Stroke, IschemicNCT06459388
Stabilizing Reversal and Rhythmic Stabilization vs Pelvic Proprioceptive Neuromuscular Facilitation in Stroke Patients
A study testing Stabilizing Reversals and Rhythmic Stabilization and Pelvic Proprioceptive Neuromuscular Facilitation in people with Stroke, Ischemic, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Stabilizing Reversals and Rhythmic Stabilization and Pelvic Proprioceptive Neuromuscular Facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Lahore General Hospital
Lahore, Punjab Province, 54600
Wajiha shahid, Phd*, wajiha.shahid@riphah.edu.pk
Amber Shahzadi, MsPT (NMPT)
About this study
Official title: Effects of Stabilizing Reversal and Rhythmic Stabilization Versus Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control, Postural Stability and Mobility in Stroke Patients
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?
Read more
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.
Read the 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.
- Conditions
- Stroke, Ischemic
- Being tested
- Stabilizing Reversals and Rhythmic Stabilization, Pelvic Proprioceptive Neuromuscular Facilitation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilizing Reversals and Rhythmic StabilizationOther
3 sets with 15 repetitions in each session, 5 days per week for 8 weeks.
Pelvic Proprioceptive Neuromuscular FacilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Pelvic Proprioceptive Neuromuscular Facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0 week, 4th week, 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 May 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wajiha Shahid, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459388
- Sponsor's protocol ID
- REC/RCR & AHS/23/0276
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stabilizing Reversal and Rhythmic Stabilization Versus Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control, Postural Stability and Mobility in Stroke Patients
- ClinicalTrials.gov ID
- NCT06459388
- Acronym / sponsor ID
- REC/RCR & AHS/23/0276
- Conditions
- Stroke, Ischemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilizing Reversals and Rhythmic Stabilization | Experimental | Other: Stabilizing Reversals and Rhythmic StabilizationThis 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 |
| Pelvic Proprioceptive Neuromuscular Facilitation | Experimental | Other: Pelvic Proprioceptive Neuromuscular FacilitationThis 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilizing Reversals and Rhythmic Stabilization3 sets with 15 repetitions in each session, 5 days per week for 8 weeks. | Other | Stabilizing Reversals and Rhythmic Stabilization |
| Pelvic Proprioceptive Neuromuscular FacilitationThe 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 |
Primary outcome
Trunk Impairment Scale
Time frame: 0 week, 4th week, 8th week
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.
Postural Assessment Scale
Time frame: 0 week, 4th week, 8th week
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.
Functional Reach Test
Time frame: 0 week, 4th week, 8th week
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.
Performance Oriented Mobility Assessment
Time frame: 0 week, 4th week, 8th week
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wajiha Shahid, Phd* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilizing Reversals and Rhythmic Stabilization and Pelvic Proprioceptive Neuromuscular Facilitation in people with Stroke, Ischemic, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (time frame: 0 week, 4th week, 8th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.