NCT06459570

Brief Summary

this thesis endeavors to shed light on the efficacy of VR-based sword-fighting exercises as a rehabilitation tool for improving upper body movement in hemiplegic patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

October 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

June 14, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 10, 2024

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment of upper limb (FMA)

    This measures upper limb impairment and scores from 0 to 66, the higher the score, the less the impairment. 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.

    12 Months

  • Action Research Arm Test (ARAT)

    This measures arm and hand function and ranges from 0 to 57, the higher the score, the better the upper limb function. The ARAT is a 19-item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point

    12 months

Study Arms (2)

Virtual reality based exercises

EXPERIMENTAL
Behavioral: Virtual reality based exercises

standard physical therapy

OTHER
Other: standard physical therapy

Interventions

one experimental group with Virtual reality-based exercises. Subjects in the VR-based exercises will receive 12 sessions of the VR-based exercises treatment, administered four times a week over 3 weeks, with each session lasting approximately 60 minutes.

Virtual reality based exercises

"Second control group with standard physical therapy and occupational therapy treatment.Subjects in the control group will receive 12 sessions of physical therapy treatment involving passive and active range of motion exercises, muscle strengthening, and therapeutic stretching, administered four times a week over a span of 3 weeks, with each session lasting approximately 60 minutes.

standard physical therapy

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21-80 years
  • First clinical stroke, ischemic or hemorrhagic, with diagnosis of stroke confirmed on CT/MRI brain scan.
  • Less than 6 weeks after stroke onset
  • Upper limb weakness of Medical Research Council (MRC) motor power of grade 2-4 motor power in either the shoulder, elbow or the fingers of the hemiplegic upper extremity
  • Subject can understand simple instructions and learn

You may not qualify if:

  • Recurrent stroke
  • History of epilepsy
  • Presence of arthritis or pain in the affected upper limb restricting repetitive exercises
  • Severe aphasia or cognitive impairment, or other psychiatric illnesses that limit the ability to participate or give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 14, 2024

Study Start

October 1, 2023

Primary Completion

May 1, 2024

Study Completion

September 30, 2024

Last Updated

June 14, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations