StrokeNCT06478069
Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization
A study testing Group A and Group B in people with Stroke, run by Superior University at 1 site in Pakistan.
Trial summary
This study focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. It first investigates the application of pose estimating technologies to objectively measure posture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Group A and Group B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 30 Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke, either ischemic or hemorrhagic
- Standing ability and ability to perform basic movements with assistance
- Willingness to take part in the intervention and evaluations
Who cannot join
- Severe cognitive impairment hindering participation
- Unstable medical conditions affecting rehabilitation
- History of other neurological disorders affecting posture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization Techniques
This study focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. It first investigates the application of pose estimating technologies to objectively measure posture.
Read the detailed description
This can entail capturing a patient's body position with cameras or other sensors in order to detect any imbalances or variations from normal posture brought on by the stroke. The study also looks at how well dynamic core postural chain stabilization (DCS) methods work for stroke recovery. The goal of DCS exercises is to increase stability and strength in the core, which can help with general postural control. This research aims to optimize stroke patient rehabilitation by combining a precise evaluation approach with a focused intervention strategy, which may result in improved balance, movement, and functional abilities.
- Conditions
- Stroke
- Being tested
- Group A, Group B
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADiagnostic test
Group A was treated with Ibuprofen Dosage After breakfast and after dinner for 6 weeks.
Group BBehavioural
Group B was treated with physical therapy; (Upper limb: The stroke patient warmed up with some gentle stretches for the wrist and fingers to get the muscles ready. They subsequently engaged in resistance training using dumbbells or resistance bands to increase the strength of their upper limbs. Bicep curls, tricep extensions, and shoulder presses were some of these exercises. They tried to complete two to three sets of ten to fifteen repetitions for each exercise, progressively increasing the resistance as their strength increased. Then, to improve dexterity and coordination in daily tasks, functional exercises were included.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Not described Receives: Diagnostic Test: Group A |
| Group B | Experimental | Not described Receives: Behavioral: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
For evaluating balance in a variety of functional tasks, the BBS is a commonly used and validated test. After the intervention period, the BBS scores of the control group and the intervention group (who received DCS techniques) can be compared. The efficacy of DCS in enhancing postural control would be strongly supported by a statistically significant increase in the intervention group's BBS score.
Measured: 12 Months
Trunk Impairment Scale (TIS) Score
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. In a recent version of the TIS (version 2.0) for adults, the static subscale was removed because of a ceiling effect, total score ranges between 0 and 16 points
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Oct 2023
- Primary completion1 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478069
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/722
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization Techniques
- ClinicalTrials.gov ID
- NCT06478069
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/722
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 27 Jun 2024 (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 focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. It first investigates the application of pose estimating technologies to objectively measure posture.
Detailed description
This can entail capturing a patient's body position with cameras or other sensors in order to detect any imbalances or variations from normal posture brought on by the stroke. The study also looks at how well dynamic core postural chain stabilization (DCS) methods work for stroke recovery. The goal of DCS exercises is to increase stability and strength in the core, which can help with general postural control. This research aims to optimize stroke patient rehabilitation by combining a precise evaluation approach with a focused intervention strategy, which may result in improved balance, movement, and functional abilities.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Diagnostic Test: Group A |
| Group B | Experimental | Behavioral: Group B |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke, either ischemic or hemorrhagic
- Standing ability and ability to perform basic movements with assistance
- Willingness to take part in the intervention and evaluations
Key exclusion criteria (3 listed)
- Severe cognitive impairment hindering participation
- Unstable medical conditions affecting rehabilitation
- History of other neurological disorders affecting posture
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 |
|---|---|---|
| Group AGroup A was treated with Ibuprofen Dosage After breakfast and after dinner for 6 weeks. | Diagnostic test | Group A |
| Group BGroup B was treated with physical therapy; (Upper limb: The stroke patient warmed up with some gentle stretches for the wrist and fingers to get the muscles ready. They subsequently engaged in resistance training using dumbbells or resistance bands to increase the strength of their upper limbs. Bicep curls, tricep extensions, and shoulder presses were some of these exercises. They tried to complete two to three sets of ten to fifteen repetitions for each exercise, progressively increasing the resistance as their strength increased. Then, to improve dexterity and coordination in daily tasks, functional exercises were included. | Behavioural | Group B |
Primary outcome
Berg Balance Scale
Time frame: 12 Months
For evaluating balance in a variety of functional tasks, the BBS is a commonly used and validated test. After the intervention period, the BBS scores of the control group and the intervention group (who received DCS techniques) can be compared. The efficacy of DCS in enhancing postural control would be strongly supported by a statistically significant increase in the intervention group's BBS score.
Trunk Impairment Scale (TIS) Score
Time frame: 12 months
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. In a recent version of the TIS (version 2.0) for adults, the static subscale was removed because of a ceiling effect, total score ranges between 0 and 16 points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No
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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 Group A and Group B in people with Stroke, run by Superior University 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2024. 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?
Results are not available in the source record.
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?
Berg Balance Scale (time frame: 12 Months). 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 27 Jun 2024.