Stroke, Subacute Stroke
Conditions
Keywords
transcranial direct current stimulation, pelvic proprioceptive neuromuscular facilitation, trunk control, balance and functional mobility
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.
Detailed description
Stroke is a neurological disorder caused by a disruption of blood supply because of cerebral infarction or hemorrhage. Stroke is a leading cause of long-term disability worldwide, with balance impairment recognized as one of the most disabling sequel affecting functional independence and quality of life. In Pakistan, the annual incidence of stroke is estimated at 250 per 100,000 people, and stroke is the second leading cause of death with a mortality rate of about 9.3%. Postural control and balance impairment are common issues among patients with stroke. It has been estimated that approximately 83% of patients with stroke experience difficulties in maintaining balance. Effective trunk control, often referred to as core stability, is therefore a fundamental component of motor performance and postural control. Selective trunk exercises designed to improve trunk coordination and control can boost balance and gait parameters among stroke subjects. Transcranial direct current stimulation (tDCS) is one of the most used noninvasive brain stimulation techniques. Transcranial direct current stimulation (tDCS) is a means of increasing cortical excitability by promoting synaptic plasticity in the cerebral cortex. A new "top-down" approach to enhance stroke rehabilitation outcomes. The Pelvic Proprioceptive Neuromuscular Facilitation facilitates the control of trunk and lower extremity motion and provide mobility and stability to trunk. The use of Pelvic PNF facilitates neuromuscular coordination through specific movement patterns, which enhance trunk stability and postural control. The Pelvic PNF facilitates the trunk and lower extremity motion and also provides the stability to trunk. It also promotes the exploration of postural reflexes and prioritizes eccentric muscle contraction, stimulating agonist activity. Pelvic Proprioceptive Neuromuscular Facilitation (PNF) improves trunk-pelvic control, weight shifting, and sensorimotor integration through a bottom-up proprioceptive facilitation mechanism. This study will contribute to knowledge by providing evidence regarding the combined effects of Pelvic PNF and tDCS on trunk control, balance, and functional mobility in subacute stroke patients. The findings will contribute to the existing body of knowledge by providing evidence regarding synergistic effect of these interventions. Clinically the results may help physiotherapist develop more effective, evidence-based treatment protocols for improving trunk control and functional independence. By comparing these groups, the study will determine whether adding tDCS to Pelvic PNF provides better functional recovery by enhancing both cortical excitability and peripheral proprioceptive input. This is important because stroke rehabilitation currently lacks clear evidence on the most effective combination of top-down (neuromodulation) and bottom-up (sensorimotor facilitation) approaches. The findings may help establish a more effective, evidence-based intervention strategy for trunk control and mobility impairments, which are key determinants of independence after stroke. At the community level, improved balance and mobility can reduce fall risk, decrease dependency on caregivers, enhance participation in daily and social activities, and better quality of life. Additionally, effective rehabilitation may reduce long-term disability and healthcare burden, making stroke management more cost-effective and accessible for the community. Experimental Group A will receive Pelvic PNF and Transcranial Direct Current Stimulation and Routine Physical Therapy while Experimental Group B will receive Pelvic PNF and Routine Physical Therapy and Experimental Group C Transcranial Direct Current Stimulation and Routine Physical Therapy. . 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.
Interventions
OTHERPelvic PNF and 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.
OTHERPelvic Proprioceptive Neuromuscular Facilitation and Routine Physical Therapy
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.
OTHERTranscranial 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. 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
Sponsors
Lahore University of Biological and Applied Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trunk impairement scale | [Time Frame: baseline, week 6 and week 12] | 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. |
| Berg Balance Scale | baseline, week 6 and week 12 | 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. |
| Time up and go test | baseline, week 6 and week 12 | 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 |
| Fugl-Meyer Assessment (FMA) for the lower extremity | baseline, week 6 and week12 | 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. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORpsrd hospital
Pakistan Society for Rehabilitation of Disabled Hospital Lahore
Outcome results
None listed