NCT04816422

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 24, 2021

Last Update Submit

March 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    2 months

Study Arms (2)

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.

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.

Other: Conventional treatment

Interventions

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.

Proprioceptive neuromuscular facilitation

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.

Conventional treatment

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke (Acute stage)
  • First attack without any prior residual impairment.
  • Middle Cerebral Artery syndrome

You may not qualify if:

  • Cognitive deficits or aphasia
  • Neurological disorders e.g, Parkinson's disease.
  • Heart failure
  • Systemic orthopaedic and psychological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 29233831BACKGROUND
  • 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.

    PMID: 31621252BACKGROUND
  • 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.

    PMID: 27585746BACKGROUND
  • 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.

    PMID: 28503533BACKGROUND
  • 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.

    PMID: 31384139BACKGROUND
  • 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.

    PMID: 30067555BACKGROUND
  • 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.

    PMID: 32250337BACKGROUND
  • 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.

    PMID: 31563380BACKGROUND
  • 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.

    PMID: 29037625BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 25, 2021

Study Start

March 15, 2019

Primary Completion

September 20, 2020

Study Completion

November 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations