Effect of Transcranial Direct Current Stimulation and Pelvic Proprioceptive Neuromuscular Facilitation in Stroke Patient
Effects of Transcranial Direct Current Stimulation and Pelvic Proprioceptive Neuromuscular Facilitation on Trunk Control, Balance and Functional Mobility in Stroke Patients
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Studietype
Inschrijving (Werkelijk)
Inschrijving
Fase
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Dr Salma Physiotherapy Department Psrd Hospital 042-37423455
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Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Both genders
- Middle Cerebral Artery Ischemic Stroke
- Subacute phase of stroke
- Patients experiencing their first ever stroke
- Brunnstrom stage 3
- Patients is capable to follow commands
Exclusion Criteria:
- Frequent seizures or epileptic disorder
- Contractures in the spine and lower limb
- Patients with uncontrolled medical conditions e.g. severe musculoskeletal pain, uncontrolled heart disease, uncontrolled hypertension
- Metallic implant
- History of brain tumor, orthopedic, neurosurgical surgery
- Concurrent participation in another clinical trial.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
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Experimenteel: Experimental: Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical therapy
group A will receive pelvic propriceptive neuromuscualar facilitation and transcranial direct current stimulation with routine physical therapy.
The participants will receive 20 min session of transcranial direct current stimulation with intensity of 2 mA in which anodal tDCS applied over ipsilateral side.
Then 20 min session of pelvic PNF will perform with 10 repitition per set for 3 set.
pelvic PNF pattern perform as anterior elevation and posterior elevation using rthymic initiation, slow reversal and stabilizing reversal will perform, Then perform routine therapy as ROM, Bridging, trunk flexion and swiss ball perform for 20 minutre.
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The patients will sit comfortably on a chair, with their hip and knee joints positioned at 90 degrees and their forearms resting on a table in front of the chair.
For the groups receiving tDCS, a wireless rechargeable tDCS device will use.
This device use two 5-7 cm-long sponge electrodes that will soak in 0.9% saline.
The electrodes will be carefully wrap around the patient's head.
The brain remains excited for up to 20 min following tDCS.
The tDCS will administered at a intensity of 2 mA, for 20 min, with a 30 sec ramp-up and ramp-down at the beginning and end of stimulation.
The PNF will be perform at 10 repetitions per set, with 3sets per session, conducted 3 sessions per week over a duration of 12 weeks.
Each session lasted 20 min.
Pelvic PNF pattern as anterior elevation and posterior elevation using rthymic initiation and slow reversal.
RPT include ROM, trunk flexion, bridging and swiss ball exercises.
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Experimenteel: Experimental: Pelvic Proprioceptive Neuromuscular Facilitation and Routine Physical Therapy
Group B will receive pelvic proprioceptive neuromuscular facilitation with routine physical therapy.
In this group patient receive 20 min session of pelvic PNF with 10 repititions per set for 3 set per session apply moderate manual resistance according to patient tolerance.
Patient should be in side lying position then apply PNF pattern as anterior and posterior elevation using rthymic initiation , slow reversal and stabilizing reversal.
the routine physical therapy involve 20 repetition with moderate intensity with 3 sessions per week it involve the ROM, bridging, trunk flexion and exercise on swiss ball.
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The PNF treatment will be perform at a dosage of 10 repetitions per set, with 3sets per session, conducted 3 sessions per week over a duration of 12 weeks.
Each session lasted 20 minutes, depending on the participant's endurance and response to therapy.
The treatment will performed on the affected side, with the hips flexed to 100° and the knees flexed to 45°.
For anterior elevation, the therapist's hands will placed just on the subject's anterior iliac spine, and for posterior depression, they will placed on the patient's ischial tuberosity.
"Pull up" for anterior elevation, and "push down" and "sit into my hands" for posterior depression.
Rhythmic initiation, Slow reversal and stabilizing reversal will used.
routine physical therapy involve Sitting posture exercises as controlled forward flexion, trunk rotation to right and left.
Supine position exercises as hip roll to both sides, bridging exercise Dynamic sitting exercise on swiss ball as controlled lateral weight shifting.
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Experimenteel: Experimental: Transcranial Direct Current Stimulation and Routine Physical Therapy
Group C will receive transcranial direct current stimulation and routine physical therapy.
The participants will receive 20 min session.
tDCS pads will soaked in saline and then apply to patients head.
Anodal tDCS apply over ipsilesional side with current of 2mA with 30 second ramp up and down in the begining and end of stimulation.
the routine physical therapy involve 20 repetition with moderate intensity with 3 sessions per week it involve the ROM, bridging, trunk flexion and exercise on swiss ball.
|
The patients will sit comfortably on a chair, with their hip and knee joints positioned at 90 degrees and their forearms resting on a table in front of the chair.
For the groups receiving tDCS, a wireless rechargeable tDCS device will use.
This device use two 5-7 cm-long sponge electrodes that will soak in 0.9% saline.
The electrodes will be carefully wrap around the patient's head.
The brain remains excited for up to 20 min following tDCS.
The tDCS will administered at a intensity of 2 mA, for 20 min, with a 30 sec ramp-up and ramp-down at the beginning and end of stimulation.
routine physical therapy involve Sitting posture exercises as controlled forward flexion, trunk rotation to right and left.
Supine position exercises as hip roll to both sides, bridging exercise Dynamic sitting exercise on swiss ball as controlled lateral weight shifting for 20 min duration
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Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Trunk impairement scale
Tijdsspanne: [Time Frame: baseline, week 6 and week 12]
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Trunk impairment scale evaluates static and dynamic trunk balance and trunk coordination.
These tasks are design to reflect the patient's ability to activate trunk musculature, which is often impaired after stroke.
It evaluates three components: static sitting balance (score range 0-7), dynamic sitting balance (0-10), and trunk coordination (0-6).
The total score ranges from 0 to 23, with higher scores indicating better trunk performance.
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[Time Frame: baseline, week 6 and week 12]
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Berg Balance Scale
Tijdsspanne: baseline, week 6 and week 12
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The BBS is a 14-item ordinal scale that measures balance performance during functional tasks such as sitting, standing, and weight shifting.
Each item is rate on a 5-point scale (0-4), with a maximum total score of 56.
Higher scores indicate better balance ability.
It has excellent inter-rater reliability, with ICC values of 0.989.
Concurrent validity (r = 0.970).
Interpretation of 0 to 20 (High Risk): Severe balance impairment; patients typically require a wheelchair for mobility and significant assistance.
21 to 40 (Moderate Risk): Increased fall risk; these individuals typically require walking aids and environmental modifications.
41 to 56 (Low Risk): Good balance function with minimal fall risk.
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baseline, week 6 and week 12
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Time up and go test
Tijdsspanne: baseline, week 6 and week 12
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This test measures functional mobility and fall risk by timing the patient as they rise from a chair, walk a short distance, turn around, return, and sit down.
The time taken is record in seconds and categorized into normal mobility, low, moderate, or high fall.
Reliability ICC for the TUG were 0.998 and 0.992
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baseline, week 6 and week 12
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Fugl-Meyer Assessment (FMA) for the lower extremity
Tijdsspanne: baseline, week 6 and week12
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This scale measure the motor control in stroke patients.
FMA consists of 17 items, with a maximum total score of 34 points.
Each task is rate on a 3-point ordinal scale.
0: Movement cannot be performed, 1: Movement can be performed partially, 2: Movement can be performed fully.
The higher the score, the better your motor recovery.
The scores indicate: 0-10: Severe motor impairment, 11-23: Moderate motor impairment, 24-33: Mild motor impairment, 34: Minimal to no impairment (full motor recovery).
Reliability, with Intra-class Correlation Coefficient (ICC) values 0.90 to 0.97 high inter-and intra-rater reliability (ICC > 0.90) for the total FMA-LL score.
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baseline, week 6 and week12
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Medewerkers en onderzoekers
Sponsor
Sponsor
Onderzoekers
Onderzoekers
- Hoofdonderzoeker: psrd hospital, Pakistan Society for Rehabilitation of Disabled Hospital Lahore
Publicaties en nuttige links
Algemene publicaties
- El-Sherbini AEIEM, Elgayar SL, Elhamrawy MY, Youssef TM. Unlocking trunk potential after stroke: a novel approach combining transcranial direct current stimulation and core stability exercise: a randomized controlled trial. J Neuroeng Rehabil. 2026 Apr 10;23(1):128. doi: 10.1186/s12984-026-01949-0.
- Boob MA, Kovela RK. Effectiveness of Pelvic Proprioceptive Neuromuscular Facilitation Techniques on Balance and Gait Parameters in Chronic Stroke Patients: A Randomized Clinical Trial. Cureus. 2022 Oct 24;14(10):e30630. doi: 10.7759/cureus.30630. eCollection 2022 Oct.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
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Primaire voltooiing (Werkelijk)
Primaire voltooiing
Studie voltooiing (Werkelijk)
Studie voltooiing
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Cerebrovasculaire aandoeningen
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Vaatziekten
- Hart-en vaatziekten
- Hartinfarct
- Therapeutica
- Gedragsdisciplines en activiteiten
- Elektrische stimulatietherapie
- Convulsieve therapie
- Psychiatrische somatische therapieën
- Electroshock
- Psychologische technieken
- Transcraniale directe stroomstimulatie
Andere studie-ID-nummers
Andere studie-ID-nummers
- UBAS/ERB/26/07/080
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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