Cross-Education and Mirror Therapy for Upper Limb in Post-Stroke Patients

Combining Cross-Education and Mirror Therapy for Upper Limb Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial

This randomized controlled trial will investigate the potential synergistic effects of combining cross-education training with mirror therapy on strength and motor function in the more affected upper limb of post-stroke patients.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Cross-education; Other: Mirror therapy; Other: Conventional Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Post-stroke patients with upper limb motor impairments
• Aged 30 years to 60 years old
• At least 3 months post-stroke
• Able to participate in the intervention

Exclusion Criteria:

• Severe cognitive impairments
• Visual impairments
• Any contraindications to the intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cross-education training only; Participants will perform resistance exercises at 60% of their 1 repetition maximum (1RM) with the less affected limb.	Other: Cross-education; Participants will perform resistance exercises at 60% of their 1 repetition maximum (1RM) with the less affected limb. The intervention will be performed three times per week for 8 weeks. Each session will consist of three sets of 15 repetitions of bicep curls, tricep extensions, and wrist flexion/extension exercises with a 1-minute rest period between sets. The exercises will be performed in a seated position, with the participant's forearm resting on a table and the therapist providing manual resistance. The therapist will be positioned in front of the participant.
Experimental: Mirror therapy only; Participants will perform bilateral upper limb movements while observing the reflection of the less affected limb in a mirror.	Other: Mirror therapy; Participants will perform bilateral upper limb movements while observing the reflection of the less affected limb in a mirror. The intervention will be performed three times per week for 8 weeks. Each session will consist of 10 minutes of mirror therapy, with the participant seated in front of a mirror. The participant will perform various upper limb movements, such as reaching and grasping, while observing the mirror reflection of the less affected limb. The therapist will be positioned beside the participant, providing verbal cues and feedback as necessary.
Experimental: Combined cross-education and mirror therapy; Participants will perform resistance exercises with the less affected limb while observing its reflection in a mirror.	Other: Cross-education; Participants will perform resistance exercises at 60% of their 1 repetition maximum (1RM) with the less affected limb. The intervention will be performed three times per week for 8 weeks. Each session will consist of three sets of 15 repetitions of bicep curls, tricep extensions, and wrist flexion/extension exercises with a 1-minute rest period between sets. The exercises will be performed in a seated position, with the participant's forearm resting on a table and the therapist providing manual resistance. The therapist will be positioned in front of the participant.; Other: Mirror therapy; Participants will perform bilateral upper limb movements while observing the reflection of the less affected limb in a mirror. The intervention will be performed three times per week for 8 weeks. Each session will consist of 10 minutes of mirror therapy, with the participant seated in front of a mirror. The participant will perform various upper limb movements, such as reaching and grasping, while observing the mirror reflection of the less affected limb. The therapist will be positioned beside the participant, providing verbal cues and feedback as necessary.
Active Comparator: Conventional rehabilitation; Participants will receive conventional rehabilitation for post-stroke upper limb motor impairments.	Other: Conventional Physical Therapy; articipants will receive conventional rehabilitation for post-stroke upper limb motor impairments, which may include exercises such as range of motion, stretching, and strengthening of the affected limb, as well as other therapies such as electrical stimulation or constraint-induced movement therapy. The intervention will be individualized for each participant and will be performed three times per week for 8 weeks. The frequency, duration, and intensity of the exercises will be gradually increased over the course of the intervention, based on the participant's progress. The exercises may be performed in a seated or standing position, depending on the participant's ability and preference. The therapist will be positioned in front of or beside the participant, providing verbal cues and feedback as necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Upper limb strength	Upper limb strength (measured by hand-held dynamometry)	Changes in Upper limb strength at baseline, 8 weeks, 16 weeks
Changes in motor function	motor function (measured by Fugl-Meyer Assessment)	Changes in motor function at baseline, 8 weeks, 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Quality of life	Quality of life (measured by Stroke Impact Scale)	Changes in Quality of life at baseline, 8 weeks, 16 weeks

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2023
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 012/0585850002023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No