StrokeNCT06267079
Core Stability, Symmetrical Weight-bearing Stroke
A study testing core stability exercise in people with Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
To evaluate the effect of core stability exercise on symmetrical weight bearing in chronic stroke patients? Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- core stability exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jan 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Forty hemiparetic patients were diagnosed and referred to by a neurologist.
- All patients must be ambulant
- The spasticity of lower limbs ranges from (grade 1: 1+) according to Modified Ashworth Scale.
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale >24). (
- Age ranges from 50 to 65 years in both sexes.
- Duration of stroke was more than 6 months up to 24 months. -
Who cannot join
- The patients were excluded if they had any of the following:
- Musculoskeletal disorders such as severe arthritis grade (3-4) of osteoarthritis, lower limb fractures less than 6 months or contractures of fixed deformity.
- Cognitive impairment (a score less than 24 according to the MMSE)
- Patients with diabetic neuropathy.
- Recurrent stroke.
- Rheumatologic or endocrinologic disorders that may cause ROM restriction.
- Patients suffering from cognitive, or emotional disturbance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Core Stability Exercise on Symmetrical Weight Bearing in Chronic Stroke Patient
To evaluate the effect of core stability exercise on symmetrical weight bearing in chronic stroke patients?
Read the detailed description
Stroke is a syndrome characterized by quickly emerging clinical indicators of a focal (or global) disruption of brain function. The symptoms can last for more than 24 hours or even result in death, and there is no known reason for them other than vascular origin. Over 80% of all strokes are caused by an ischemic stroke. A large artery blockage typically results in tissue infarction, which is the non-selective loss of all brain cells in the affected areas of the brain if it is not quickly reversed. Determining the location and size of these infarcts is crucial. the long-term functional deficits resulting from ischemic stroke. After a stroke, patients' ability to bear weight symmetrically is similarly compromised; they may bear between 61 and 80% of their body weight on a non-paretic leg. Physiotherapy procedures targeted at enhancing core stability can enhance the lumbopelvic-hip musculature's strength, coordination, and endurance, potentially reducing physical deficits linked to compromised trunk function. Because these muscles are crucial for both stability and lumbar posture control (by the employment of Core stability is commonly utilized in whole-body exercises to enhance the strength of the muscles around the stomach, lumbar, and pelvic regions, whether they be tonic or postural muscles. The trunk is the body's center pivot point, serving as a vital component for functional activity, balance, postural control, and extremity coordination. Consequently, the trunk is very important. in the recovery procedure. There is a substantial body of research demonstrating that Trunk control, balance when sitting and standing, and mobility can all be improved with trunk training. in stroke patients, according to recent studies in systemic reviews. So, the purpose of the current study was to detect the effect of core stability exercise on symmetrical weight bearing in patients with chronic stroke
- Conditions
- Stroke
- Being tested
- core stability exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core stability exerciseOther
Each participant in the group (A) underwent eighteen sessions of core stability exercises very other day for one and half months, 3 sessions /week, each session for 1hour (30 minutes for core exercises then 30 minutes Selected physical therapy program).
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | Core stability Exercises. Each participant in the group (A) underwent eighteen sessions of core stability exercises very other day for one and half months, 3 sessions /week, each session for 1hour (30 minutes for core exercises then 30 minutes Selected physical therapy program).
+ Selected physical therapy program. Receives: Other: core stability exercise |
| control group | Other | Selected physical therapy program. all participants in both groups (A \& B) had three sessions per week for a month and a half, every other day. of Selected physical therapy program which consist of (Exercises for tone modulation, balance, lower limb muscular strengthening, and stretching) Receives: Other: core stability exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Each patient was assessed by Balance Berg scales pretreatment. and repeated Measurements were taken after treatment. Each patient was assessed by Digital weight scale and Balance Berg scales
The Berg Balance Scale (BBS) was used to assess static and dynamic balance
Measured: six weeks
Each patient was assessed by Digital weight scale pre treatment and repeated Measurements were taken after treatment.
Digital weight scale:
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jun 2023
- Primary completion5 Sep 2023
- Study completion1 Jan 2024
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 Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Arafa Abdel Halim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267079
- Sponsor's protocol ID
- core stability
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Core Stability Exercise on Symmetrical Weight Bearing in Chronic Stroke Patient
- ClinicalTrials.gov ID
- NCT06267079
- Acronym / sponsor ID
- core stability
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Feb 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.
To evaluate the effect of core stability exercise on symmetrical weight bearing in chronic stroke patients?
Detailed description
Stroke is a syndrome characterized by quickly emerging clinical indicators of a focal (or global) disruption of brain function. The symptoms can last for more than 24 hours or even result in death, and there is no known reason for them other than vascular origin. Over 80% of all strokes are caused by an ischemic stroke. A large artery blockage typically results in tissue infarction, which is the non-selective loss of all brain cells in the affected areas of the brain if it is not quickly reversed. Determining the location and size of these infarcts is crucial. the long-term functional deficits resulting from ischemic stroke. After a stroke, patients' ability to bear weight symmetrically is similarly compromised; they may bear between 61 and 80% of their body weight on a non-paretic leg. Physiotherapy procedures targeted at enhancing core stability can enhance the lumbopelvic-hip musculature's strength, coordination, and endurance, potentially reducing physical deficits linked to compromised trunk function. Because these muscles are crucial for both stability and lumbar posture control (by the employment of Core stability is commonly utilized in whole-body exercises to enhance the strength of the muscles around the stomach, lumbar, and pelvic regions, whether they be tonic or postural muscles. The trunk is the body's center pivot point, serving as a vital component for functional activity, balance, postural control, and extremity coordination. Consequently, the trunk is very important. in the recovery procedure. There is a substantial body of research demonstrating that Trunk control, balance when sitting and standing, and mobility can all be improved with trunk training. in stroke patients, according to recent studies in systemic reviews. So, the purpose of the current study was to detect the effect of core stability exercise on symmetrical weight bearing in patients with chronic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Other: core stability exerciseCore stability Exercises. Each participant in the group (A) underwent eighteen sessions of core stability exercises very other day for one and half months, 3 sessions /week, each session for 1hour (30 minutes for core exercises then 30 minutes Selected physical therapy program). + Selected physical therapy program. |
| control group | Other | Other: core stability exerciseSelected physical therapy program. all participants in both groups (A \& B) had three sessions per week for a month and a half, every other day. of Selected physical therapy program which consist of (Exercises for tone modulation, balance, lower limb muscular strengthening, and stretching) |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Forty hemiparetic patients were diagnosed and referred to by a neurologist.
- All patients must be ambulant
- The spasticity of lower limbs ranges from (grade 1: 1+) according to Modified Ashworth Scale.
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale >24). (
- Age ranges from 50 to 65 years in both sexes.
Key exclusion criteria (7 listed)
- The patients were excluded if they had any of the following:
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 |
|---|---|---|
| core stability exerciseEach participant in the group (A) underwent eighteen sessions of core stability exercises very other day for one and half months, 3 sessions /week, each session for 1hour (30 minutes for core exercises then 30 minutes Selected physical therapy program). | Other | control group, study group |
Primary outcome
Each patient was assessed by Balance Berg scales pretreatment. and repeated Measurements were taken after treatment. Each patient was assessed by Digital weight scale and Balance Berg scales
Time frame: six weeks
The Berg Balance Scale (BBS) was used to assess static and dynamic balance
Each patient was assessed by Digital weight scale pre treatment and repeated Measurements were taken after treatment.
Time frame: 6 week
Digital weight scale:
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 20 Feb 2024.
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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 core stability exercise in people with Stroke, run by Cairo University at 1 site in Egypt.
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 6 inclusion and 7 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 20 Feb 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 Egypt. 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?
Each patient was assessed by Balance Berg scales pretreatment. and repeated Measurements were taken after treatment. Each patient was assessed by Digital weight scale and Balance Berg scales (time frame: six 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 20 Feb 2024.