Back to resultsCore Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques in Chronic Stroke Patients
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
core strengthening exercises
Proprioceptive Neuromuscular Facilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Proprioceptive Neuromuscular Facilitation; Stroke
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Ittefaq HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
core strengthening exercises
Proprioceptive Neuromuscular Facilitation
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05707065
First Posted
January 22, 2023
Last Updated
January 30, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05707065
Brief Title
Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques in Chronic Stroke Patients
Official Title
Comparative Effects of Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques on Trunk Function and Balance in Chronic Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
A randomized clinical trial will be performed in which 42 patients with strokes will be included. The data will be collected from Riphah Rehabilitation center Lahore and Ittefaq hospital Lahore. Consecutive sampling technique will be used to collect data. The duration of the study will be 10 months. Trunk impairment scale and berg balance scale will be used as the data collection tool. Data collection will be started after taking informed consent from all the patients. Patients will be allocated to intervention groups by randomization. The patients in group A will be given core strengthening exercise for 4 weeks. The patient in group B will be given PNF exercise for the treatment of trunk for 4 weeks. After data collection analysis of pre and post values will be done by using SPSS version 25.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Proprioceptive Neuromuscular Facilitation; Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
core strengthening exercises
Arm Type
Experimental
Arm Description
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
Arm Title
Proprioceptive Neuromuscular Facilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
core strengthening exercises
Intervention Description
The core muscles training includes transverse abdominis, multifidus, paraspinals, quadratus lumborum, and obliques.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Neuromuscular Facilitation
Intervention Description
lower limb PNF technique along with conventional treatment i.e., Rhythmic initiation, slow reversal, stabilizing reversal, and combination of isotones.
Primary Outcome Measure Information:
Title
Berg balance scale
Description
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.
Time Frame
4th week
Title
Trunk Impairment Scale (TIS)
Description
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.
Time Frame
4th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Raza, MS(OMPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ittefaq Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Raza, MS(OMPT)
Phone
03326099065
Email
araza.frahs@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Muhammad Hanif, MsPT(NMPT)
First Name & Middle Initial & Last Name & Degree
Ali Raza, Ms(OMPT)
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28503533
Citation
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.
Results Reference
background
PubMed Identifier
27512254
Citation
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.
Results Reference
background
PubMed Identifier
33899701
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
27585746
Citation
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.
Results Reference
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Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques in Chronic Stroke Patients
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