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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1
Ehab Abd El Kafy
Mecca, Saudi Arabia, 21955