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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
EMS, Mirror therapy & exercises
CIMT & exercises
Mirror therapy & exercises
Sponsored by
Nouman Khan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Electrical muscle stimulation, Constraint induced movement therapy, Mirror therapy

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shifa tameer e millat university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

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

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

The participants will be given mirror therapy and exercises.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 27, 2022
Last Updated
May 8, 2023
Sponsor
Nouman Khan
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1. Study Identification

Unique Protocol Identification Number
NCT05440175
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nouman Khan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Electrical muscle stimulation, Constraint induced movement therapy, Mirror therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an randomized control trail in which the stroke patients are divided into three different treatment group.
Masking
Participant
Masking Description
The participant were blinded about the treatment group in which they are enrolled.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
The participants will be given Mirror therapy along with the electrical muscle stimulation and exercises.
Arm Title
Group B
Arm Type
Experimental
Arm Description
The participants will be given constraint induced movement therapy (CIMT) along with exercises.
Arm Title
Group C
Arm Type
Experimental
Arm Description
The participants will be given mirror therapy and exercises.
Intervention Type
Other
Intervention Name(s)
EMS, Mirror therapy & exercises
Intervention Description
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
Intervention Name(s)
CIMT & exercises
Intervention Description
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
Intervention Name(s)
Mirror therapy & exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl- Meyer Assessment
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Motor assessment scale
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sabahat zahid chaudhary, DPT
Organizational Affiliation
Students
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa tameer e millat university
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30916531
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.
Results Reference
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Effects of Combine EMS and Mirror Therapy in Upper Limb Stroke Patients

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