy
Mirror therapy
Lead sponsor: Shifa Tameer-e-Millat University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an randomized control trail in which the stroke patients are divided into three different treatment group.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fugl- Meyer Assessment
timeFrame: 12 weeks
Secondary outcomes:
measure: Motor assessment scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shifa tameer e millat university
state: Federal
Study officials:
affiliation: Students
name: sabahat zahid chaudhary, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.