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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05920031
Other study ID # 012/0585850002023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 28, 2023
Est. completion date October 20, 2024

Study information

Verified date June 2023
Source Ahram Canadian University
Contact Mohamed M ElMeligie, Ph.d
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 20, 2024
Est. primary completion date October 20, 2024
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Upper limb strength Upper limb strength (measured by hand-held dynamometry) Changes in Upper limb strength at baseline, 8 weeks, 16 weeks
Primary Changes in motor function motor function (measured by Fugl-Meyer Assessment) Changes in motor function at baseline, 8 weeks, 16 weeks
Secondary Changes in Quality of life Quality of life (measured by Stroke Impact Scale) Changes in Quality of life at baseline, 8 weeks, 16 weeks
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