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

NCT04443127 | Unknown DMC

• 1 other identifier: JRizvi
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)

  Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function

  Baseline

• Sensorimotor function of hemiplegic upper extremity (Post-Treatment)

  Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function

  After 4 weeks

• Functional ability of hemiplegic upper extremity (Pre-Treatment)

  Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability

  Baseline

• Functional ability of hemiplegic upper extremity (Post-Treatment)

  Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability

  After 4 weeks

• Cognitive Function (Pre-Treatment)

  Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function

  Baseline

• Cognitive Function (Post-Treatment)

  Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function

  After 4 weeks

Study Arms (2)

Game-Based Rehabilitation

EXPERIMENTAL

Device: Virtual Reality Training Session

Conventional Rehabilitation

PLACEBO COMPARATOR

Behavioral: Motor-Relearning Program

Interventions

Virtual Reality Training Session 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.

Game-Based Rehabilitation

Motor-Relearning Program 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.

Conventional Rehabilitation

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziauddin University: lead

Study Sites (1)

Ziauddin University

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jaza Rizvi

CONTACT

36629251; jaza.rizvi@zu.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invesitgator

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: June 1, 2020
• Primary Completion: August 31, 2020
• Study Completion: October 15, 2020
• Last Updated: June 23, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)