Effects and Perception of Intensive Virtual Reality Training on Upper Limb Functions After Stroke

May 10, 2022 updated by: Riphah International University
Previous literature review shows limited work on upper limb recovery from Virtual Reality device and most of them are pilot studies meta-analysis some Randomized control Trial studies are done but this study will cover mixed method including both qualitative and quantitative method.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is the leading cause of disability worldwide Approximately 80% of stroke survivors regain ability to walk, 30 - 66% of survivors are not able to use their affected upper limb mobility. With improving survival rates and longer life expectancy in general, the burden of caring for stroke survivors is likely to increase. As a lack of upper limb recovery results in significant dependence and a reduced quality of life. Persistent upper limb (UL) dysfunction after a stroke is one of the most challenging issues in rehabilitation. Effective upper limb treatment interventions have therefore been identified as a priority for stroke research. One of the rehabilitation strategies include performing self-administered exercises using VR games technology. Effective treatment interventions post-stroke is characterized by high intensity and repetitive practice of a meaningful task. However, changes in infrastructure, an emphasis on mobility during early rehabilitation ,to reduce hospital length of stay and a lack of therapy on discharge home have resulted in challenges delivering the amount of rehabilitation necessary to optimize recovery. A promising technique, which has the capability of creating an interactive environment in which practice intensity and feedback can be manipulated to retrain movement in the upper limb in people with stroke, is virtual reality (VR) technology .VR provides a sense of illusion: of being immersed in a world where objects can he visualized and interact with. The system is usually a controlled one, where the objects and interaction styles (point, touch, grasp) are defined prior to the controlling program being executed. There are a number of ways in which the virtual environment (VE) can he presented to the user. Most common are desktop (fish tank) VR systems where the VE is displayed on a standard desktop monitor. The user can interact with the environment via standard hardware (keyboard, mouse) or via specialized VR devices such as data gloves, hut is conscious of 'looking at' the environment rather than 'immersed in' the environment.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

1- Subacute and chronic stroke patient > 3 months post stroke till 1 year. 2. Both gender 3. Age: 40-70 years 4. Modified Ashworth scale1-3 5. MMSE>25 6. Able to follow verbal instructions related to the use of VR devices

Exclusion Criteria:

  1. Neurological disorders other than stroke.
  2. Aphasia that would limit the ability to follow verbal instructions.
  3. Participation in other upper extremity therapies during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Interventional Group
Virtual reality games +conventional exercises
Other: Virtual reality games +conventional exercises
Virtual reality games +conventional exercises
ACTIVE_COMPARATOR: control Group
Conventional exercises
Other: Conventional exercises
Conventional exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl- Meyer assessment upper extremity
Time Frame: Change from Baseline , motor functions to 3 Week, to 6 week
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia
Change from Baseline , motor functions to 3 Week, to 6 week
Chedoke Arm and Hand Inventory
Time Frame: Change from Baseline , motor functions of hand to 3 Week, to 6 week
The Chedoke Arm and Hand Activity Inventory (CAHAI) is a functional assessment of the recovering arm and hand after stroke
Change from Baseline , motor functions of hand to 3 Week, to 6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2022

Primary Completion (ANTICIPATED)

December 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (ACTUAL)

April 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/01245 Iqra Butt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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