Ischemic Stroke, AcuteNCT05510258
Comparison of Routine and Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Stroke Patients
A study testing Physiotherapy in people with Ischemic Stroke, Acute, run by University of Lahore at 1 site in Pakistan.
Trial summary
This is ROM trail study. Data collected from Rabbani Hospital Lahore . in this study total two groups included control and experimental and sample size was 48 and 24 persons divided in each groups as well. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Jan 2020to 5 Mar 2021
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sub-Acute ischemic and stroke diagnosed by neuro-physican having 1st episode
- Patients in sub-acute stage (2-12 weeks)
- Patients who can follow the instruction according to mini mental scale < 7
- Minimum score of a patient on burg balance and trunk impairment scale to enter in rehab unit and include in any research i-e TIS < 2 in scoring and BBS < 4 minimum scoring.
Who cannot join
- Recurrent stroke
- Subjects with radiating pain or nerve root involvement
- Diagnosed by any neurological condition other than stroke, or other clinical comorbidity that affect the trunk balance.
- Patient unable to follow the instructions
- Comprehension deficits that prevented them from following verbal commands
- Unconscious patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Routine Physical Therapy With and Without Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Sub-acute Ischemic Stroke Patient
This is ROM trail study. Data collected from Rabbani Hospital Lahore . in this study total two groups included control and experimental and sample size was 48 and 24 persons divided in each groups as well. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Data analyse by ssps V21.0 with a significant level of p valued 0.05. Results were in the favour of experimental group.
Read the detailed description
This is ROM trail study. Data collected from Physiotherapy department of Rabbani Hospital Lahore . In this study total two groups included control and experimental and sample size was 48 and 24 persons randomly allocated in each groups as well. In control group conventional therapy given while in experimental group core-stability exercises with conventional therapy given to the patients. while the duration of therapy was 45 minutes per day for 8 weeks. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Only having first episode of sub-acute stoke patients and diagnosed by Neuro-physician were included in study. Data entered and analysed by SSPS V21.0 with a significant level of p valued 0.05. and the results were in the favour of study means experimental group.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Physiotherapy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
TWO GROUPS CONTROL ND EXPERIMENTAL
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | core-stability exercises therapy given with conventional therapy Receives: Other: Physiotherapy |
| control group | Other | only conventional therapy given Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Berg balance scale at week 4
Berg balance scale(BBS) used clinical test of a person's static and dynamic balance abilities. BBS comprises a set of 14 items which includes unsupported sitting to unsupported standing and weight shifting while standing unsupported.
- Lower score =1 (Sitting to standing)
- Higher score=14 (weight shifting while standing)
Measured: Baseline and 4 weeks
Change from baseline in Trunk impairment scale at week 4
The Trunk Impairment Scale (TIS) is a tool to measure motor impairment of the trunk after stroke. TIS scores on a range from 0 to 23. Static sitting balance, Dynamic sitting balance and Co-ordination will be evaluated by this scale.
- Static sitting balance=7
- Dynamic sitting balance=10
- Co-ordination=6
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start7 Jan 2020
- Primary completion2 Mar 2020
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups control and experimental included
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabbani Hospital, Study chair, PMDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510258
- Sponsor's protocol ID
- IRB-UOL-FAHS/718-XV/2020
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Routine Physical Therapy With and Without Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Sub-acute Ischemic Stroke Patient
- ClinicalTrials.gov ID
- NCT05510258
- Acronym / sponsor ID
- IRB-UOL-FAHS/718-XV/2020
- Conditions
- Ischemic Stroke, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 22 Aug 2022 (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 is ROM trail study. Data collected from Rabbani Hospital Lahore . in this study total two groups included control and experimental and sample size was 48 and 24 persons divided in each groups as well. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Data analyse by ssps V21.0 with a significant level of p valued 0.05. Results were in the favour of experimental group.
Detailed description
This is ROM trail study. Data collected from Physiotherapy department of Rabbani Hospital Lahore . In this study total two groups included control and experimental and sample size was 48 and 24 persons randomly allocated in each groups as well. In control group conventional therapy given while in experimental group core-stability exercises with conventional therapy given to the patients. while the duration of therapy was 45 minutes per day for 8 weeks. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Only having first episode of sub-acute stoke patients and diagnosed by Neuro-physician were included in study. Data entered and analysed by SSPS V21.0 with a significant level of p valued 0.05. and the results were in the favour of study means experimental group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Two groups control and experimental included
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Physiotherapycore-stability exercises therapy given with conventional therapy |
| control group | Other | Other: Physiotherapyonly conventional therapy given |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| PhysiotherapyTWO GROUPS CONTROL ND EXPERIMENTAL | Other | control group, experimental group |
Primary outcome
Change from baseline in Berg balance scale at week 4
Time frame: Baseline and 4 weeks
Berg balance scale(BBS) used clinical test of a person's static and dynamic balance abilities. BBS comprises a set of 14 items which includes unsupported sitting to unsupported standing and weight shifting while standing unsupported. * Lower score =1 (Sitting to standing) * Higher score=14 (weight shifting while standing)
Change from baseline in Trunk impairment scale at week 4
Time frame: Baseline and 4 weeks
The Trunk Impairment Scale (TIS) is a tool to measure motor impairment of the trunk after stroke. TIS scores on a range from 0 to 23. Static sitting balance, Dynamic sitting balance and Co-ordination will be evaluated by this scale. * Static sitting balance=7 * Dynamic sitting balance=10 * Co-ordination=6
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 22 Aug 2022.
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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.
Rabbani Hospital study chair
PMDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Ischemic Stroke, Acute, run by University of Lahore 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 6 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 22 Aug 2022. 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?
Change from baseline in Berg balance scale at week 4 (time frame: Baseline and 4 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 22 Aug 2022.