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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05707065
Other study ID # REC/RCR&AHS/22/0217
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date March 22, 2023

Study information

Verified date January 2023
Source Riphah International University
Contact Imran Amjad, Phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date March 22, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
core strengthening exercises
The core muscles training includes transverse abdominis, multifidus, paraspinals, quadratus lumborum, and obliques.
Proprioceptive Neuromuscular Facilitation
lower limb PNF technique along with conventional treatment i.e., Rhythmic initiation, slow reversal, stabilizing reversal, and combination of isotones.

Locations

Country Name City State
Pakistan Ittefaq Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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