NCT06582394

Brief Summary

In hemiparetic stroke patient's VR is very useful. Due to hemiparesis one side muscle weakness occurs because of disruption in brain, spinal cord and nervous system technologies improvs motor activities of patients, by improvement in motor activities patients perform activities in better way.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

August 21, 2024

Last Update Submit

August 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Barthel index

    The Barthel Index is a scale used to measure a person's ability to perform basic activities of daily living (ADL) independently. It assesses 10 areas of functioning, with a focus on mobility and self-care. Scores range from 0 to 100, with higher scores indicating greater independence. Stroke-Specific Quality of Life Scale (SS-QOL) It assesses the impact of stroke on the quality of life across various domains, including physical, emotional, social, and cognitive aspects. It uses 12 domains with items scored on a 5-point Likert scale

    12 Months

Study Arms (2)

Exp Group

EXPERIMENTAL
Combination Product: Exp Group

Control Group

ACTIVE COMPARATOR
Other: Control group

Interventions

Exp GroupCOMBINATION_PRODUCT

Balance and coordination were targeted through virtual stepping tasks, where participants practiced stepping in various directions to improve postural control and lower limb function. Additionally, they performed virtual balance exercises by standing on simulated platforms of varying stability. For gait and mobility, participants practiced walking in a virtual environment with real-time feedback to correct gait abnormalities. They also encountered virtual obstacles, which required them to adapt their walking patterns and improve mobility. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes.

Exp Group

For gait training, participants practiced walking on flat surfaces, sometimes with the assistance of parallel bars or walking aids, to improve their walking speed, step length, and rhythm. They also performed sit-to-stand exercises to strengthen the lower limbs and improve mobility for daily activities. Additionally, manual therapy techniques, such as joint mobilizations and stretching, were applied to reduce spasticity and increase range of motion in the affected limbs. Both treatment groups progressed based on individual capabilities, with therapists adjusting exercises accordingly throughout the study. In this study, both the intervention and control groups underwent a 6-week treatment plan consisting of 5 sessions per week, with each session lasting 45 minutes.

Control Group

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both ischemia and hemorrhagic stroke.
  • Stroke Patients who were in Chronic phase diagnosed by Physician were included in the study.

You may not qualify if:

  • Patient with the history of previous stroke attacks.
  • Brainstem stroke
  • Epilepsy
  • Severely impaired communication and cognition
  • Parkinson's disease and multiple sclerosis
  • Other musculoskeletal and psychological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Depalpur

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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

August 21, 2024

First Posted

September 3, 2024

Study Start

November 1, 2023

Primary Completion

May 1, 2024

Study Completion

October 30, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations