Back to resultsEffects of Virtual Reality Training for Stroke Patients
Primary Purpose
Stroke Patients
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality (VR)
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke Patients focused on measuring Hemiparetic stroke patients, Virtual reality, Impairment upper limbs
Eligibility Criteria
Inclusion Criteria:
- New in-patients clinically diagnosed hemiparetic stroke patients;
- Patients with a history of the first incidence of stroke with upper limb weakness with a motor impairment upper limbs as a primary deficit;
- muscle strength > 2/5 on the Medical Research Council (MRC) scale;
- good cognitive ability as indicated by a score > 15 on the Mini-Mental State Examination (MMSE); Motricity Index sore > 26; and
- ability to communicate and sign the consent.
Exclusion Criteria:
- In-patient with ataxia or any other cerebellar symptoms;
- orthopedic alterations or pain syndrome of the upper limb;
- peripheral nerve damage affecting the upper extremities;
- visual or hearing impairment (does not allow the possibility of interaction with the VR system);
- severe hemispatial neglect;
- severe shoulder or hand pain (unable to volitionally position the hand in the workspace without pain);
- insensate forearm and /or hand, edema of the affected forearm and /or hand;
- uncontrolled seizures disorder;
- severe depression (>13 on beck Depression inventory fast screen); and
- severely impaired cognition or comprehension.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual Reality (VR) Rehabilitation Training
Control - Conventional Rehabilitation Training
Arm Description
Patients in the VR group will receive VR rehabilitation training in the hospital. The content of the training is the same as the control group. The only difference is that participants in the intervention group will use VR as a training platform. The VR system will include the training materials and tasks required for the patients to perform in the 3D environment. Demographic, clinical data and treatment costs will be collected before and after the rehabilitation training.
Patients in the control group will receive conventional rehabilitation training currently provided in the hospital. An instructor will assign each participant for training. Demographic, clinical data, and treatment costs will be collected before and after completing the rehabilitation training
Outcomes
Primary Outcome Measures
The Barthel Index (BI)
To evaluate upper extremity performance motor function of the stroke patients. It consists of 10 self-care activities, including feeding, Bathing, Bowels, Bladder, Toilet Use, Transfer (bed to chair, and back), Mobility (on level surfaces), stairs, etc. with a total score range from 0 to 100, the higher the score, the more independent on their daily activities; It has good validity (0.82) and reliability (0.83).
The Fugl-Meyer Assessment (FMA)
To evaluate the upper limb movements, including the functions on the shoulder, elbow, forearm, wrist, and hand functions of the hemiparetic arm. The FMA is measured on 33 tasks with a 3-point ordinal scale (0 to 2), with a total score range from 0 to 66; the higher the score, the more functioning of the upper limb. It has good validity (0.84) and reliability (0.79).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05178758
Brief Title
Effects of Virtual Reality Training for Stroke Patients
Official Title
Effects of Virtual Reality Training on Upper Extremity Motor Recovery for Stroke Patients: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sultan Qaboos University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine the effects of using a virtual reality (VR) system to improve upper limb motor function among subacute hemiparetic stroke patients. Under this aim, the investigators have two objectives: (1) to develop and test a procedure for the quantitative assessment of stroke patients in a virtual environment; and (2) to compare the outcome measures of the two groups of stroke patients (VR-intervention vs. conventional-control) on these two modes of training.
Detailed Description
After being informed about the study and potential risks, all participants who gave written consent will undergo the study. A randomized controlled trial with pre-/post-study, of 42 stroke patients with upper limb weakness (21 patients in the control group and 21 patients in the intervention group), 18-65 years old, all are newly admitted stroke patients in the rehabilitation clinic from one hospital. Participants in the intervention group will receive 60 minutes of VR training to improve upper limb function and daily living activities. Participants in the control group will receive 60 minutes of conventional training to improve upper limb function and daily living activities. The training includes grasp, grip, pinch, gross, and finger-hand coordination movement. The training will perform 5 times/week for 4 weeks. Two outcome measures: (a) The Barthel Index and (b) The Fugl-Meyer Assessment, time spent to complete a task were used to compare two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Patients
Keywords
Hemiparetic stroke patients, Virtual reality, Impairment upper limbs
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will assess participants' outcomes after they complete the rehabilitation training. The assessor does not know who is undergoing the VR (intervention) or non-VR (control) rehabilitation training
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality (VR) Rehabilitation Training
Arm Type
Experimental
Arm Description
Patients in the VR group will receive VR rehabilitation training in the hospital. The content of the training is the same as the control group. The only difference is that participants in the intervention group will use VR as a training platform. The VR system will include the training materials and tasks required for the patients to perform in the 3D environment. Demographic, clinical data and treatment costs will be collected before and after the rehabilitation training.
Arm Title
Control - Conventional Rehabilitation Training
Arm Type
No Intervention
Arm Description
Patients in the control group will receive conventional rehabilitation training currently provided in the hospital. An instructor will assign each participant for training. Demographic, clinical data, and treatment costs will be collected before and after completing the rehabilitation training
Intervention Type
Device
Intervention Name(s)
Virtual Reality (VR)
Intervention Description
Patients in the intervention (VR) group will receive a series of occupational and physical therapy rehabilitation training using the VR system. All training is consists of daily activities oriented by an occupational therapist, including grasp, grip, pinch, gross, and finger-hand coordination movement. Each training will take around 1 hour for one session per day 5 times per week over a maximum of 4 weeks. The training presented a one-on-one that allowed interaction between instructor (or VR system) and participant.
Primary Outcome Measure Information:
Title
The Barthel Index (BI)
Description
To evaluate upper extremity performance motor function of the stroke patients. It consists of 10 self-care activities, including feeding, Bathing, Bowels, Bladder, Toilet Use, Transfer (bed to chair, and back), Mobility (on level surfaces), stairs, etc. with a total score range from 0 to 100, the higher the score, the more independent on their daily activities; It has good validity (0.82) and reliability (0.83).
Time Frame
Change from baseline scores on the Barthel index after 4 weeks training
Title
The Fugl-Meyer Assessment (FMA)
Description
To evaluate the upper limb movements, including the functions on the shoulder, elbow, forearm, wrist, and hand functions of the hemiparetic arm. The FMA is measured on 33 tasks with a 3-point ordinal scale (0 to 2), with a total score range from 0 to 66; the higher the score, the more functioning of the upper limb. It has good validity (0.84) and reliability (0.79).
Time Frame
Change from baseline scores on the Fugl-Meyer Assessment after 4 weeks training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
New in-patients clinically diagnosed hemiparetic stroke patients;
Patients with a history of the first incidence of stroke with upper limb weakness with a motor impairment upper limbs as a primary deficit;
muscle strength > 2/5 on the Medical Research Council (MRC) scale;
good cognitive ability as indicated by a score > 15 on the Mini-Mental State Examination (MMSE); Motricity Index sore > 26; and
ability to communicate and sign the consent.
Exclusion Criteria:
In-patient with ataxia or any other cerebellar symptoms;
orthopedic alterations or pain syndrome of the upper limb;
peripheral nerve damage affecting the upper extremities;
visual or hearing impairment (does not allow the possibility of interaction with the VR system);
severe hemispatial neglect;
severe shoulder or hand pain (unable to volitionally position the hand in the workspace without pain);
insensate forearm and /or hand, edema of the affected forearm and /or hand;
uncontrolled seizures disorder;
severe depression (>13 on beck Depression inventory fast screen); and
severely impaired cognition or comprehension.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moon Fai Chan
Phone
+968 24141132
Email
moonf@squ.edu.om
First Name & Middle Initial & Last Name or Official Title & Degree
Hamdan Al Habsi
Phone
+968 24141128
Email
habsi@squ.edu.om
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moon Fai Chan
Organizational Affiliation
Sultan Qaboos University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Virtual Reality Training for Stroke Patients
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