Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04764994
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2021-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality-based Training Program on Improving Upper-Limb Functions in Participants With Stroke.
Sponsor:
Umm Al-Qura University
Organization:
Study Overview
Official Title:
Using of Virtual Reality Technology for Improving Upper-limb Functions in Saudi Patients With Stroke: A Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: