NCT05673733

Brief Summary

The World Health Organization has termed stroke to be a clinical syndrome, of presumed vascular origin, typified by rapidly developing signs of focal or global disturbance of cerebral functions and the leading cause of death worldwide in 2016 making it a major non-contagious cause of death. This study would be beneficial in a way that it will give a valuable input and will contribute for the knowledge of interventions for stroke with an emphasis on upper extremity function among health care practitioners for their goal of promoting health, prevention of diseases and improving quality of life.

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

Click on a node to explore related trials.

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

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer Assessment tool of Upper Extremity Function

    To assess motor functioning, balance , sensation and joint functioning in patients with post-stroke hemiplegia. Change from baseline and 2 months

    2 months

  • Wolf Motor Function Test

    It quantifies upper extremity (UE) motor ability through timed and functional tasks. The items are rated on a 6-point scale. Change from baseline and 2 months

    2 months

  • Jebsen Taylor Hand Function Test

    It is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). \- Scoring: The JTHFT has seven subsets which are writing, simulated page-turning, lifting small objects, stimulated feeding, stacking, and lifting large, lightweight, and heavy objects. Total score is the sum of time taken for each sub-test, which are rounded to the nearest second. Shorter times indicate better performance. Change from baseline and 2 months

    2 months

Study Arms (2)

Group A

EXPERIMENTAL

Exergaming training combined with Scapular stabilization exercises will be performed for 6 weeks for 3 times per week.

Other: scapular stabilization exercises with exergaming training

Group B

ACTIVE COMPARATOR

Exergaming training will be performed for 6 weeks for 3 times per week.

Other: exergaming training

Interventions

Group A will receive scapular stabilization exercises with exergaming training

Group A

Group B will receive only exergaming training

Group B

Eligibility Criteria

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

You may qualify if:

  • Chronic Stroke patients with an initial onset of 6 months or above.
  • Those who had 30-65 points by Fugl-Meyer Assessment of upper extremity
  • Those who had minimum score 24 on mini mental state examination
  • Those who have the ability to execute at least 20' of active shoulder flexion and abduction against gravity those who could understand and follow instructions provided by the investigator
  • Those who are medically stable enough to participate in active rehab
  • Those who have no problems with auditory or visual functioning.
  • Modified Ashworth Scale (MAS) 1-3

You may not qualify if:

  • Orthopaedic or mental health problems
  • Those who have difficulty to stay in a sitting position
  • Severe conditions such as uncontrolled blood pressure or angina
  • History of epilepsy
  • The refusal to play a video game.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shumaila

Rawalpindi, 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Misbah Ghous, MSNMPT

CONTACT

Shumaila Kiran, MS*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
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