NCT05440175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2022

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

June 27, 2022

Last Update Submit

May 8, 2023

Conditions

Keywords

Electrical muscle stimulationConstraint induced movement therapyMirror therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Motor assessment scale

    12 weeks

Study Arms (3)

Group A

EXPERIMENTAL

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

Other: EMS, Mirror therapy & exercises

Group B

EXPERIMENTAL

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

Other: CIMT & exercises

Group C

EXPERIMENTAL

The participants will be given mirror therapy and exercises.

Other: Mirror therapy & exercises

Interventions

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 A

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 B

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.

Group C

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa tameer e millat university

Islamabad, Federal, 44000, Pakistan

Location

Related 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.

    PMID: 30916531BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement TherapyExercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeuticsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • sabahat zahid chaudhary, DPT

    Students

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant were blinded about the treatment group in which they are enrolled.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is an randomized control trail in which the stroke patients are divided into three different treatment group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 27, 2022

First Posted

June 30, 2022

Study Start

June 8, 2022

Primary Completion

August 31, 2022

Study Completion

September 5, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations