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

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cross-education
Mirror therapy
Conventional Physical Therapy
Sponsored by
Ahram Canadian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Cross-education training only

Mirror therapy only

Combined cross-education and mirror therapy

Conventional rehabilitation

Arm Description

Participants will perform resistance exercises at 60% of their 1 repetition maximum (1RM) with the less affected limb.

Participants will perform bilateral upper limb movements while observing the reflection of the less affected limb in a mirror.

Participants will perform resistance exercises with the less affected limb while observing its reflection in a mirror.

Participants will receive conventional rehabilitation for post-stroke upper limb motor impairments.

Outcomes

Primary Outcome Measures

Changes in Upper limb strength
Upper limb strength (measured by hand-held dynamometry)
Changes in motor function
motor function (measured by Fugl-Meyer Assessment)

Secondary Outcome Measures

Changes in Quality of life
Quality of life (measured by Stroke Impact Scale)

Full Information

First Posted
June 16, 2023
Last Updated
June 16, 2023
Sponsor
Ahram Canadian University
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1. Study Identification

Unique Protocol Identification Number
NCT05920031
Brief Title
Cross-Education and Mirror Therapy for Upper Limb in Post-Stroke Patients
Official Title
Combining Cross-Education and Mirror Therapy for Upper Limb Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Anticipated)
Primary Completion Date
October 20, 2024 (Anticipated)
Study Completion Date
October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cross-education training only
Arm Type
Experimental
Arm Description
Participants will perform resistance exercises at 60% of their 1 repetition maximum (1RM) with the less affected limb.
Arm Title
Mirror therapy only
Arm Type
Experimental
Arm Description
Participants will perform bilateral upper limb movements while observing the reflection of the less affected limb in a mirror.
Arm Title
Combined cross-education and mirror therapy
Arm Type
Experimental
Arm Description
Participants will perform resistance exercises with the less affected limb while observing its reflection in a mirror.
Arm Title
Conventional rehabilitation
Arm Type
Active Comparator
Arm Description
Participants will receive conventional rehabilitation for post-stroke upper limb motor impairments.
Intervention Type
Other
Intervention Name(s)
Cross-education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Upper limb strength
Description
Upper limb strength (measured by hand-held dynamometry)
Time Frame
Changes in Upper limb strength at baseline, 8 weeks, 16 weeks
Title
Changes in motor function
Description
motor function (measured by Fugl-Meyer Assessment)
Time Frame
Changes in motor function at baseline, 8 weeks, 16 weeks
Secondary Outcome Measure Information:
Title
Changes in Quality of life
Description
Quality of life (measured by Stroke Impact Scale)
Time Frame
Changes in Quality of life at baseline, 8 weeks, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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