Clinical trial NCT06459388: Stabilizing Reversal and Rhythmic Stabilization vs Pelvic Proprioceptive Neuromuscular Facilitation in Stroke Patients
Official title: Effects of Stabilizing Reversal and Rhythmic Stabilization Versus Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control, Postural Stability and Mobility in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Trunk Impairment Scale
timeFrame: 0 week, 4th week, 8th week
measure: Postural Assessment Scale
timeFrame: 0 week, 4th week, 8th week
measure: Functional Reach Test
timeFrame: 0 week, 4th week, 8th week
measure: Performance Oriented Mobility Assessment
timeFrame: 0 week, 4th week, 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lahore General Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Wajiha Shahid, Phd*
role: PRINCIPAL_INVESTIGATOR
References: