NCT05920031

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

1.3 years

First QC Date

June 16, 2023

Last Update Submit

June 16, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Changes in Quality of life

    Changes in Quality of life at baseline, 8 weeks, 16 weeks

Study Arms (4)

Cross-education training only

EXPERIMENTAL

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

Other: Cross-education

Mirror therapy only

EXPERIMENTAL

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

Other: Mirror therapy

Combined cross-education and mirror therapy

EXPERIMENTAL

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

Other: Cross-educationOther: Mirror therapy

Conventional rehabilitation

ACTIVE COMPARATOR

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

Other: Conventional Physical Therapy

Interventions

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.

Combined cross-education and mirror therapyCross-education training only

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.

Combined cross-education and mirror therapyMirror therapy only

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.

Conventional rehabilitation

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Amal Fawzy, Ph.d

    Faculty of Physical Therapy, Ahram Canadian University

    STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

First Submitted

June 16, 2023

First Posted

June 27, 2023

Study Start

June 28, 2023

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations