Effects of Functional Electrical Stimulation Combined With Task-Oriented Training on Lower Limb Function, Balance, and Quality of Life in Children With Spastic Diplegic Cerebral Palsy.

Spastic diplegic cerebral palsy is a subtype of cerebral palsy characterized by predominantly lower-limb involvement, often resulting in increased muscle tone, muscle weakness, impaired selective motor control, and difficulties with standing, walking, balance, and functional mobility. These impairments can restrict children's participation in daily activities and negatively affect their functional independence and quality of life. Routine physiotherapy is commonly used to address these limitations; however, improvements in basic motor performance may not always translate into better performance of functional activities requiring coordinated movement, postural stability, and dynamic balance. Therefore, rehabilitation approaches that combine targeted muscle activation with repetitive, goal-directed functional practice may offer additional benefits for children with spastic diplegic cerebral palsy.

Functional Electrical Stimulation (FES) uses controlled electrical impulses to stimulate peripheral motor nerves and produce muscle contraction. When appropriately applied during functional activities, FES may facilitate muscle activation and support movement performance. Task-Oriented Training (TOT) is a rehabilitation approach based on repetitive practice of meaningful, goal-directed activities designed to improve motor learning, functional performance, and the transfer of acquired skills into everyday activities. Combining FES with TOT may provide additional benefits by facilitating targeted muscle activation while children practice functional movements. However, evidence regarding the combined effects of FES and task-oriented training on lower-limb function, balance, and quality of life in young children with spastic diplegic cerebral palsy remains limited. This study is designed to address this gap by comparing the effects of FES combined with TOT and TOT alone.

This study will be conducted as a two-arm, parallel-group randomized clinical trial involving 44 children aged 3-7 years with spastic cerebral palsy who meet the predefined eligibility criteria. Participants will be randomly allocated to either the experimental group or the control group in a 1:1 ratio. A computer-generated randomization sequence will be prepared by an independent researcher who will not be involved in participant recruitment, treatment, or outcome assessment. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Participants will undergo a six-week intervention program consisting of three supervised sessions per week, with each session lasting 60 minutes. The experimental group will receive Functional Electrical Stimulation combined with Task-Oriented Training, while the control group will receive Task-Oriented Training alone. The FES intervention will target the gluteus medius muscle to facilitate muscle activation during standing and functional movement activities. Electrical stimulation will be delivered using a frequency of 35 Hz, a pulse width of 250 microseconds, a ramp time of 1-2 seconds, and an on-to-off ratio of 1:3. Stimulation intensity will be adjusted according to the child's tolerance to achieve visible and comfortable muscle contractions.

Task-Oriented Training will involve progressive, structured practice of functional activities selected to address standing control, weight shifting, stepping, walking, dynamic balance, and functional mobility. During the first week, training will focus on sit-to-stand transitions, standing weight shifts in side-to-side and forward-backward directions, and level-surface walking. During the second week, activities will progress to overground walking, step initiation, and forward and lateral stepping. The third week will include obstacle crossing, stepping over floor markers, and multidirectional stepping to challenge dynamic balance and movement coordination. During the fourth week, participants will practice step-ups, stair negotiation, and tandem walking. The fifth week will incorporate changes in walking direction, variations in walking speed, and dual-task walking activities. During the sixth week, training will progress to advanced gait activities, obstacle negotiation, and simulated community mobility tasks according to each child's functional ability and tolerance.

The primary outcome will be gross motor function, assessed using the Gross Motor Function Measure (GMFM-88), with particular consideration of standing and walking-related abilities. Secondary outcomes will include balance, functional independence, and health-related quality of life. Balance will be evaluated using the Pediatric Balance Scale (PBS), functional independence using the Pediatric Functional Independence Measure (WeeFIM), and health-related quality of life using the Pediatric Quality of Life Inventory (PedsQL). These outcome measures will be used to determine whether combining FES with task-oriented training produces greater improvements than task-oriented training alone.

Outcome assessments will be conducted at baseline (Week 0) before the intervention begins and immediately after completion of the six-week intervention program (Week 6). Changes in gross motor function, balance, functional independence, and quality of life will be evaluated within and between the two groups to determine the effectiveness of the interventions.

The findings of this study may provide evidence regarding the effectiveness of combining Functional Electrical Stimulation with Task-Oriented Training in improving lower-limb function, balance, functional independence, and quality of life in children with spastic diplegic cerebral palsy.