Stabilizing Reversal and Rhythmic Stabilization vs Pelvic Proprioceptive Neuromuscular Facilitation in Stroke Patients

Stroke, Ischemic Clinical Trial

Official title:

Effects of Stabilizing Reversal and Rhythmic Stabilization Versus Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control, Postural Stability and Mobility in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459388
• Other study ID #: REC/RCR & AHS/23/0276
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effects of stabilizing reversal and rhythmic stabilization versus pelvic proprioceptive neuromuscular facilitation on trunk control, postural stability and mobility in stroke patients. The main question it aims to answer is: Is there any difference in effects of stabilizing reversal and rhythmic stabilization versus pelvic proprioceptive neuromuscular facilitation on trunk control, postural stability and mobility in stroke patients? Researchers will compare stabilizing reversal and rhythmic stabilization to pelvic proprioceptive neuromuscular facilitation to see if there any difference in effects of stabilizing reversal and rhythmic stabilization versus pelvic proprioceptive neuromuscular facilitation on trunk control, postural stability and mobility in stroke patient. Participants will be divided into two groups: Group A will receive stabilizing reversals and rhythmic reversals technique. The patient will perform 3 sets with 15 repetitions in each session, 5 days per week for 8 weeks. Group B will receive Pelvic PNF protocol. The treatment protocol will be followed 5 days a week for 8 weeks (i.e. 20 sessions) and each session will last for 30 minutes.

Description:

It will be a randomized clinical trial study in which non-probability convenience sampling will be used. The sample size will be 50. The participants fulfilling the inclusion criteria will be divided randomly into two groups through computerized table generator method of randomization. Baseline assessment of both groups will be done before the execution of interventions. Group A will receive stabilizing reversal and rhythmic stabilization protocols for 5 days per week for 8 weeks. Group B will receive pelvic PNF protocol 5 days per week for 8 weeks. Trunk Impairment scale will be used to assess trunk control, Postural assessment Scale and Functional Reach Test will be used to assess postural stability and Performance Oriented Mobility Assessment will measure the mobility at the baseline, at 4 weeks and after the completion of intervention at 8 weeks to find out the outcome measures of the participants. The data will be analyzed using SPSS version 24. Normality of data will be assessed through Kolmogorov-smirnov test. Difference between preintervention, mid-intervention and post-intervention readings will be calculated using repeated measure ANOVA for parametric data. For non-parametric data Kruskal Wallis test will be used. For between group analysis Independent sample t test will be used for parametric data and Mann Whitney test will be used for non-parametric data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosed cases of ischemic stroke.
• Both genders of stroke patients.
• Age of stroke patients between 40-65 years.
• Duration of stroke less than 6 months.
• Participants should be able to understand and follow simple verbal commands (MMSE
• 24).

Exclusion Criteria:

• Recurrent history of stroke.
• Recent history of any trauma.
• Musculoskeletal disorders such as low back pain, arthritis, degenerative diseases of the lower limbs affecting motor performance, spinal deformity and contractures.
• Spasticity (modified Ashworth scale grade =3) or flaccidity in lower limbs and upper limbs.
• PNF treatment given to the pelvic region within 6 weeks.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• Stabilizing Reversals and Rhythmic Stabilization
3 sets with 15 repetitions in each session, 5 days per week for 8 weeks.
• Pelvic Proprioceptive Neuromuscular Facilitation
The treatment protocol will be followed 5 days a week for 8 weeks (i.e. 20 sessions) and each session will last for 30 minutes.

Locations

Country	Name	City	State
Pakistan	Lahore General Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk Impairment Scale	TIS assesses static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points. The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance. Test/retest and inter observer reliability for the TIS total score (ICC) - 0.96 and 0.99, respectively.	0 week, 4th week, 8th week
Primary	Postural Assessment Scale	Postural assessment scale assess and monitor postural control after stroke. It contains 12 four-level items of varying difficulty for assessing ability to maintain or change a given lying, sitting or standing posture. The PASS consists of 2 sections (maintaining posture and changing a posture) with a 4-point scale (0 indicating no performance and 3 indicating maximum performance) to describe each task. The total score ranges from 0 - 36.	0 week, 4th week, 8th week
Primary	Functional Reach Test	Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. Measurements are interpreted as: 10"/25 cm or greater Low risk of falls, 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal, 6"/15cm or less Risk of falling is 4x greater than normal unwilling to reach Risk of falling is 8x greater than normal.	0 week, 4th week, 8th week
Primary	Performance Oriented Mobility Assessment	Performance oriented mobility assessment assesses a person's perception of balance and stability during activities of daily living and their fear of falling. The POMA test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totaling 28. The lower the score on the POMA test, the higher the risk of falling. 25-28 = low fall risk, 19-24 = medium fall risk, < 19 = high fall risk.	0 week, 4th week, 8th week