StrokeNCT04816422
PNF Techniques to Improve Bed Mobility, Transfer and Early Trunk Control in Stroke Patients
A study testing Proprioceptive neuromuscular facilitation and Conventional treatment in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Trunk control is an important factor which is disturbed after the stroke. The literature reviews suggest that trunk exercises are required to achieve good trunk stability which is essential for balance, daily functional activities and higher function tasks. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Proprioceptive neuromuscular facilitation and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2019to 30 Nov 2020
- 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
- Stroke (Acute stage)
- First attack without any prior residual impairment.
- Middle Cerebral Artery syndrome
Who cannot join
- Cognitive deficits or aphasia
- Neurological disorders e.g, Parkinson's disease.
- Heart failure
- Systemic orthopaedic and psychological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proprioceptive Neuromuscular Facilitation (PNF) Techniques to Improve Bed Mobility, Transfer and Early Trunk Control in Stroke Patients
Trunk control is an important factor which is disturbed after the stroke. The literature reviews suggest that trunk exercises are required to achieve good trunk stability which is essential for balance, daily functional activities and higher function tasks. By keeping these facts in view present study aims at evaluating the efficacy of PNF techniques \& conventional trunk exercise to improve trunk control in recovery stage hemiplegic patients Objective: To determine Proprioceptive neuromuscular facilitation (PNF) Techniques to improve bed mobility, transfer and early trunk control in Stroke patients
Read the detailed description
50 patients was included and allocated into 2 groups, group A consisting of 25 patients who received PNF techniques for trunk to improve trunk control. Group B consisting of 25 patients who received conventional trunk exercises to improve trunk control. Trunk control was assessed pre and post treatment with the help of Trunk Impairment Scale and ICU mobility scale. Data was collected by ICU mobility scale \& Trunk impairment scale
- Conditions
- Stroke
- Being tested
- Proprioceptive neuromuscular facilitation, Conventional treatment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive neuromuscular facilitationOther
rocedure
- Bilateral upper extremity pattern for trunk by Chopping, Lifting
- Bilateral lower extremity pattern for trunk.
- Trunk lateral flexion.
- Combination patterns for the trunk by Upper and lower trunk flexion, Upper trunk flexion with lower trunk extension, Upper and lower trunk extension, Upper trunk extension with lower trunk flexion.
Conventional treatmentOther
Group 2 has received conventional trunk exercise program for 45 min/day, 4 days
/ week for the period of 4 weeks the intervention includes static and dynamic functional trunk movement and strengthening exercise to the trunk muscles which includes motor developmental patterns, basic trunk movement, trunk-arm linked movements, trunk-leg linked patterns in sitting, transfer activities, with 2 minutes rest in between the repetition of each set, Progression will be made by increasing the repetition and resistance According to individual ability.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive neuromuscular facilitation | Experimental | Bilateral upper extremity pattern for trunk by Chopping, Lifting 2. Bilateral lower extremity pattern for trunk. 3. Trunk lateral flexion. 4. Combination patterns for the trunk by Upper and lower trunk flexion, Upper trunk flexion with lower trunk extension, Upper and lower trunk extension, Upper trunk extension with lower trunk flexion. Receives: Other: Proprioceptive neuromuscular facilitation |
| Conventional treatment | Active comparator | Procedure Group 2 has received conventional trunk exercise program for 45 min/day, 4 days
/ week for the period of 4 weeks the intervention includes static and dynamic functional trunk movement and strengthening exercise to the trunk muscles which includes motor developmental patterns, basic trunk movement, trunk-arm linked movements, trunk-leg linked patterns in sitting, transfer activities, with 2 minutes rest in between the repetition of each set, Progression will be made by increasing the repetition and resistance According to individual ability. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mobility scale
The ICU Mobility Scale (IMS) is an 11-item categorical scale that measures the highest level of functional mobility of patients within the intensive care unit (ICU) setting.
Measured: 2 months
Trunk impairment scale
To examine the clinimetric characteristics of the Trunk Impairment Scale (TIS). This newly developed scale evaluates motor impairment of the trunk after stroke. The TIS scores, on a range from 0 to 23, static and dynamic sitting balance as well as trunk co-ordination. It also aims to score the quality of trunk movement and to be a guide for treatment
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start15 Mar 2019
- Primary completion20 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PHD*, Principal investigator, Riphah international university lahore campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816422
- Sponsor's protocol ID
- REC/Lhr/19/1011 Naeem Abbas
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guiu-Tula FX, Cabanas-Valdes R, Sitja-Rabert M, Urrutia G, Gomara-Toldra N. The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol. BMJ Open. 2017 Dec 12;7(12):e016739. doi: 10.1136/bmjopen-2017-016739.
PubMed 29233831Li F, Sun Q, Shao XM, Xie JJ, Liu HB, Xu Y, Yang WD. [Electroacupuncture combined with PNF on proprioception and motor function of lower limbs in stroke patients: a randomized controlled trial]. Zhongguo Zhen Jiu. 2019 Oct 12;39(10):1034-40. doi: 10.13703/j.0255-2930.2019.10.002. Chinese.
PubMed 31621252Krukowska 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 27585746Sharma 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 28503533Junior VADS, Santos MS, Ribeiro NMDS, Maldonado IL. Combining Proprioceptive Neuromuscular Facilitation and Virtual Reality for Improving Sensorimotor Function in Stroke Survivors: A Randomized Clinical Trial. J Cent Nerv Syst Dis. 2019 Jul 25;11:1179573519863826. doi: 10.1177/1179573519863826. eCollection 2019.
PubMed 31384139Kim BR, Kang TW. The effects of proprioceptive neuromuscular facilitation lower-leg taping and treadmill training on mobility in patients with stroke. Int J Rehabil Res. 2018 Dec;41(4):343-348. doi: 10.1097/MRR.0000000000000309.
PubMed 30067555Shim J, Hwang S, Ki K, Woo Y. Effects of EMG-triggered FES during trunk pattern in PNF on balance and gait performance in persons with stroke. Restor Neurol Neurosci. 2020;38(2):141-150. doi: 10.3233/RNN-190944.
PubMed 32250337Smedes F, Giacometti da Silva L. Motor learning with the PNF-concept, an alternative to constrained induced movement therapy in a patient after a stroke; a case report. J Bodyw Mov Ther. 2019 Jul;23(3):622-627. doi: 10.1016/j.jbmt.2018.05.003. Epub 2018 May 31.
PubMed 31563380Cayco 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 29037625
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Neuromuscular Facilitation (PNF) Techniques to Improve Bed Mobility, Transfer and Early Trunk Control in Stroke Patients
- ClinicalTrials.gov ID
- NCT04816422
- Acronym / sponsor ID
- REC/Lhr/19/1011 Naeem Abbas
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 25 Mar 2021 (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.
Trunk control is an important factor which is disturbed after the stroke. The literature reviews suggest that trunk exercises are required to achieve good trunk stability which is essential for balance, daily functional activities and higher function tasks. By keeping these facts in view present study aims at evaluating the efficacy of PNF techniques \& conventional trunk exercise to improve trunk control in recovery stage hemiplegic patients Objective: To determine Proprioceptive neuromuscular facilitation (PNF) Techniques to improve bed mobility, transfer and early trunk control in Stroke patients
Detailed description
50 patients was included and allocated into 2 groups, group A consisting of 25 patients who received PNF techniques for trunk to improve trunk control. Group B consisting of 25 patients who received conventional trunk exercises to improve trunk control. Trunk control was assessed pre and post treatment with the help of Trunk Impairment Scale and ICU mobility scale. Data was collected by ICU mobility scale \& Trunk impairment scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive neuromuscular facilitation | Experimental | Other: Proprioceptive neuromuscular facilitationBilateral upper extremity pattern for trunk by Chopping, Lifting 2. Bilateral lower extremity pattern for trunk. 3. Trunk lateral flexion. 4. Combination patterns for the trunk by Upper and lower trunk flexion, Upper trunk flexion with lower trunk extension, Upper and lower trunk extension, Upper trunk extension with lower trunk flexion. |
| Conventional treatment | Active comparator | Other: Conventional treatmentProcedure Group 2 has received conventional trunk exercise program for 45 min/day, 4 days / week for the period of 4 weeks the intervention includes static and dynamic functional trunk movement and strengthening exercise to the trunk muscles which includes motor developmental patterns, basic trunk movement, trunk-arm linked movements, trunk-leg linked patterns in sitting, transfer activities, with 2 minutes rest in between the repetition of each set, Progression will be made by increasing the repetition and resistance According to individual ability. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stroke (Acute stage)
- First attack without any prior residual impairment.
- Middle Cerebral Artery syndrome
Key exclusion criteria (4 listed)
- Cognitive deficits or aphasia
- Neurological disorders e.g, Parkinson's disease.
- Heart failure
- Systemic orthopaedic and psychological disorders
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 |
|---|---|---|
| Proprioceptive neuromuscular facilitationrocedure 1. Bilateral upper extremity pattern for trunk by Chopping, Lifting 2. Bilateral lower extremity pattern for trunk. 3. Trunk lateral flexion. 4. Combination patterns for the trunk by Upper and lower trunk flexion, Upper trunk flexion with lower trunk extension, Upper and lower trunk extension, Upper trunk extension with lower trunk flexion. | Other | Proprioceptive neuromuscular facilitation |
| Conventional treatmentGroup 2 has received conventional trunk exercise program for 45 min/day, 4 days / week for the period of 4 weeks the intervention includes static and dynamic functional trunk movement and strengthening exercise to the trunk muscles which includes motor developmental patterns, basic trunk movement, trunk-arm linked movements, trunk-leg linked patterns in sitting, transfer activities, with 2 minutes rest in between the repetition of each set, Progression will be made by increasing the repetition and resistance According to individual ability. | Other | Conventional treatment |
Primary outcome
ICU mobility scale
Time frame: 2 months
The ICU Mobility Scale (IMS) is an 11-item categorical scale that measures the highest level of functional mobility of patients within the intensive care unit (ICU) setting.
Trunk impairment scale
Time frame: 2 months
To examine the clinimetric characteristics of the Trunk Impairment Scale (TIS). This newly developed scale evaluates motor impairment of the trunk after stroke. The TIS scores, on a range from 0 to 23, static and dynamic sitting balance as well as trunk co-ordination. It also aims to score the quality of trunk movement and to be a guide for treatment
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 30 Mar 2021.
- Background: PubMed 29233831Guiu-Tula FX, Cabanas-Valdes R, Sitja-Rabert M, Urrutia G, Gomara-Toldra N. The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol. BMJ Open. 2017 Dec 12;7(12):e016739. doi: 10.1136/bmjopen-2017-016739.
- Background: PubMed 31621252Li F, Sun Q, Shao XM, Xie JJ, Liu HB, Xu Y, Yang WD. [Electroacupuncture combined with PNF on proprioception and motor function of lower limbs in stroke patients: a randomized controlled trial]. Zhongguo Zhen Jiu. 2019 Oct 12;39(10):1034-40. doi: 10.13703/j.0255-2930.2019.10.002. Chinese.
- 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.
- 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 31384139Junior VADS, Santos MS, Ribeiro NMDS, Maldonado IL. Combining Proprioceptive Neuromuscular Facilitation and Virtual Reality for Improving Sensorimotor Function in Stroke Survivors: A Randomized Clinical Trial. J Cent Nerv Syst Dis. 2019 Jul 25;11:1179573519863826. doi: 10.1177/1179573519863826. eCollection 2019.
- Background: PubMed 30067555Kim BR, Kang TW. The effects of proprioceptive neuromuscular facilitation lower-leg taping and treadmill training on mobility in patients with stroke. Int J Rehabil Res. 2018 Dec;41(4):343-348. doi: 10.1097/MRR.0000000000000309.
- Background: PubMed 32250337Shim J, Hwang S, Ki K, Woo Y. Effects of EMG-triggered FES during trunk pattern in PNF on balance and gait performance in persons with stroke. Restor Neurol Neurosci. 2020;38(2):141-150. doi: 10.3233/RNN-190944.
- Background: PubMed 31563380Smedes F, Giacometti da Silva L. Motor learning with the PNF-concept, an alternative to constrained induced movement therapy in a patient after a stroke; a case report. J Bodyw Mov Ther. 2019 Jul;23(3):622-627. doi: 10.1016/j.jbmt.2018.05.003. Epub 2018 May 31.
- 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.
- 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.
Binash Afzal, PHD* principal investigator
Riphah international university lahore campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive neuromuscular facilitation and Conventional treatment 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 3 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: finished, as of the sponsor's last update on 30 Mar 2021. 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?
ICU mobility scale (time frame: 2 months). 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 NCT04816422, which also lists 9 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 30 Mar 2021.