Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients

NCT ID: NCT04443127

Last Updated: 2020-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-10-15

Brief Summary

Stroke is the second leading global cause of mortality counting for 6.5 million deaths per annum. The global prevalence of stroke is increasing with an estimated prevalence of 33 million per year, affecting 1 out of 6 individuals during their lifetime. The international data suggests the overall economic burden in Asia is projected to be increased to 1.3 Billion by 2050. Therefore, the appropriate and timely stroke intervention is required to save healthcare costs and reduce the burden of the disease. Studies have reported the effectiveness of VR intervention not only in cognitive abilities but it has found to be simultaneously effective in improving other domains as attention and coordination with motor retraining. VR combined with a newly developed concept of motor priming has shown encouraging results in improving motor control and task execution in stroke patients. Further studies are needed to analyze the impact of motor priming with VR in stroke patients on varied neurological domains; hence the present study aims to investigate the impact of VR based motor priming on sensorimotor, functional and cognitive outcomes among sub-acute stroke patients rehabilitation.

Detailed Description

A total 62 patients will be recruited in the study. After voluntary consent, all the patients will be randomly divided into Group-A and B through the envelope method of simple random sampling. Patients in Group-A will be receiving VR based motor priming intervention while Group-B patients will be receiving Motor-Relearning Program as conventional therapy. Whereas, both the groups will be given 16 sessions of their respective protocol, comprising of 45 minutes, 4 times/week for the duration of 4 weeks. Pre and post assessment will be performed for each patient on all three quantitative outcome measures i.e. FMA-UE, CAHAI-13, and MoCA. A trial will be terminated, if the patient reported fatigue of >8 out of 10 on the Visual Analogue Scale, unable to execute movements, reports pain, eye strain, or signs of volitional fatigue in hemiplegic or non-hemiplegic extremities.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Game-Based Rehabilitation

Group Type: EXPERIMENTAL

Virtual Reality Training Session

Intervention Type: DEVICE

VR based motor priming intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.

Conventional Rehabilitation

Group Type: PLACEBO_COMPARATOR

Motor-Relearning Program

Intervention Type: BEHAVIORAL

Motor-Relearning Program intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.

Interventions

Virtual Reality Training Session

VR based motor priming intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.

Intervention Type: DEVICE

Motor-Relearning Program

Motor-Relearning Program intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male and female stroke patients aged 25-65 years
• Patients who had an ischemic or hemorrhagic stroke in sub-acute phase of < 3 months
• Mild cognitive impairment i.e. < 26 (19.0-25.2) on MoCA
• Minimum Scoring of 28 in the Motricity Index

Exclusion Criteria

• Diagnosed visual-perceptual ailments which may restrict task execution
• Communication disorders such as aphasia or dysarthria which may impede cognitive assessment
• Comorbidities such as elevated blood pressure (>160mmhg/105 mmHg), heart diseases or chronic medical conditions
• Major or active psychological illness and pre-existing dementia

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziauddin University

OTHER

Sponsor Role: lead

Responsible Party

Jaza Rizvi

Principal Invesitgator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziauddin University

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Jaza Rizvi

Role: CONTACT

jaza.rizvi@zu.edu.pk

36629251 ext. 5

Facility Contacts

Jaza Rizvi

Role: primary

jaza.rizvi@zu.edu.pk

36629251 ext. 5

Other Identifiers

JRizvi

Identifier Type: -

Identifier Source: org_study_id