Subacute StrokeNCT06844253
Comparative Effects of Exergaming Versus Task Oriented Training Among Sub-acute Post-stroke Patients
A study testing INTERVENTION GROUP; TRAINING WITH EXERGAMING and Task oriented training in people with Subacute Stroke, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
This study is a randomized control trail and the purpose of this study is to determine the effects of exergaming versus task oriented training among sub-acute post-stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- INTERVENTION GROUP; TRAINING WITH EXERGAMING and Task oriented training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with sub-acute post-stroke.
- Aged 40 years-85 years.
- Mini-mental status examination >24
- Motor assessment scale (1-5 scoring)
Who cannot join
- Post-stroke patients with major cognitive deficits.
- Acute infections.
- Patients with any fracture/ MSK disorders.
- Neurological deficits other than stroke
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Foundation University College of Physical Therapy
Islamabad, 46000
About this study
This study is a randomized control trail and the purpose of this study is to determine the effects of exergaming versus task oriented training among sub-acute post-stroke patients.
Read the 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.
- Conditions
- Subacute Stroke
- Being tested
- INTERVENTION GROUP; TRAINING WITH EXERGAMING, Task oriented training
- Keywords
- Exergaming, Task-oriented training, Trunk control, sub-acute stroke, TIS, BBS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERVENTION GROUP; TRAINING WITH EXERGAMINGProcedure or surgery
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.
Task oriented trainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | 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. Receives: Procedure: INTERVENTION GROUP; TRAINING WITH EXERGAMING |
| Control Group | Active comparator | 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. Receives: Procedure: Task oriented training |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRUNK CONTROL
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.
Measured: 8 weeks
Balance
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start10 Jul 2024
- Primary completion1 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844253
- Sponsor's protocol ID
- FUI/CTR/2024/51
- Status last verified
- Feb 2025
- First submitted
- 14 Nov 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Exergaming Versus Task Oriented Training Among Sub-acute Post-stroke Patients
- ClinicalTrials.gov ID
- NCT06844253
- Acronym / sponsor ID
- FUI/CTR/2024/51
- Conditions
- Subacute Stroke
- Keywords
- Exergaming, Task-oriented training, Trunk control, sub-acute stroke, TIS, BBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized control trail and the purpose of this study is to determine the effects of exergaming versus task oriented training among sub-acute post-stroke patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Procedure: INTERVENTION GROUP; TRAINING WITH EXERGAMINGThe 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. |
| Control Group | Active comparator | Procedure: Task oriented trainingThe 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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with sub-acute post-stroke.
- Aged 40 years-85 years.
- Mini-mental status examination >24
- Motor assessment scale (1-5 scoring)
Key exclusion criteria (4 listed)
- Post-stroke patients with major cognitive deficits.
- Acute infections.
- Patients with any fracture/ MSK disorders.
- Neurological deficits other than stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTERVENTION GROUP; TRAINING WITH EXERGAMINGRANDOMIZED 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. | Procedure or surgery | Interventional Group |
| Task oriented trainingThe 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. | Procedure or surgery | Control Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTERVENTION GROUP; TRAINING WITH EXERGAMING and Task oriented training in people with Subacute Stroke, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TRUNK CONTROL (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.