NCT05570032

Brief Summary

This single group quasi-experimental study was conducted at Rafsan Neuro Rehab Center, Peshawar from October 2021 to February 2022. The sample size of study was 40 post stroke patients who were diagnosed on physical findings and other investigation like CT and MRI. The inclusion criteria were set as post-stroke patients for more than 3 months with 20 and above score on MAS scale and age of 55 to 65 years, while the exclusion criteria were defined as participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia, patients having recurrent episodes of stroke, stroke patient with dementia and score on MAS scale below 20.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

October 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

September 26, 2022

Last Update Submit

October 9, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • TUG test

    Objective of the TUG test is to determine fall risk and measure the progress of balance, sit to stand and walking.

    8 weeks

  • MAS scale

    The Motor Assessment Scale (MAS) is a performance-based scale used to assess level of impairment and everyday motor function in patients with stroke.

    8 weeks

  • Forward stepping test

    Forward stepping test is used to assess the balance of the patients with stroke or other neurological disorder.

    8 weeks

  • Functional reach test

    The Functional reach test assesses a patient's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.

    8 weeks

Study Arms (1)

virtual reality training

EXPERIMENTAL

In intervention the participants took part in the VR training. The X-BOX 360 (Augmented virtual reality) device was used. The participants were guided about the virtual reality training including Kinect sports gamming (Trail 1. badminton, beach volley ball, Soccer goal keeping). Each training was performed for 15 minutes with 5 minutes break time. The whole training was performed for 8 weeks. After eight weeks final assessment was done through outcome measuring tools (TUG test, MAS scale, forward stepping test and Functional reach test).

Device: Virtual Reality Training

Interventions

In intervention the participants took part in the VR training. The X-BOX 360 (Augmented virtual reality) device was used. The participants were guided about the virtual reality training including Kinect sports gamming (Trail 1. badminton, beach volley ball, Soccer goal keeping). Each training was performed for 15 minutes with 5 minutes break time. The whole training was performed for 8 weeks. After eight weeks final assessment was done through outcome measuring tools (TUG test, MAS scale, forward stepping test and Functional reach test).

virtual reality training

Eligibility Criteria

Age55 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and above score on MAS scale
  • age of 55 to 65 years

You may not qualify if:

  • participants having traumatic brain injuries, degenerative brain diseases, post craniotomy tumor patients leading to hemiplegia,
  • patients having recurrent episodes of stroke,
  • stroke patient with dementia
  • score on MAS scale below 20.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hazrat Bilal

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Shakir Ullah, MSPT

    Khyber Medical University Peshawar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Co-Invistigator

Study Record Dates

First Submitted

September 26, 2022

First Posted

October 6, 2022

Study Start

October 4, 2021

Primary Completion

February 12, 2022

Study Completion

February 25, 2022

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations