NCT05673421

Brief Summary

Stroke is classically characterized as a neurological deficit attributed to an acute focal injury of the central nervous system (CNS) by a vascular cause, including transient ischemic attack, cerebral infarction, intracerebral hemorrhage, and subarachnoid hemorrhage. It is a major cause of disability and death worldwide. The main purpose of this study to determine the effect of exergaming training compared to visual feedback training on improvement in upper limb function.

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 Jan 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

January 4, 2023

Last Update Submit

February 23, 2023

Conditions

Keywords

upper limb functions

Outcome Measures

Primary Outcomes (3)

  • Fugyl Meyer Assessment scale

    It is now widely used for clinical assessment of motor function. This is an impairment-based test with items organized by sequential recovery stages. Change from baseline and 2 months

    2 months

  • Box and block test

    The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. Change from baseline and 2 months

    2 months

  • wolf motor function test

    The Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks. Change from baseline and 2 months

    2 months

Study Arms (2)

Exergaming Training Group

EXPERIMENTAL

VR game-assisted intervention will perform for 30-45 min, 5 sessions per week for a duration of 8 weeks.

Other: Exergaming Training

Visual Feedback Training

ACTIVE COMPARATOR

During the visual feedback practices, patients will be seated or in a standing phase close to a table on which a mirror would be placed vertically. The practice would be consisted of nonparetic-side shoulder, elbow, wrist and finger flexion, extension, abduction, adduction movements, task oriented activities like, unscrewing lid of jar ,card stacking, moving coins or marbles from one box to another, Folding towels and stacking them, picking glass, while patient will look into the mirror, -watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. After watching the practices on the uninvolved side, patient will be asked to try to do the same movements with the paretic limb while they will be moving the nonparetic limb. Each activity will be performed for 4 min, with a 1 min preparation time between tasks.

Other: Visual Feedback Training

Interventions

VR game-assisted intervention will perform for 30-45 min, 5 sessions per week for a duration of 8 weeks

Exergaming Training Group

During the visual feedback practices, patients will be seated or in a standing phase close to a table on which a mirror would be placed vertically. The practice would be consisted of nonparetic-side shoulder, elbow, wrist and finger flexion, extension, abduction, adduction movements, task oriented activities like, unscrewing lid of jar ,card stacking, moving coins or marbles from one box to another, Folding towels and stacking them, picking glass, while patient will look into the mirror, -watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. After watching the practices on the uninvolved side, patient will be asked to try to do the same movements with the paretic limb while they will be moving the nonparetic limb.Each activity will be performed for 4 min, with a 1 min preparation time between tasks.

Visual Feedback Training

Eligibility Criteria

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

You may qualify if:

  • Both genders
  • Subacute and chronic patients of stroke (\> 4 weeks).
  • Age: 40-70 years
  • Able to follow verbal instructions related to the visual feedback training.
  • MMSE score \>21
  • Modified Ashworth scale (MAS) level 1-3
  • Brunnstrom stages 1-4
  • Fugyl Meyer score limit for upper limb

You may not qualify if:

  • Patients with
  • Cognitive and Visual impairments
  • Psychological disorder
  • History of other neurological disorders
  • Pusher's syndrome
  • Hemineglect
  • Abnormal synergic pattern
  • Rheumatoid arthritis or other hand impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafsa

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Misbah Ghous, MSNMPT

    Riphah International University islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Misbah Ghous, MSNMPT

CONTACT

Hafsah Rashid, MS*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Visual Feedback Training Group
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Exergaming training
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 6, 2023

Study Start

January 10, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 27, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations