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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315089
• Other study ID #: REC/01245 Iqra Butt
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2022
• Source: Riphah International University
• Contact: Imran Amjad, PHD
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Virtual reality games +conventional exercises
Virtual reality games +conventional exercises
• Conventional exercises
Conventional exercises

Locations

Country	Name	City	State
Pakistan	Misbah Ghous	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Elnady A, Mortenson WB, Menon C. Perceptions of Existing Wearable Robotic Devices for Upper Extremity and Suggestions for Their Development: Findings From Therapists and People With Stroke. JMIR Rehabil Assist Technol. 2018 May 15;5(1):e12. doi: 10.2196/rehab.9535. — View Citation

Hughes AM, Burridge JH, Demain SH, Ellis-Hill C, Meagher C, Tedesco-Triccas L, Turk R, Swain I. Translation of evidence-based Assistive Technologies into stroke rehabilitation: users' perceptions of the barriers and opportunities. BMC Health Serv Res. 2014 Mar 12;14:124. doi: 10.1186/1472-6963-14-124. — View Citation

Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014. — View Citation

Ward N, Kelly K, Brander F. The future of stroke rehabilitation: upper limb recovery. ACNR. 2015;15(4):6-8.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl- Meyer assessment upper extremity	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
Primary	Chedoke Arm and Hand Inventory	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