- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381491
Effects of Core Strengthening With Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control and Balance in Patients With Sub-acute Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Interventions FITT Principle Intervention was given for 60 min per session (30 + 30 mins for each group), including 3 sets with10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise (this FITT principle for core stabilization and trunk control exercises). For PNF technique each technique was applied for 3 sets of 2 min duration each with 30 sec between each set and 2 min rest after each technique.
Once a day, 5 times per week for 6 weeks for both groups. Groups There were two groups Groups 1 (interventional group) Groups 2 (control group) Groups 1 (interventional group) Participants who were included in this group got Pelvic Proprioceptive neuromuscular facilitation techniques + core strengthening group + Trunk control exercises (Conventional treatment).
Core stabilization exercises techniques Core activated by Bio Feedback apparatus and participants were given instructions to do trunk curls in crook lying position. Asked to lift their upper trunk slightly (15 degree) from the plinth. 3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
Proprioceptive neuromuscular facilitation techniques The sequence was rhythmic initiation, slow reversal then agonistic reversals. each technique was applied for 3 sets of 2 min duration each with 30 sec between each set and 2 min rest after each technique. A stopwatch was used to measure the time.
Trunk control exercises Different trunk exercises were performed by the participants to develop trunk control and balance. Rhythmic stabilization, Side-Lying Trunk Lifts, Bridging, Quadruped, Kneeling and modified plantigrade positioning, are the trunk exercises which were used conventionally to develop trunk control. 3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
Groups 2 (control group) Participants in group 2 received Core stabilization exercises + Conventional trunk control exercises (Rhythmic stabilization, Bridging, Side-Lying Trunk Lifts, Quadruped, Kneeling and modified plantigrade positioning) exercises. 3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
Core stabilization exercises techniques Core activated by Bio Feedback apparatus and participants were given instructions to do trunk curls in crook lying position. Asked to lift their upper trunk slightly (15 degree) from the plinth. 3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
Trunk control exercises Different trunk exercises were performed by the participants to develop trunk control and balance. Rhythmic stabilization, Side-Lying Trunk Lifts, Bridging, Quadruped, Kneeling and modified plantigrade positioning, are the trunk exercises which were used conventionally to develop trunk control. 3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
Outcomes Measures Trunk Impairment Scale (TIS) is a standardized scale to assess the trunk function and stability in stroke patients(39). We used the pre- and post-intervention scores of Trunk Impairment Scale (TIS) to evaluate trunk function and stability.
Berg Balance Scale (BBS) is identified as the most commonly used as an evaluation tool in the stroke rehabilitation(40). We used the pre- and post-intervention scores of Berg Balance Scale (BBS) to evaluate the balance.
Data Collection Procedure The study was conducted by informed consent from participants. Assessment was performed before the intervention and after the intervention (after 6 weeks) from Trunk Impairment Scale (TIS) and Berg Balance Scale (BBS). Pre-interventional and post interventional scores were documented and analyzed the according to the statistical method.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Talha Mumtaz, Doctor of Physical Therapy
- Phone Number: 03351736446
- Email: drtalhamumtaz@gmail.com
Study Contact Backup
- Name: Nabeela Dawood, NMPT
- Phone Number: 03315337445
- Email: nabeelasafdar@gmail.com
Study Locations
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan
- Recruiting
- Ghurki Trust & Teaching Hospital
-
Contact:
- NABEELA, NMPT
- Phone Number: 03315337445
- Email: nabeelasafdar@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants between the ages of 45 and 60 years.
- Sub-acute phase of unilateral ischemic stroke.
- More than two weeks but no more than six months were included.
- Participants should be able to walk with or without support for 2-4 min.
- Participants with modified Ashworth scale grade 1 or grade 2.
- Participants should be able to understand and follow simple verbal instructions (Mini-Mental Status Examination [MMSE]≥24).
Exclusion Criteria:
- Participants with recurrent stroke; brainstem or cerebellar stroke or hemorrhagic stroke.
- Participants with modified Ashworth scale grade ≥3 (severe spasticity).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Participants who were included in this group got Pelvic Proprioceptive neuromuscular facilitation techniques + core strengthening group + Trunk control exercises (Conventional treatment).
|
Core activated by Bio Feedback apparatus and participants were given instructions to do trunk curls in crook lying position.
Asked to lift their upper trunk slightly (15 degree) from the plinth.
3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
Proprioceptive neuromuscular facilitation techniques The sequence was rhythmic initiation, slow reversal then agonistic reversals.
each technique was applied for 3 sets of 2 min duration each with 30 sec between each set and 2 min rest after each technique.
A stopwatch was used to measure the time.
Trunk control exercises Different trunk exercises were performed by the participants to develop trunk control and balance.
Rhythmic stabilization, Side-Lying Trunk Lifts, Bridging, Quadruped, Kneeling and modified plantigrade positioning, are the trunk exercises which were used conventionally to develop trunk control.
3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
|
|
Other: Control Group
Participants in group 2 received Core stabilization exercises + Conventional trunk control exercises (Rhythmic stabilization, Bridging, Side-Lying Trunk Lifts, Quadruped, Kneeling and modified plantigrade positioning) exercises.
3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
|
Core activated by Bio Feedback apparatus and participants were given instructions to do trunk curls in crook lying position.
Asked to lift their upper trunk slightly (15 degree) from the plinth.
3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
Trunk control exercises Different trunk exercises were performed by the participants to develop trunk control and balance.
Rhythmic stabilization, Side-Lying Trunk Lifts, Bridging, Quadruped, Kneeling and modified plantigrade positioning, are the trunk exercises which were used conventionally to develop trunk control.
3 sets with 10 repetitions each, 3 sec rest between each repetition, 1 min rest after each set and 3 min rest between each exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk Impairment Scale
Time Frame: • Baseline • After 6 weeks
|
The Trunk Impairment Scale (TIS) is a 17-item clinical tool assessing stroke patients across three subscales-static sitting balance (0-7 points), dynamic sitting balance (0--10points), and trunk coordination (0-6 points)-totaling a maximum score of 23.
Higher scores indicate better, more controlled, and coordinated trunk function, with evaluations performed in a seated position.
|
• Baseline • After 6 weeks
|
|
Berg Balance Scale
Time Frame: • Baseline • After 6 weeks
|
Berg Balance Scale (BBS) is identified as the most commonly used as an evaluation tool in the stroke rehabilitation.
We used the pre- and post-intervention scores of Berg Balance Scale (BBS) to evaluate the balance.
Total score of berg balance scale is 56.Highest score shows the low fall risk and the lowest score shows the high fall risk.
|
• Baseline • After 6 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Nabeela Dawood, Lahore University of Biological and Applied Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/FoRS/25/21686
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany
Clinical Trials on Core stabilization exercises
-
Fenerbahce UniversityCompletedExercise | ElderlyTurkey
-
Riphah International UniversityNot yet recruitingSacroiliac Joint DysfunctionPakistan
-
Dow University of Health SciencesRecruiting
-
Lahore University of Biological and Applied SciencesNot yet recruitingNon Specific Low Back PainPakistan
-
Medipol UniversityActive, not recruitingSedentary Behavior | Core StabilizationTurkey
-
Bezmialem Vakif UniversityCompletedAdolescent Idiopathic ScoliosisTurkey (Türkiye)
-
Hacettepe UniversityCompleted
-
Running Injury ClinicAlberta Health services; WCB AlbertaUnknownLow Back Pain, MechanicalCanada
-
Gazi UniversityAtaturk University; Erzurum Technical UniversityCompletedLow Back Pain | Lumbar Disc HerniationTurkey
-
Yeditepe UniversityIstanbul UniversityCompleted