Stroke; ParalysisPNFNCT05436782
Effects of Core Strengthening and PNF Pattern on Balance and Plantar Pressure in Chronic Stroke
A study testing core strengthening exercises and Routine physical therapy in people with Stroke; Paralysis, run by University of Lahore at 1 site in Pakistan.
Trial summary
To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke; Paralysis
- What is being tested?
- core strengthening exercises and Routine physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Dec 2021to 14 Aug 2022
- 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
- Score of 9 or higher on the static component of Berg Balance Scale
- Both genders will be recruited.
- First ever episode of stroke
- Duration of stroke greater than 6 months.
- Having a score of equal to or less than 2 on the Modified Ashworth Scale
- Having a score of greater than or equal to 24 on the Mini-mental state examination in order to understand the commands.
Who cannot join
- • Concurrent orthopedic (for e.g. amputation ) that may hamper standing
- Relevant psychiatric disorders that may prevent from following instructions.
- Other medical drugs that may influence our intervention
- Condition contraindicating physical activity
- Use of cardiac pacemakers.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
The University of Lahore Teaching Hospital
Lahore, Punjqb, 40050
Wardah Rauf, MSPTN, 03374915954, wardahrauf99@gmail.com
About this study
Official title: Effects of Core Strengthening and Proprioceptive Neuromuscular Facilitation Pattern on Static Standing Balance and Plantar Pressure in Chronic Stroke
To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients
Read the detailed description
The effects of different exercise regimes and PNF techniques on balance and plantar pressure had been studied. This study focuses on determining the effects of CSE and PNF techniques on developing static standing balance and plantar pressure in stroke patients using PoData
- Conditions
- Stroke; Paralysis
- Being tested
- core strengthening exercises, Routine physical therapy
- Keywords
- Stroke, Static Balance, PNF, Plantar Pressure, PoData
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
core strengthening exercisesOther
•Group B (experimental group) received routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals were performed in the lower extremity in D1 flexion pattern and D1 extension pattern up to the patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks. The outcome measure was measured at baseline and 6th-week interval
Routine physical therapyOther
•Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance. Other exercises were pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises. Each session was of 60 minutes 5 times weekly for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | • Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance. Other exercises will be pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises. Each session will be of 60 minutes 5 times weekly for 6 weeks Receives: Other: Routine physical therapy |
| Group B | Experimental | Group B (experimental group) will receive routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals will be 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. The outcome measure will be measured at and 6th week interval Receives: Other: core strengthening exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Standing balance
It is measured 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 and a score of 4 representing independent item completion. Static component score is calculated out of 24 possible points. Scores of 0 to 9 represent static balance impairment, 10 to 15 represent acceptable static balance, and 15 to 24 represent good static balance
Measured: 6 months
Secondary outcomes (1)
Plantar pressure
PoData (Chinesport, Italy Version 5.0) this system provides information about weight distribution by measuring total body weight on fifth, first metatarsal and heel For a healthy individual the normal distribution is as follows 16.67% of the total body weight on the fifth metatarsal head, 33.33% of the total body weight on first metatarsal. 50% of the total body weight on heel
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start3 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion14 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke; ParalysisStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sameed Liaqat, DPT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436782
- Sponsor's protocol ID
- IRB-UOL-FAHS/1089/2021
- Acronym
- PNF
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 29 Jun 2022
- 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 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Strengthening and Proprioceptive Neuromuscular Facilitation Pattern on Static Standing Balance and Plantar Pressure in Chronic Stroke
- ClinicalTrials.gov ID
- NCT05436782
- Acronym / sponsor ID
- PNF / IRB-UOL-FAHS/1089/2021
- Conditions
- Stroke; Paralysis
- Keywords
- Stroke, Static Balance, PNF, Plantar Pressure, PoData
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 3 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 14 Aug 2022 (estimated)
- First posted
- 29 Jun 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.
To compare the effects of core strengthening and PNF on standing balance and plantar pressure in chronic stroke patients
Detailed description
The effects of different exercise regimes and PNF techniques on balance and plantar pressure had been studied. This study focuses on determining the effects of CSE and PNF techniques on developing static standing balance and plantar pressure in stroke patients using PoData
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Routine physical therapy• Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance. Other exercises will be pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises. Each session will be of 60 minutes 5 times weekly for 6 weeks |
| Group B | Experimental | Other: core strengthening exercisesGroup B (experimental group) will receive routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals will be 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. The outcome measure will be measured at and 6th week interval |
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
Key exclusion criteria (5 listed)
- • Concurrent orthopedic (for e.g. amputation ) that may hamper standing
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 strengthening exercises•Group B (experimental group) received routine physical therapy for 20 minutes and additionally PNF technique (rhythmic initiation, and then agonistic reversals were performed in the lower extremity in D1 flexion pattern and D1 extension pattern up to the patient's tolerance and core strengthening for 20 minutes 5 times weekly for 6 weeks. The outcome measure was measured at baseline and 6th-week interval | Other | Group B |
| Routine physical therapy•Group A (control group) will receive routine physical therapy involving muscle strengthening exercises, range of motion exercises, and stretching exercises up to the patient's tolerance. Other exercises were pelvic bridging, rolling, sitting and standing exercises, walking practice and balancing in parallel bars, and wobble board exercises. Each session was of 60 minutes 5 times weekly for 6 weeks | Other | Group A |
Primary outcome
Static Standing balance
Time frame: 6 months
It is measured 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 and a score of 4 representing independent item completion. Static component score is calculated out of 24 possible points. Scores of 0 to 9 represent static balance impairment, 10 to 15 represent acceptable static balance, and 15 to 24 represent good static balance
1 secondary outcome
Plantar pressure
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
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Post-Stroke Apraxia, Motor Function, Balance, and Gait
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Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
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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.
Sameed Liaqat, DPT 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 core strengthening exercises and Routine physical therapy in people with Stroke; Paralysis, 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: status not confirmed, as of the sponsor's last update on 29 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameed Liaqat, DPT (0324 9004200, samiliaqat3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Standing balance (time frame: 6 months). 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 29 Jun 2022.