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

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05315089
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
9
Anticipated Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Virtual reality games +conventional exercises
  • Other: Conventional exercises
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Effects and Perception of Intensive Virtual Reality Training on Upper Limb Functions After Stroke
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Fugl- Meyer assessment upper extremity [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

  2. Chedoke Arm and Hand Inventory [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Misbah GhousRawalpindiIslamabadPakistan46000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Misbah Ghous, MSNMPT, Riphah college of Rehabilitation and Allied Health sciences Islamabad

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05315089
Other Study ID Numbers:
  • iqraButt I
First Posted:
Apr 7, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022