StrokeNCT05707065
Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques in Chronic Stroke Patients
A study testing core strengthening exercises and Proprioceptive Neuromuscular Facilitation in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke is a global healthcare issue that causes increased death rates. Good trunk stability is essential for balance and extremity use during daily functional activities and higher-level tasks. The anticipatory activity of trunk muscles is impaired in stroke patients. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- core strengthening exercises and Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 22 Mar 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke patients (6 months to 2 years).
- Participants with first ever ischemic stroke of right or left half of the body.
- Participants should be able to walk without support for 10 m.
- MMSE score is ≥ 24.
Who cannot join
- Participants with recurrent stroke; brainstem or cerebellar stroke or hemorrhagic stroke will be excluded.
- Patients with speech problem after stroke
- Patients with other neurological disorders including: Parkinson's disease, multiple sclerosis, epilepsy, etc.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ittefaq Hospital
Lahore, Punjab Province, 54700
Ali Raza, MS(OMPT), 03326099065, araza.frahs@riphah.edu.pk
Muhammad Hanif, MsPT(NMPT)
About this study
Official title: Comparative Effects of Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques on Trunk Function and Balance in Chronic Stroke Patients
Stroke is a global healthcare issue that causes increased death rates. Good trunk stability is essential for balance and extremity use during daily functional activities and higher-level tasks. The anticipatory activity of trunk muscles is impaired in stroke patients. The trunk is the central column of the body; therefore, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional activities. The purpose of the study is to highlight the most appropriate rehabilitation technique for trunk stability.
Read the detailed description
A randomized clinical trial will be performed in which 42 patients with strokes will be included. The data will be collected from Riphah Rehabilitation center Lahore and Ittefaq hospital Lahore. Consecutive sampling technique will be used to collect data. The duration of the study will be 10 months. Trunk impairment scale and berg balance scale will be used as the data collection tool. Data collection will be started after taking informed consent from all the patients. Patients will be allocated to intervention groups by randomization. The patients in group A will be given core strengthening exercise for 4 weeks. The patient in group B will be given PNF exercise for the treatment of trunk for 4 weeks. After data collection analysis of pre and post values will be done by using SPSS version 25.
- Conditions
- Stroke
- Being tested
- core strengthening exercises, Proprioceptive Neuromuscular Facilitation
- Keywords
- Proprioceptive Neuromuscular Facilitation; Stroke
- 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
The core muscles training includes transverse abdominis, multifidus, paraspinals, quadratus lumborum, and obliques.
Proprioceptive Neuromuscular FacilitationOther
lower limb PNF technique along with conventional treatment i.e., Rhythmic initiation, slow reversal, stabilizing reversal, and combination of isotones.
| Study group | Role | What they receive |
|---|---|---|
| core strengthening exercises | Experimental | Participants will be positioned in supine.
* first stage participants will be taught to activate abdominal wall musculature. They will be initially trained to perform abdominal bracing.
* Then positioned in quadruped position and asked to lift alternate arms, gradually progressing to alternate leg lifts and alternate arm/leg raises to activate multifidus.
* Then side bridges (side plank) exercise for activation of quadratus lumborum and obliques.
* Then asked to perform trunk curls in crook lying, asking them to lift their upper trunk slightly (15°) from the plinth, hold the position for 5 sec.
* Perform 30 repetitions of each exercise with 8-sec hold.
* Maintain normal diaphragmatic breathing throughout the intervention Receives: Other: core strengthening exercises |
| Proprioceptive Neuromuscular Facilitation | Experimental | * Rhythmic initiation (RI) Patients progressively performed voluntary relaxation, passive movements, active assisted, active resisted movements and than active movements.
* Dynamic reversals (slow reversals) Isotonic contractions of first agonists and then antagonists performed against resistance was performed initially.
* Stabilizing reversals Isotonic contractions of first agonists, then antagonists against resistance was performed in an alternate way.
* Mixture of isotonic (agonist reversals, AR) resisted concentric, contraction of agonist muscles moving with the range was performed progressively following eccentric, lengthening contraction, moving slowing to the start position. .
Total 30 min for 3 days a week for a total duration of 4 weeks was set as a optimal time frame duration. Each technique was given for 10 min. Receives: Other: Proprioceptive Neuromuscular Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
Changes from baseline Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Measured: 4th week
Trunk Impairment Scale (TIS)
Changes from baseline TIS is a new tool to measure motor impairment of the trunk after stroke. The TIS evaluates static and dynamic sitting balance as well as co-ordination of trunk movement.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2023
- Primary completion15 Mar 2023 (estimated)
- Study completion22 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, MS(OMPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707065
- Sponsor's protocol ID
- REC/RCR&AHS/22/0217
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.
PubMed 28503533Park SE, Moon SH. Effects of trunk stability exercise using proprioceptive neuromuscular facilitation with changes in chair height on the gait of patients who had a stroke. J Phys Ther Sci. 2016 Jul;28(7):2014-8. doi: 10.1589/jpts.28.2014. Epub 2016 Jul 29.
PubMed 27512254Suh JH, Lee EC, Kim JS, Yoon SY. Association between trunk core muscle thickness and functional ability in subacute hemiplegic stroke patients: an exploratory cross-sectional study. Top Stroke Rehabil. 2022 Apr;29(3):163-172. doi: 10.1080/10749357.2021.1918840. Epub 2021 Apr 26.
PubMed 33899701Asghar M, Fatima A, Warner S, Khan MHU, Ahmad A, Siddique K. Effectiveness of proprioceptive neuromuscular facilitation on balance in chronic stroke patients. Rawal Medical Journal. 2021;46(1):212-5
Krukowska J, Bugajski M, Sienkiewicz M, Czernicki J. The influence of NDT-Bobath and PNF methods on the field support and total path length measure foot pressure (COP) in patients after stroke. Neurol Neurochir Pol. 2016 Nov-Dec;50(6):449-454. doi: 10.1016/j.pjnns.2016.08.004. Epub 2016 Aug 20.
PubMed 27585746
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques on Trunk Function and Balance in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05707065
- Acronym / sponsor ID
- REC/RCR&AHS/22/0217
- Conditions
- Stroke
- Keywords
- Proprioceptive Neuromuscular Facilitation; Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 22 Mar 2023 (estimated)
- First posted
- 31 Jan 2023 (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 global healthcare issue that causes increased death rates. Good trunk stability is essential for balance and extremity use during daily functional activities and higher-level tasks. The anticipatory activity of trunk muscles is impaired in stroke patients. The trunk is the central column of the body; therefore, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional activities. The purpose of the study is to highlight the most appropriate rehabilitation technique for trunk stability.
Detailed description
A randomized clinical trial will be performed in which 42 patients with strokes will be included. The data will be collected from Riphah Rehabilitation center Lahore and Ittefaq hospital Lahore. Consecutive sampling technique will be used to collect data. The duration of the study will be 10 months. Trunk impairment scale and berg balance scale will be used as the data collection tool. Data collection will be started after taking informed consent from all the patients. Patients will be allocated to intervention groups by randomization. The patients in group A will be given core strengthening exercise for 4 weeks. The patient in group B will be given PNF exercise for the treatment of trunk for 4 weeks. After data collection analysis of pre and post values will be done by using SPSS version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core strengthening exercises | Experimental | Other: core strengthening exercisesParticipants will be positioned in supine. * first stage participants will be taught to activate abdominal wall musculature. They will be initially trained to perform abdominal bracing. * Then positioned in quadruped position and asked to lift alternate arms, gradually progressing to alternate leg lifts and alternate arm/leg raises to activate multifidus. * Then side bridges (side plank) exercise for activation of quadratus lumborum and obliques. * Then asked to perform trunk curls in crook lying, asking them to lift their upper trunk slightly (15°) from the plinth, hold the position for 5 sec. * Perform 30 repetitions of each exercise with 8-sec hold. * Maintain normal diaphragmatic breathing throughout the intervention |
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Proprioceptive Neuromuscular Facilitation* Rhythmic initiation (RI) Patients progressively performed voluntary relaxation, passive movements, active assisted, active resisted movements and than active movements. * Dynamic reversals (slow reversals) Isotonic contractions of first agonists and then antagonists performed against resistance was performed initially. * Stabilizing reversals Isotonic contractions of first agonists, then antagonists against resistance was performed in an alternate way. * Mixture of isotonic (agonist reversals, AR) resisted concentric, contraction of agonist muscles moving with the range was performed progressively following eccentric, lengthening contraction, moving slowing to the start position. . Total 30 min for 3 days a week for a total duration of 4 weeks was set as a optimal time frame duration. Each technique was given for 10 min. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke patients (6 months to 2 years).
- Participants with first ever ischemic stroke of right or left half of the body.
- Participants should be able to walk without support for 10 m.
- MMSE score is ≥ 24.
Key exclusion criteria (3 listed)
- Participants with recurrent stroke; brainstem or cerebellar stroke or hemorrhagic stroke will be excluded.
- Patients with speech problem after stroke
- Patients with other neurological disorders including: Parkinson's disease, multiple sclerosis, epilepsy, etc.
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 exercisesThe core muscles training includes transverse abdominis, multifidus, paraspinals, quadratus lumborum, and obliques. | Other | core strengthening exercises |
| Proprioceptive Neuromuscular Facilitationlower limb PNF technique along with conventional treatment i.e., Rhythmic initiation, slow reversal, stabilizing reversal, and combination of isotones. | Other | Proprioceptive Neuromuscular Facilitation |
Primary outcome
Berg balance scale
Time frame: 4th week
Changes from baseline Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Trunk Impairment Scale (TIS)
Time frame: 4th week
Changes from baseline TIS is a new tool to measure motor impairment of the trunk after stroke. The TIS evaluates static and dynamic sitting balance as well as co-ordination of trunk movement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 28503533Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.
- Background: PubMed 27512254Park SE, Moon SH. Effects of trunk stability exercise using proprioceptive neuromuscular facilitation with changes in chair height on the gait of patients who had a stroke. J Phys Ther Sci. 2016 Jul;28(7):2014-8. doi: 10.1589/jpts.28.2014. Epub 2016 Jul 29.
- Background: PubMed 33899701Suh JH, Lee EC, Kim JS, Yoon SY. Association between trunk core muscle thickness and functional ability in subacute hemiplegic stroke patients: an exploratory cross-sectional study. Top Stroke Rehabil. 2022 Apr;29(3):163-172. doi: 10.1080/10749357.2021.1918840. Epub 2021 Apr 26.
- BackgroundAsghar M, Fatima A, Warner S, Khan MHU, Ahmad A, Siddique K. Effectiveness of proprioceptive neuromuscular facilitation on balance in chronic stroke patients. Rawal Medical Journal. 2021;46(1):212-5
- Background: PubMed 27585746Krukowska J, Bugajski M, Sienkiewicz M, Czernicki J. The influence of NDT-Bobath and PNF methods on the field support and total path length measure foot pressure (COP) in patients after stroke. Neurol Neurochir Pol. 2016 Nov-Dec;50(6):449-454. doi: 10.1016/j.pjnns.2016.08.004. Epub 2016 Aug 20.
- 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.
Ali Raza, MS(OMPT) principal investigator
Riphah International University
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 Proprioceptive Neuromuscular Facilitation in people with Stroke, run by Riphah International 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 4 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 31 Jan 2023. 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 Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg balance scale (time frame: 4th week). 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?
On the ClinicalTrials.gov record for NCT05707065, which also lists 5 linked publications.
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 31 Jan 2023.