MedDataX Logo

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

NCT ID: NCT06459388

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Ischemic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stabilizing Reversals and Rhythmic Stabilization

This group 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 Type EXPERIMENTAL

Stabilizing Reversals and Rhythmic Stabilization

Intervention Type OTHER

3 sets with 15 repetitions in each session, 5 days per week for 8 weeks.

Pelvic Proprioceptive Neuromuscular Facilitation

This group 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.

Group Type EXPERIMENTAL

Pelvic Proprioceptive Neuromuscular Facilitation

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stabilizing Reversals and Rhythmic Stabilization

3 sets with 15 repetitions in each session, 5 days per week for 8 weeks.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riphah International University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Wajiha Shahid, Phd*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Lahore General Hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Imran Amjad, Phd

Role: CONTACT

Phone: 03324390125

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wajiha shahid, Phd*

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REC/RCR & AHS/23/0276

Identifier Type: -

Identifier Source: org_study_id