NCT07808580

Brief Summary

Stroke is a leading cause of long-term disability and commonly results in impaired trunk control, postural instability, balance deficits, and reduced functional mobility due to disrupted sensorimotor integration, impaired proprioceptive processing, and decreased cortical excitability. Trunk control is a key determinant of balance, gait performance, and functional independence, making it a critical target in stroke rehabilitation. Transcranial Direct Current Stimulation (tDCS) enhances cortical excitability and promotes neuroplasticity through a top-down mechanism, while Pelvic Proprioceptive Neuromuscular Facilitation (PNF) improves trunk-pelvic control, weight shifting, and sensorimotor integration through a bottom-up proprioceptive facilitation mechanism. Emerging evidence suggests that combining tDCS with Pelvic PNF may improve trunk function and mobility in stroke survivors, supporting the concept of synergistic neuromodulation and motor facilitation. Despite the documented benefits of tDCS and Pelvic PNF individually, the combined application of these interventions remains insufficiently explored, particularly in subacute stroke patients. Most previous studies have focused on gait training, robotic rehabilitation, or other task-oriented interventions, with limited emphasis on trunk-focused pelvic PNF and postural control outcomes. Furthermore, few high-quality randomized controlled trials have evaluated whether simultaneous targeting of central neuroplasticity and peripheral proprioceptive facilitation provides superior improvements in trunk control, balance, and functional mobility. Therefore, this study aims to address this important clinical and methodological gap by investigate the combining effect of Pelvic PNF and tDCS, potentially establishing an evidence-based rehabilitation strategy that optimizes functional recovery after stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 2, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

transcranial direct current stimulationpelvic proprioceptive neuromuscular facilitationtrunk control, balance and functional mobility

Outcome Measures

Primary Outcomes (4)

  • Trunk impairement scale

    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.

    [Time Frame: baseline, week 6 and week 12]

  • Berg Balance Scale

    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.

    baseline, week 6 and week 12

  • Time up and go test

    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

    baseline, week 6 and week 12

  • Fugl-Meyer Assessment (FMA) for the lower extremity

    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.

    baseline, week 6 and week12

Study Arms (3)

Experimental: Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical therapy

EXPERIMENTAL

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.

Other: Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical Therapy

Experimental: Pelvic Proprioceptive Neuromuscular Facilitation and Routine Physical Therapy

EXPERIMENTAL

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.

Other: Pelvic Proprioceptive Neuromuscular Facilitation and Routine Physical Therapy

Experimental: Transcranial Direct Current Stimulation and Routine Physical Therapy

EXPERIMENTAL

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.

Other: Transcranial Direct Current Stimulation and Routine Physical Therapy

Interventions

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.

Experimental: Pelvic Proprioceptive Neuromuscular Facilitation and Routine Physical Therapy

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

Experimental: Transcranial Direct Current Stimulation and Routine Physical Therapy

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.

Experimental: Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical therapy

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Salma Physiotherapy Department Psrd Hospital 042-37423455

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 41964055BACKGROUND
  • 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.

    PMID: 36426303BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • psrd hospital

    Pakistan Society for Rehabilitation of Disabled Hospital Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study will use assessor blinding design in which outcome assessor will be unaware to group allocation throughout all assessment and will not involve in performing intervention. Blinding of participants and treating therapist is not possible due to nature of the intervention. To minimize potential bias, outcome assessment will be conduct by a blinded assessor using standardized assessment procedures and protocols.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will use a parallel-group design, with participants randomly allocated into three intervention groups. Group A receive Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical Therapy for 20 minutes. Group B receive Pelvic PNF and Routine Physical Therapy for 20 minute. Group C receive Transcranial Direct Current Stimulation and Routine Physical Therapy for 20 minute. 3 sessions per week for 12 weeks. .Participants will be randomly allocated into three parallel groups to ensure an unbiased comparison, with each group receiving its specific intervention protocol throughout the study period without crossover to the other groups intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

July 23, 2026

Primary Completion

September 1, 2026

Study Completion

September 1, 2026

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations