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

NCT06459388 | Recruiting

• 1 other identifier: REC/RCR & AHS/23/0276
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Stabilizing Reversals and Rhythmic Stabilization

EXPERIMENTAL

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

Other: Stabilizing Reversals and Rhythmic Stabilization

Pelvic Proprioceptive Neuromuscular Facilitation

EXPERIMENTAL

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.

Other: Pelvic Proprioceptive Neuromuscular Facilitation

Interventions

Stabilizing Reversals and Rhythmic Stabilization OTHER

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

Stabilizing Reversals and Rhythmic Stabilization

Pelvic Proprioceptive Neuromuscular Facilitation 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.

Pelvic Proprioceptive Neuromuscular Facilitation

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 54600, Pakistan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wajiha Shahid, Phd*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)