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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Virtual Reality Training Session
Motor-Relearning Program
Sponsored by
Ziauddin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziauddin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Game-Based Rehabilitation

Conventional Rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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
Cognitive Function (Pre-Treatment)
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
Cognitive Function (Post-Treatment)
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function

Secondary Outcome Measures

Full Information

First Posted
June 20, 2020
Last Updated
June 20, 2020
Sponsor
Ziauddin University
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1. Study Identification

Unique Protocol Identification Number
NCT04443127
Brief Title
Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients
Official Title
Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
October 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Game-Based Rehabilitation
Arm Type
Experimental
Arm Title
Conventional Rehabilitation
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Virtual Reality Training Session
Intervention Description
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
Behavioral
Intervention Name(s)
Motor-Relearning Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)
Description
Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
Time Frame
Baseline
Title
Sensorimotor function of hemiplegic upper extremity (Post-Treatment)
Description
Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function
Time Frame
After 4 weeks
Title
Functional ability of hemiplegic upper extremity (Pre-Treatment)
Description
Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
Time Frame
Baseline
Title
Functional ability of hemiplegic upper extremity (Post-Treatment)
Description
Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability
Time Frame
After 4 weeks
Title
Cognitive Function (Pre-Treatment)
Description
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
Time Frame
Baseline
Title
Cognitive Function (Post-Treatment)
Description
Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function
Time Frame
After 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaza Rizvi
Phone
36629251
Ext
5
Email
jaza.rizvi@zu.edu.pk
Facility Information:
Facility Name
Ziauddin University
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaza Rizvi
Phone
36629251
Ext
5
Email
jaza.rizvi@zu.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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