Clinical trial NCT04764994: The Effect of Virtual Reality-based Training Program on Improving Upper-Limb Functions in Participants With Stroke.
Official title: Using of Virtual Reality Technology for Improving Upper-limb Functions in Saudi Patients With Stroke: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hemiplegia
Virtual-Reality
Upper Limb Functions
Balance Performance
Lead sponsor: Umm Al-Qura University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 regain some functional use. In many disabilities, the rehabilitation process is of long duration and clinicians face the challenge of identifying a variety of meaningful and motivating intervention tasks that may be adapted and graded to facilitate this process.. Motor learning models emphasize that self-generated voluntary actions should be used and repeated in playful and motivational settings and that the difficulties of the task have to be at an appropriate level for successful learning. Motivation to use the hemiplegic upper extremity was considered to be the most important factor in guaranteeing intense practice and was achieved through the patient's individual inner drive and motivation for play. Virtual reality-based therapy is one of the most innovative and developments in rehabilitation technology. Enhanced feedback provided by a virtual reality system has been shown to promote motor learning in normal subjects. Interaction with objects in a virtual environment (VE) through grasping and manipulation is an important feature of future virtual reality simulations. Until now, there has been limited research involving the inclusion of virtual reality gaming systems in neuro-rehabilitation for hemiplegic patients. So the purpose of this study will be evaluation of the efficacy of virtual reality technology on improving the function of the involved upper extremity in Saudi patients having stroke.

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 phase, (4) Phase of data and statistical analyses, (5) The phase of Result Publication Phase.

Phase (1): Preparation phase.

This phase have been undertaken to set up and identify the inclusion and exclusion criteria of participant patients, determination of the sample size and randomization procedure for this study, purchasing the instruments that will be used in the study.

1.1 Setting up participant criteria. (This phase has completed) 1.2 Determination of the sample size and randomization procedure. Sample size: 40 patients will participated in this study. They will divided randomly to equal groups.

Randomization: (Not yet recruiting) In order to eliminate bias in treatment, randomization will be established for the patients who will be included in both experimental group A \& control group B. It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance. Evaluation of the patients with stroke will be performed by evaluators who will not participated in application of intervention and the therapists will be blinded from the randomization and blinding process. Simple randomization using a randomization table created by computer software (i.e. computerized sequence generation)

1.3 Purchasing the instruments. (This phase has completed) The following device has been already purchased: Armeo Functional upper extremity rehabilitation (MRF; Hocoma, Switzerland). (For treatment)

* Other evaluation instruments that will be used in this study are available in the University Research Labs

Phase (2): Therapeutic intervention phase. (This phase has not yet started)

Therapeutic intervention will be carried out three sessions per week for twelve successive weeks for both experimental and control groups. The treatment session will continue 2 hours with 15 minute rest between the first and the second hours. (More details are explained in the intervention section)

Phase (3): Evaluation phase. (This phase has not yet started)

The evaluation phase include the examination of the study predetermined parameters at both baseline, and 12 weeks after intervention commencement

Phase (4): Data and Statistical Analysis phase. This phase will start after all participants who will recruited for this study will be examined for the purposes of final collection of out-come data.

The statistical analysis will include:

The differences in demographics (such as age, height and weight) between study/experimental and control groups before treatment will be examined using one-way ANOVA.

Paired t test will be used to identify the mean differences in outcome measures within groups to compare the means of primary and secondary outcome measures between pre-treatment and post-treatment for each group.

One-way ANOVA with post-hoc tests will be used to identify the mean differences in primary and secondary outcome measures between study/experimental and control groups.

Phase (5): Result Publication Phase. This phase will start after all participants who will recruited for this study will be examined for the purposes of final collection of out-come data

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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.

Primary outcomes:
measure: Change in the score of Fugl-Meyer Assessment Scale of Upper-Extremity (scale that assess the change in upper extremity motor functions)
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between Fugl-Meyer Assessment Scale Score of Upper-Extremity at both baseline and completion of 12 weeks of intervention)
measure: Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 12 weeks of intervention)
measure: Change in the score of The Wolf Motor Function Test (test that assess the change in upper extremity motor ability)
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between The Wolf Motor Function Test Score at both baseline and completion of 12 weeks of intervention)
Secondary outcomes:
measure: Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assess the change in postural stability)
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall stability indices score at both baseline and completion of 12 weeks of intervention)
measure: Change in the Overall Stability Index {percentage value (%)}, and Time of Control {seconds} for Limit of Stability Test (test that assess the change in balance ability)
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall stability index and the time of control at both baseline and completion of 12 weeks of intervention)
measure: Change in the cadence (step/minute) (which indicate the change of walking ability in patients with stroke).
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between cadence at both baseline and completion of 12 weeks of intervention)
measure: Change in the Gait Velocity (meter /second) (which indicate the change of gait function in patients with stroke).
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between gait velocity at both baseline and completion of 12 weeks of intervention)
measure: Change in the Hand Grip Strength of the Involved Upper Extremity (pounds) (which indicate the change of the strength of the involved hand muscles in patients with stroke).
timeFrame: [Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between hand grip strength at both baseline and completion of 12 weeks of intervention)
Other outcomes:
Locations:
city: Mecca
country: Saudi Arabia
facility: Ehab Abd El Kafy
Study officials:
affiliation: Professor of Physical Therapy -Umm Al Qura University.
name: Ehab Abd El Kafy, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: