search
Back to results

Additional Effects of Scapular Stabilization Exercise With Exergaming Training in Stroke Patients

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
scapular stabilization exercises with exergaming training
exergaming training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • ShumailaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
February 23, 2023
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05673733
Brief Title
Additional Effects of Scapular Stabilization Exercise With Exergaming Training in Stroke Patients
Official Title
Additional Effects of Scapular Stabilization Exercise With Exergaming Training on Upper Limb Functions in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Exergaming can contribute to improvement of the function of UE motor and AROM in chronic stroke patients, additional studies with a large number of subjects with long follow-up periods are required to determine their effectiveness neurorehabilitation stimulation . The exergaming protocol presented in this study represents success a tool for UE functional aspects in patients with chronic stroke. It has shown improvement in gripping strength, handicrafts and UE's operational recovery. Movement control and the position of scapula determine an optimal upper limb function. Paresis leading to scapular disorientation ultimately exaggerates motor impairment in upper extremities. Recent literature has emphasized on the need to design an upper extremity protocol including scapular stabilization exercises in order to increase muscular strength and decrease scapular dyskinesis .The results of a study showed that scapular stability exercises had an impact on hand function and the ability to move hemiplegic patients after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Exergaming Training
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Exergaming training combined with Scapular stabilization exercises will be performed for 6 weeks for 3 times per week.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Exergaming training will be performed for 6 weeks for 3 times per week.
Intervention Type
Other
Intervention Name(s)
scapular stabilization exercises with exergaming training
Intervention Description
Group A will receive scapular stabilization exercises with exergaming training
Intervention Type
Other
Intervention Name(s)
exergaming training
Intervention Description
Group B will receive only exergaming training
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment tool of Upper Extremity Function
Description
To assess motor functioning, balance , sensation and joint functioning in patients with post-stroke hemiplegia. Change from baseline and 2 months
Time Frame
2 months
Title
Wolf Motor Function Test
Description
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
Time Frame
2 months
Title
Jebsen Taylor Hand Function Test
Description
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
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Misbah Ghous, MSNMPT
Phone
03345695456
Email
misbah.ghous@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Shumaila Kiran, MS*
Phone
0334 8842139
Email
docshumailakiran@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misbah Ghous, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shumaila
City
Rawalpindi
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shumaila Kiran, MSNMPT*
Phone
03348842139

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Additional Effects of Scapular Stabilization Exercise With Exergaming Training in Stroke Patients

We'll reach out to this number within 24 hrs