StrokeNCT05856045
PNF vs Pertubation Based Balance Training in Subacute Stroke Patients.
A study testing PNF(proprioceptive neuromuscular facilitation exercises), PBBT (pertubation based balance training) and PNF and PBBT intervention group in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients, it will be a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- PNF(proprioceptive neuromuscular facilitation exercises), PBBT (pertubation based balance training) and PNF and PBBT intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2023to 30 Oct 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:40-70 years.
- Gender: Male and female
- The Subacute stroke patients, at least 3 months post stroke.
- Patients able to stand without support from upper limb.
- Patients able to perform 10 meter walk test.
Who cannot join
- Neurological conditions other than stroke like Guillain barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Parkinson's disease, Transverse Myelitis etc.
- Patients with not intact higher mental function and cognition.
- Patients with grade 3 arthritis and traumatic injuries like spinal cord injuries and TBIs
- Other chronic disabling pathologies, orthopedic injuries that could impair locomotion
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Services Hospital
Lahore, Punjab Province, 54770
hira jabeen, 03234116506, hira.jabeen@riphah.edu.pk
nimra azmat, MSNMPT
About this study
Official title: Effects of Proprioceptive Neuromuscular Facilitation Exercises Versus Perturbation-based Balance Training on Balance, Coordination and Proprioception in Subacute Stroke Patients
To determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients, it will be a randomized clinical trial.
Read the detailed description
Stroke is the major cause of disability and mortality worldwide. Stroke is defined as an abrupt neurological outburst caused by impaired perfusion through the blood vessels to the brain. Every year the number of strokes affected individuals are rising thereby putting an extra pressure on socioeconomic conditions in developing countries. Major complications of stroke include hemiplegia leading to upper limb dysfunction along with gait abnormalities. This study will be conducted to determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients. The randomized clinical trial will be conducted, participants will be selected through Non probability convenience sampling technique and then randomly allocated into three treatment groups.
- Conditions
- Stroke
- Being tested
- PNF(proprioceptive neuromuscular facilitation exercises), PBBT (pertubation based balance training), PNF and PBBT intervention group
- Keywords
- hemiplegia, cardiovascular accident, pnf, PBBT (pertubation based balance training)
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF(proprioceptive neuromuscular facilitation exercises)Other
PNF involves both stretching and contracting (activation) of the muscle group being targeted in order to achieve maximum static flexibility, along with its D1\&D2 flexion/extension patterns to improve dynamic flexibility and thus improving balance and coordination.
total 8 weeks session was given to patients. 45 mins session/each day for 6 days a week.
PBBT (pertubation based balance training)Other
Perturbation-based balance training (PBT) is an emerging task-specific intervention that aims to improve reactive balance control after destabilizing perturbations in a safe and controlled environment. Pertubations are given by therapist in unexpected directions to challenge patients reactive balance. In this study pertubations will be given manually and on treadmill by a harness system.
daily 45 mins of exercise session of pertuations divided into double leg foam roller, wobble board exercises and pertubations on treadmill were performed for total 8 weeks and 6 days a week.
PNF and PBBT intervention groupOther
proprioceptive neuromuscular exercises, pertubation based balance training along with conventional physiotherapy exercises were given for 8 weeks and 6 days per week for around 45 mins.
| Study group | Role | What they receive |
|---|---|---|
| PNF intervention group | Experimental | Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output. Receives: Other: PNF(proprioceptive neuromuscular facilitation exercises) |
| PBBT(pertubation based balance training) intervention group | Experimental | Perturbation-based balance training (also referred to as reactive balance training or perturbation training) utilizes a task-specific approach to balance training, applying repeated exposure to unpredictable mechanical perturbations that mimic balance disturbances experienced in daily life. Receives: Other: PBBT (pertubation based balance training) |
| PNF and PBBT intervention group | Experimental | both techniques will be used Receives: Other: PNF and PBBT intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti Performance Oriented Mobility Assessment(POMA)
The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's gait and balance abilities. Equipment needed are Hard armless chair, Stopwatch or wristwatch and 15 ft walkway.it takes 10-15 minutes to administer.
total score is 28 interpretation: 25-28 = low fall risk
19-24 = medium fall risk
< 19 = high fall risk
Measured: 8th week
FMA lower extremity
The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is a widely used and recommended scale for evaluation of post-stroke motor impairment. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
The scale is comprised of five domains and there are 155 items in total
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start25 Feb 2023
- Primary completion18 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hira jabeen, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856045
- Sponsor's protocol ID
- REC/5341nimraazmat
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
PubMed 33076218GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.
PubMed 30871944Cohen AL, Ferguson MA, Fox MD. Lesion network mapping predicts post-stroke behavioural deficits and improves localization. Brain. 2021 May 7;144(4):e35. doi: 10.1093/brain/awab002. No abstract available.
PubMed 33899085Nguyen PT, Chou LW, Hsieh YL. Proprioceptive Neuromuscular Facilitation-Based Physical Therapy on the Improvement of Balance and Gait in Patients with Chronic Stroke: A Systematic Review and Meta-Analysis. Life (Basel). 2022 Jun 13;12(6):882. doi: 10.3390/life12060882.
PubMed 35743913Park J, Kim TH. The effects of balance and gait function on quality of life of stroke patients. NeuroRehabilitation. 2019;44(1):37-41. doi: 10.3233/NRE-182467.
PubMed 30741699Tyson SF, Sadeghi-Demneh E, Nester CJ. The effects of transcutaneous electrical nerve stimulation on strength, proprioception, balance and mobility in people with stroke: a randomized controlled cross-over trial. Clin Rehabil. 2013 Sep;27(9):785-91. doi: 10.1177/0269215513478227. Epub 2013 Mar 15.
PubMed 23503739Cayco CS, Gorgon EJR, Lazaro RT. Effects of proprioceptive neuromuscular facilitation on balance, strength, and mobility of an older adult with chronic stroke: A case report. J Bodyw Mov Ther. 2017 Oct;21(4):767-774. doi: 10.1016/j.jbmt.2016.10.008. Epub 2016 Oct 27.
PubMed 29037625Seo K, Park SH, Park K. The effects of stair gait training using proprioceptive neuromuscular facilitation on stroke patients' dynamic balance ability. J Phys Ther Sci. 2015 May;27(5):1459-62. doi: 10.1589/jpts.27.1459. Epub 2015 May 26.
PubMed 26157240Gunning E, Uszynski MK. Effectiveness of the Proprioceptive Neuromuscular Facilitation Method on Gait Parameters in Patients With Stroke: A Systematic Review. Arch Phys Med Rehabil. 2019 May;100(5):980-986. doi: 10.1016/j.apmr.2018.11.020. Epub 2018 Dec 22.
PubMed 30582917Handelzalts S, Kenner-Furman M, Gray G, Soroker N, Shani G, Melzer I. Effects of Perturbation-Based Balance Training in Subacute Persons With Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Mar;33(3):213-224. doi: 10.1177/1545968319829453. Epub 2019 Feb 15.
PubMed 30767613Mansfield A, Aqui A, Centen A, Danells CJ, DePaul VG, Knorr S, Schinkel-Ivy A, Brooks D, Inness EL, McIlroy WE, Mochizuki G. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. BMC Neurol. 2015 Jun 6;15:87. doi: 10.1186/s12883-015-0347-8.
PubMed 26048054Mansfield A, Schinkel-Ivy A, Danells CJ, Aqui A, Aryan R, Biasin L, DePaul VG, Inness EL. Does Perturbation Training Prevent Falls after Discharge from Stroke Rehabilitation? A Prospective Cohort Study with Historical Control. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2174-2180. doi: 10.1016/j.jstrokecerebrovasdis.2017.04.041. Epub 2017 Jun 1.
PubMed 28579506Ribeiro T, Britto H, Oliveira D, Silva E, Galvao E, Lindquist A. Effects of treadmill training with partial body weight support and the proprioceptive neuromuscular facilitation method on hemiparetic gait: a randomized controlled study. Eur J Phys Rehabil Med. 2013 Aug;49(4):451-61. Epub 2012 Nov 20.
PubMed 23172402van Duijnhoven HJR, Roelofs JMB, den Boer JJ, Lem FC, Hofman R, van Bon GEA, Geurts ACH, Weerdesteyn V. Perturbation-Based Balance Training to Improve Step Quality in the Chronic Phase After Stroke: A Proof-of-Concept Study. Front Neurol. 2018 Nov 22;9:980. doi: 10.3389/fneur.2018.00980. eCollection 2018.
PubMed 30524360Belas Dos Santos M, Barros de Oliveira C, Dos Santos A, Garabello Pires C, Dylewski V, Arida RM. A Comparative Study of Conventional Physiotherapy versus Robot-Assisted Gait Training Associated to Physiotherapy in Individuals with Ataxia after Stroke. Behav Neurol. 2018 Feb 20;2018:2892065. doi: 10.1155/2018/2892065. eCollection 2018.
PubMed 29675114
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Neuromuscular Facilitation Exercises Versus Perturbation-based Balance Training on Balance, Coordination and Proprioception in Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT05856045
- Acronym / sponsor ID
- REC/5341nimraazmat
- Conditions
- Stroke
- Keywords
- hemiplegia, cardiovascular accident, pnf, PBBT (pertubation based balance training)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 18 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 12 May 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.
To determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients, it will be a randomized clinical trial.
Detailed description
Stroke is the major cause of disability and mortality worldwide. Stroke is defined as an abrupt neurological outburst caused by impaired perfusion through the blood vessels to the brain. Every year the number of strokes affected individuals are rising thereby putting an extra pressure on socioeconomic conditions in developing countries. Major complications of stroke include hemiplegia leading to upper limb dysfunction along with gait abnormalities. This study will be conducted to determine the effects of proprioceptive neuromuscular facilitation exercises versus perturbation-based balance training on balance, coordination, and proprioception in subacute stroke patients. The randomized clinical trial will be conducted, participants will be selected through Non probability convenience sampling technique and then randomly allocated into three treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PNF intervention group | Experimental | Other: PNF(proprioceptive neuromuscular facilitation exercises)Proprioceptive neuromuscular facilitation (PNF) is a therapeutic approach that uses cutaneous, proprioceptive and auditory input to produce functional improvement in motor output. |
| PBBT(pertubation based balance training) intervention group | Experimental | Other: PBBT (pertubation based balance training)Perturbation-based balance training (also referred to as reactive balance training or perturbation training) utilizes a task-specific approach to balance training, applying repeated exposure to unpredictable mechanical perturbations that mimic balance disturbances experienced in daily life. |
| PNF and PBBT intervention group | Experimental | Other: PNF and PBBT intervention groupboth techniques will be used |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age:40-70 years.
- Gender: Male and female
- The Subacute stroke patients, at least 3 months post stroke.
- Patients able to stand without support from upper limb.
- Patients able to perform 10 meter walk test.
Key exclusion criteria (4 listed)
- Neurological conditions other than stroke like Guillain barre syndrome, Chronic inflammatory demyelinating polyradiculoneuropathy, Parkinson's disease, Transverse Myelitis etc.
- Patients with not intact higher mental function and cognition.
- Patients with grade 3 arthritis and traumatic injuries like spinal cord injuries and TBIs
- Other chronic disabling pathologies, orthopedic injuries that could impair locomotion
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 |
|---|---|---|
| PNF(proprioceptive neuromuscular facilitation exercises)PNF involves both stretching and contracting (activation) of the muscle group being targeted in order to achieve maximum static flexibility, along with its D1\&D2 flexion/extension patterns to improve dynamic flexibility and thus improving balance and coordination. total 8 weeks session was given to patients. 45 mins session/each day for 6 days a week. | Other | PNF intervention group |
| PBBT (pertubation based balance training)Perturbation-based balance training (PBT) is an emerging task-specific intervention that aims to improve reactive balance control after destabilizing perturbations in a safe and controlled environment. Pertubations are given by therapist in unexpected directions to challenge patients reactive balance. In this study pertubations will be given manually and on treadmill by a harness system. daily 45 mins of exercise session of pertuations divided into double leg foam roller, wobble board exercises and pertubations on treadmill were performed for total 8 weeks and 6 days a week. | Other | PBBT(pertubation based balance training) intervention group |
| PNF and PBBT intervention groupproprioceptive neuromuscular exercises, pertubation based balance training along with conventional physiotherapy exercises were given for 8 weeks and 6 days per week for around 45 mins. | Other | PNF and PBBT intervention group |
Primary outcome
Tinetti Performance Oriented Mobility Assessment(POMA)
Time frame: 8th week
The Tinetti assessment tool is an easily administered task-oriented test that measures an older adult's gait and balance abilities. Equipment needed are Hard armless chair, Stopwatch or wristwatch and 15 ft walkway.it takes 10-15 minutes to administer. total score is 28 interpretation: 25-28 = low fall risk 19-24 = medium fall risk < 19 = high fall risk
FMA lower extremity
Time frame: 8th week
The Fugl-Meyer Assessment of Lower Extremity (FMA-LE) is a widely used and recommended scale for evaluation of post-stroke motor impairment. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 33076218Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
- Background: PubMed 30871944GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.
- Background: PubMed 33899085Cohen AL, Ferguson MA, Fox MD. Lesion network mapping predicts post-stroke behavioural deficits and improves localization. Brain. 2021 May 7;144(4):e35. doi: 10.1093/brain/awab002. No abstract available.
- Background: PubMed 35743913Nguyen PT, Chou LW, Hsieh YL. Proprioceptive Neuromuscular Facilitation-Based Physical Therapy on the Improvement of Balance and Gait in Patients with Chronic Stroke: A Systematic Review and Meta-Analysis. Life (Basel). 2022 Jun 13;12(6):882. doi: 10.3390/life12060882.
- Background: PubMed 30741699Park J, Kim TH. The effects of balance and gait function on quality of life of stroke patients. NeuroRehabilitation. 2019;44(1):37-41. doi: 10.3233/NRE-182467.
- Background: PubMed 23503739Tyson SF, Sadeghi-Demneh E, Nester CJ. The effects of transcutaneous electrical nerve stimulation on strength, proprioception, balance and mobility in people with stroke: a randomized controlled cross-over trial. Clin Rehabil. 2013 Sep;27(9):785-91. doi: 10.1177/0269215513478227. Epub 2013 Mar 15.
- Background: PubMed 29037625Cayco CS, Gorgon EJR, Lazaro RT. Effects of proprioceptive neuromuscular facilitation on balance, strength, and mobility of an older adult with chronic stroke: A case report. J Bodyw Mov Ther. 2017 Oct;21(4):767-774. doi: 10.1016/j.jbmt.2016.10.008. Epub 2016 Oct 27.
- Background: PubMed 26157240Seo K, Park SH, Park K. The effects of stair gait training using proprioceptive neuromuscular facilitation on stroke patients' dynamic balance ability. J Phys Ther Sci. 2015 May;27(5):1459-62. doi: 10.1589/jpts.27.1459. Epub 2015 May 26.
- Background: PubMed 30582917Gunning E, Uszynski MK. Effectiveness of the Proprioceptive Neuromuscular Facilitation Method on Gait Parameters in Patients With Stroke: A Systematic Review. Arch Phys Med Rehabil. 2019 May;100(5):980-986. doi: 10.1016/j.apmr.2018.11.020. Epub 2018 Dec 22.
- Background: PubMed 30767613Handelzalts S, Kenner-Furman M, Gray G, Soroker N, Shani G, Melzer I. Effects of Perturbation-Based Balance Training in Subacute Persons With Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2019 Mar;33(3):213-224. doi: 10.1177/1545968319829453. Epub 2019 Feb 15.
- Background: PubMed 26048054Mansfield A, Aqui A, Centen A, Danells CJ, DePaul VG, Knorr S, Schinkel-Ivy A, Brooks D, Inness EL, McIlroy WE, Mochizuki G. Perturbation training to promote safe independent mobility post-stroke: study protocol for a randomized controlled trial. BMC Neurol. 2015 Jun 6;15:87. doi: 10.1186/s12883-015-0347-8.
- Background: PubMed 28579506Mansfield A, Schinkel-Ivy A, Danells CJ, Aqui A, Aryan R, Biasin L, DePaul VG, Inness EL. Does Perturbation Training Prevent Falls after Discharge from Stroke Rehabilitation? A Prospective Cohort Study with Historical Control. J Stroke Cerebrovasc Dis. 2017 Oct;26(10):2174-2180. doi: 10.1016/j.jstrokecerebrovasdis.2017.04.041. Epub 2017 Jun 1.
- 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.
hira jabeen 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 PNF(proprioceptive neuromuscular facilitation exercises), PBBT (pertubation based balance training) and PNF and PBBT intervention group 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 5 inclusion and 4 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 12 May 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 (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?
Tinetti Performance Oriented Mobility Assessment(POMA) (time frame: 8th 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 NCT05856045, which also lists 21 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 12 May 2023.