Effects of Virtual Reality Training for Stroke Patients

Stroke Patients Clinical Trial

Official title:

Effects of Virtual Reality Training on Upper Extremity Motor Recovery for Stroke Patients: A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05178758
• Other study ID #: MREC #2593
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2022
• Source: Sultan Qaboos University
• Contact: Moon Fai Chan
• Phone: +968 24141132
• Email: moonf[@]squ.edu.om
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: September 30, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. New in-patients clinically diagnosed hemiparetic stroke patients;

2. Patients with a history of the first incidence of stroke with upper limb weakness with a motor impairment upper limbs as a primary deficit;

3. muscle strength > 2/5 on the Medical Research Council (MRC) scale;

4. good cognitive ability as indicated by a score > 15 on the Mini-Mental State Examination (MMSE); Motricity Index sore > 26; and

5. ability to communicate and sign the consent.

Exclusion Criteria:

1. In-patient with ataxia or any other cerebellar symptoms;

2. orthopedic alterations or pain syndrome of the upper limb;

3. peripheral nerve damage affecting the upper extremities;

4. visual or hearing impairment (does not allow the possibility of interaction with the VR system);

5. severe hemispatial neglect;

6. severe shoulder or hand pain (unable to volitionally position the hand in the workspace without pain);

7. insensate forearm and /or hand, edema of the affected forearm and /or hand;

8. uncontrolled seizures disorder;

9. severe depression (>13 on beck Depression inventory fast screen); and

10. severely impaired cognition or comprehension.

Related Conditions & MeSH terms

• Stroke
• Stroke Patients

Intervention

Device:
• Virtual Reality (VR)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Qaboos University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline scores on the Barthel index after 4 weeks training
Primary	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).	Change from baseline scores on the Fugl-Meyer Assessment after 4 weeks training