Effects of Virtual Reality Training for Stroke Patients

NCT05178758 | Unknown

• 1 other identifier: MREC #2593
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke Patients

Keywords

Hemiparetic stroke patients; Virtual reality; Impairment upper limbs

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Virtual Reality (VR) Rehabilitation Training

EXPERIMENTAL

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.

Device: Virtual Reality (VR)

Control - Conventional Rehabilitation Training

NO INTERVENTION

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

Interventions

Virtual Reality (VR) DEVICE

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.

Virtual Reality (VR) Rehabilitation Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Officials

• Moon Fai Chan

  Sultan Qaboos University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moon Fai Chan

CONTACT

+968 24141132; moonf@squ.edu.om

Hamdan Al Habsi

CONTACT

+968 24141128; habsi@squ.edu.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 5, 2022
• Study Start: June 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share