- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06844253
Comparative Effects of Exergaming Versus Task Oriented Training Among Sub-acute Post-stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Effects of exergaming training will be assessed for trunk control which includes the parameters of balance and posture.
Sub-acute post stroke patients aged 40-85 years The participants will be assessed through Trunk impairment scale (TIS), Berg Blanace Scale (BBS) and biodex (clinical test for sensory integration in balance).
Informed consent will be taken after which the participants will be recruited into the two groups, where one group will receive intervention through exergaming and other group will receive task oriented trainig.
Baseline and post-treatment measurements will be taken for analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Islamabad, Pakistan, 46000
- Foundation University College of Physical Therapy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with sub-acute post-stroke.
- Aged 40 years-85 years.
- Mini-mental status examination >24
- Motor assessment scale (1-5 scoring)
Exclusion Criteria:
- Post-stroke patients with major cognitive deficits.
- Acute infections.
- Patients with any fracture/ MSK disorders.
- Neurological deficits other than stroke
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interventional Group
The participants will receive intervention through exergaming XBOX 360 which includes Kinect 20,000 leaks, Kinect bubble pop and Kinect rally ball trunk exercises. week 1-2 Kinect bubble pop (beginner level), Kinect 20000 leaks (beginner level) week 3-4 Kinect bubble pop (intermediate level), Kinect 20000 leaks (intermediate level) week5-6 Kinect rally ball (beginner level), Kinect bubble pop (advanced level) week7-8 Kinect rally ball (intermediate and advanced level) total 8 weeks. 3 days per week session will be given for 30 minutes including 5 minutes warm up and cool down and 5 minutes of break in between to avoid fatigue. |
RANDOMIZED CONTROL TRIAL EXERGAMING KINECT 20,000 LEAKS , KINECT BUBBLE POP, KINECT RALLY BALL GROUP 2: TASK ORIENTED TRAINING TRANSFERRING OBJECTS FROM ONE SIDE TO OTHER SIDE OF TABLE CATCHING AND THROWING BALLSIN DIFFERENT DIRECTIONS PICKING UP OBJECTS FROM LESS HIGHTED TABLES.
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|
Active Comparator: Control Group
The participant will receive task oriented training consisting of different tasks in sitting and standing position. week1-2 sitting position: throwing and catching balls standing position: picking up glass from less heighted table . week 3-4 sitting position: transferring the plastic rings from one corner of table to another. standing position: catching balls from multiple directions. wee5-6 sitting position: picking objects from floor standing position: opening drawer from less heighted tables week 7-8 standing position: picking up and transferring bottles, jars at different locations on table standing position: removing stickers from wall time of session: 15-20 repetitions, 2 sets. 30 minutes of session with 5 minutes rest in between. the intervention will be given for 30 minutes , 3 days a week for total 8 weeks of time period. |
The participant will receive task oriented training consisting of different tasks in sitting and standing position. week1-2 sitting position: throwing and catching balls standing position: picking up glass from less heighted table . week 3-4 sitting position: transferring the plastic rings from one corner of table to another. standing position: catching balls from multiple directions. wee5-6 sitting position: picking objects from floor standing position: opening drawer from less heighted tables week 7-8 standing position: picking up and transferring bottles, jars at different locations on table standing position: removing stickers from wall time of session: 15-20 reps, 2 sets. 30 minutes of session with 5 minutes rest in between. the intervention will be given for 30 minutes , 3 days a week for total 8 weeks of time period. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TRUNK CONTROL
Time Frame: 8 weeks
|
It will be assessed by trunk impairment scale.
for trunk control : trunk impairment scale has total scoring 0-16.
0= severe impairment, 16=no impairment.
trunk impairment scale will measure the trunk control in static sitting and static standing.
and in rotational movements in left and right direction.
|
8 weeks
|
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Balance
Time Frame: 8 weeks
|
assessed by berg balance scale for balance berg balance scale has total scoring 56.
0-20=severe impairment, 21-40=moderate impairment, 41-56=mild impairment.
berg balance scale will measure the static and dynamic balance in both sitting and standing position.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/51
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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