Chronic StrokeNCT06346652
Effects of Core Strengthening and PNF Pattern on Static Balance and Plantar Pressure in Chronic Stroke Patients
A study testing Routine Physical Therapy and Routine Physical Therapy+ PNF and Core Stregthening in people with Chronic Stroke, run by University of Lahore at 1 site in Pakistan.
Trial summary
Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Routine Physical Therapy and Routine Physical Therapy+ PNF and Core Stregthening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2024to 30 Apr 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age (45-60 years)
- Score of 9 or Higher on static component of berg balance scale
- Having score of equal or less than 2 on Modified Ashworth scale
- Having score of greater than or equal to 24 on Mini Mental State Examination.
- First ever episode of stroke
- Duration of stroke greater than 6 months
- Both genders
Who cannot join
- Concurrent orthopedic conditions that may hamper standing
- Relevant psychiatric disorders that may prevent from following instructions.
- Medical drugs that may influence intervention
- Conditions contraindicating physical activity
- Use of Cardiac pace maker.
Trial locations and contacts
1 site in 1 country.
About this study
Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.
This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients.
Read the detailed description
Background: Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.
Objective: To compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients.
Methodology: 73 patients were enrolled in this study, 37 patients were assigned into control group while 36 participants were assigned into experimental group. Control group received routine physical therapy while experimental group received core strengthening and proprioceptive neuromuscular technique. Static component of berg balance scale and PoData Stabiliometeric plate was used for plantar pressure and measurement of balance respectively.
- Conditions
- Chronic Stroke
- Being tested
- Routine Physical Therapy, Routine Physical Therapy+ PNF and Core Stregthening
- Keywords
- core strengthening, plantar pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physical TherapyOther
Routine physical therapy involving muscle strengthening exercises, range of motion exercises and stretching exercises up to patient's tolerance. Other exercises were pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, wobble board exercises. Each session was of 60 minutes 5 times weekly for 6 weeks.
Routine Physical Therapy+ PNF and Core StregtheningOther
Routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals were performed in lower extremity in D1 flexion pattern and D1 extension pattern up to patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Routine Physical Therapy Receives: Other: Routine Physical Therapy |
| Interventional Group | Experimental | Routine Physical Therapy + PNF + Core Strengthening Receives: Other: Routine Physical Therapy+ PNF and Core Stregthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Standing Balance
Measure using static component of berg balance scale. The items are scored from 0 to 4 with a score of 0 representing an inability to complete the task. Score of 4 representing independent item completion.
Measured: 6 weeks
Secondary outcomes (1)
Plantar Pressure
Foot plantar pressure is the pressure field that acts between the foot and support surface during static standing. PoData Stabiliometric plate was used to measure it. Normal value is 16.67% of the body weight on 5th metatarsal.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start10 Mar 2024
- Primary completion22 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safa Saleem, University of Lahore
- Investigators
- Safa Saleem, MSPTN, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346652
- Sponsor's protocol ID
- REC-UOL-216-03-2024
- Status last verified
- Jul 2024
- First submitted
- 21 Mar 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Strengthening and PNF Pattern on Static Balance and Plantar Pressure in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06346652
- Acronym / sponsor ID
- REC-UOL-216-03-2024
- Conditions
- Chronic Stroke
- Keywords
- core strengthening, plantar pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 4 Apr 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.
Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.
This study aims to compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients.
Detailed description
Background: Stroke is a neurological disease characterized by neurological deficits caused by insufficiency of blood supply to brain. Disruption of blood supply to brain can be due to blockage of blood supply (ischemic) or leakage of blood in brain due to rupture of blood vessel (hemorrhagic). 90.5% of global occurrence of stroke was subjected to modifiable risk factors according to Global Burden of Disease study.
Objective: To compare the effects of core strengthening and proprioceptive neuromuscular facilitation on static standing balance and plantar pressure in chronic stroke patients.
Methodology: 73 patients were enrolled in this study, 37 patients were assigned into control group while 36 participants were assigned into experimental group. Control group received routine physical therapy while experimental group received core strengthening and proprioceptive neuromuscular technique. Static component of berg balance scale and PoData Stabiliometeric plate was used for plantar pressure and measurement of balance respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Routine Physical TherapyRoutine Physical Therapy |
| Interventional Group | Experimental | Other: Routine Physical Therapy+ PNF and Core StregtheningRoutine Physical Therapy + PNF + Core Strengthening |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age (45-60 years)
- Score of 9 or Higher on static component of berg balance scale
- Having score of equal or less than 2 on Modified Ashworth scale
- Having score of greater than or equal to 24 on Mini Mental State Examination.
- First ever episode of stroke
Key exclusion criteria (5 listed)
- Concurrent orthopedic conditions that may hamper standing
- Relevant psychiatric disorders that may prevent from following instructions.
- Medical drugs that may influence intervention
- Conditions contraindicating physical activity
- Use of Cardiac pace maker.
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 |
|---|---|---|
| Routine Physical TherapyRoutine physical therapy involving muscle strengthening exercises, range of motion exercises and stretching exercises up to patient's tolerance. Other exercises were pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, wobble board exercises. Each session was of 60 minutes 5 times weekly for 6 weeks. | Other | Control Group |
| Routine Physical Therapy+ PNF and Core StregtheningRoutine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals were performed in lower extremity in D1 flexion pattern and D1 extension pattern up to patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks. | Other | Interventional Group |
Primary outcome
Static Standing Balance
Time frame: 6 weeks
Measure using static component of berg balance scale. The items are scored from 0 to 4 with a score of 0 representing an inability to complete the task. Score of 4 representing independent item completion.
1 secondary outcome
Plantar Pressure
Time frame: 6 weeks
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 23 Jul 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.
Safa Saleem, MSPTN principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physical Therapy and Routine Physical Therapy+ PNF and Core Stregthening in people with Chronic Stroke, 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 7 inclusion and 5 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 23 Jul 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?
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?
Static Standing Balance (time frame: 6 weeks). 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 23 Jul 2024.