AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Pakistan1 site
  • Binash afzal

    Lahore, Punjab Province, 54000

Other trials in Pakistan

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

    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.
  • 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 groups in NCT04816422
Study groupRoleWhat they receive
Proprioceptive neuromuscular facilitationExperimentalBilateral 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 treatmentActive comparatorProcedure 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.

  1. 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

  2. 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.

  1. First posted25 Mar 2021
  2. Study start15 Mar 2019
  3. Primary completion20 Sep 2020
  4. Study completion30 Nov 2020

Resources

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)
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 29233831
  • Li 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 31621252
  • 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
  • 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 28503533
  • Junior 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 31384139
  • Kim 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 30067555
  • Shim 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 32250337
  • Smedes 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 31563380
  • Cayco 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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in