NCT05315089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

March 30, 2022

Last Update Submit

May 10, 2022

Conditions

Stroke

Keywords

intensive virtual realityupper limb functions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Interventional Group

EXPERIMENTAL

Virtual reality games +conventional exercises

Other: Virtual reality games +conventional exercises

control Group

ACTIVE COMPARATOR

Conventional exercises

Other: Conventional exercises

Interventions

Virtual reality games +conventional exercisesOTHER

Virtual reality games +conventional exercises

Interventional Group
Conventional exercisesOTHER

Conventional exercises

control Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misbah Ghous

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

Related Publications (4)

  • 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.

    PMID: 24620739BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 29764799BACKGROUND

  • 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.

    PMID: 24681826BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Misbah Ghous, MSNMPT

    Riphah college of Rehabilitation and Allied Health sciences Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2022

First Posted

April 7, 2022

Study Start

April 1, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)