NCT05707065

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 22, 2023

Last Update Submit

January 30, 2023

Conditions

Keywords

Proprioceptive Neuromuscular Facilitation; Stroke

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    4th week

Study Arms (2)

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

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.

Other: Proprioceptive Neuromuscular Facilitation

Interventions

The core muscles training includes transverse abdominis, multifidus, paraspinals, quadratus lumborum, and obliques.

core strengthening exercises

lower limb PNF technique along with conventional treatment i.e., Rhythmic initiation, slow reversal, stabilizing reversal, and combination of isotones.

Proprioceptive Neuromuscular Facilitation

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ittefaq Hospital

Lahore, Punjab Province, 54700, Pakistan

RECRUITING

Related Publications (5)

  • 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
  • Park 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.

    PMID: 27512254BACKGROUND
  • Suh 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.

    PMID: 33899701BACKGROUND
  • Asghar 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
  • 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

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

  • Ali Raza, MS(OMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

January 22, 2023

First Posted

January 31, 2023

Study Start

January 1, 2023

Primary Completion

March 15, 2023

Study Completion

March 22, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations