Status:

COMPLETED

The Effect of Virtual Reality-based Training Program on Improving Upper-Limb Functions in Participants With Stroke.

Lead Sponsor:

Umm Al-Qura University

Conditions:

Stroke

Eligibility:

All Genders

50-60 years

Phase:

NA

Brief Summary

Stroke is the third commonest cause of death and is probably the commonest cause of severe disability. Upper limb recovery after stroke is unacceptably poor with only 50% of stroke survivors likely to...

Detailed Description

This research project will achieve its objectives and outcomes in five phases: There are 5 phases for this research work: (1) preparation phase, (2) Therapeutic intervention phase, (3) Evaluation pha...

Eligibility Criteria

Inclusion

  • Forty Saudi stroke male participants will be included in this study.
  • The participating participants will have a confirmed diagnosis of stroke confirmed by magnetic resonance images (MRIs) obtained from medical records or personal physicians.
  • They should be medically stable and will have neither serious nor recurring medical complications according to the medical report signed by their physician.
  • The age of participants will be between 50 to 60 years.
  • Participants of both genders will be recruited
  • The participants will be selected to be in spastic phase, 6-24 months following a first stroke.
  • The degree of spasticity in upper extremity according to Modified Ashworth Scale will ranged between grades 1,1+\&2.
  • The included participants should be cognitively competent and able to understand and follow instructions.
  • The participants will associated with neither fixed stiffness in shoulder, elbow, wrist and fingers joints nor major rotational mal-alignments in the upper limbs.
  • The patient should have the ability to extend the wrist at least 20° and fingers 10° from full flexion. This range will allow participants to engage easily in performing a designed program.
  • Also they should have no serious problems affecting balance performance other than spasticity due to stroke.
  • During the study, participants will not receive any treatment to improve involved upper limb functions other than the study intervention.

Exclusion

  • Participants will be excluded from study if they have:
  • Cognitive decline (Mini-Mental State Examination \< 23 points). Due to the requirements of the ARMEO system.
  • Shoulder pain on a visual analogue scale of \> 6/10.
  • Spasticity score ≥ 2 according to the Modified Ashworth Scale
  • Conditions affecting their participations in this study (e.g. cardiac, respiratory, seizures or arthritic problems)
  • Visual problems that may prevent them from performing the intervention
  • Botulinum toxin in the upper extremity musculature six months before baseline assessment or who wished to receive it within the period of study,
  • Muscle-tone control medications before baseline assessment or who wished to receive it within the period of study.
  • A cardiac pacemaker as the electromagnetic motion tracker used within the virtual reality system might interfere with such devices.

Key Trial Info

Start Date :

February 18 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 15 2021

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT04764994

Start Date

February 18 2021

End Date

August 15 2021

Last Update

November 8 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Ehab Abd El Kafy

Mecca, Saudi Arabia, 21955