RecruitingNot ApplicableNCT07587476

Constraint-induced Movement Therapy Combined With Functional Electrical Stimulation in Children With Cerebral Palsy


Sponsor

Montiha Azeem

Enrollment

46 participants

Start Date

May 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized controlled trial aims to compare the effectiveness of Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) versus CIMT alone in improving upper limb function, reducing spasticity, and enhancing functional independence in children with cerebral palsy (CP). A total of 46 children aged 3 to 15 years with spastic or dyskinetic cerebral palsy will be recruited from rehabilitation centers and hospitals in Sukkur, Pakistan. Participants will be randomly assigned into two groups: Group A will receive CIMT combined with FES, while Group B will receive CIMT alone. Both groups will undergo supervised therapy sessions five times per week for six weeks. Outcomes will be assessed before and after treatment using the Modified Ashworth Scale (MAS), Melbourne Assessment of Unilateral Upper Limb Function (MUUL), and Pediatric Evaluation of Disability Inventory (PEDI). The study aims to determine whether combining FES with CIMT provides greater improvements in motor recovery and daily functional performance in children with CP.


Eligibility

Min Age: 3 YearsMax Age: 15 Years

Inclusion Criteria4

  • Children aged 3 to 15 years, including both male and female population. Diagnosed with cerebral palsy (CP), confirmed by medical assessment and clinical evaluation.
  • Moderate to severe impairment in upper limb function (as determined by a relevant motor function assessment scale, e.g., the Modified Ashworth Scale.
  • Children with spastic and dyskinetic types of cerebral palsy. Children with cognitive ability that allows for participation in therapy, as determined by minimental status examination.
  • No history of recent interventions (e.g., surgery, Botox injections) that may interfere with study participation.

Exclusion Criteria2

  • Children with contraindications to functional electrical stimulation (e.g., pacemaker, skin conditions, or open wounds in the area of electrode placement).
  • Presence of other significant neurological or musculoskeletal disorders that could confound the results (e.g., traumatic brain injury, muscular dystrophy)

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Interventions

PROCEDUREConstraint-Induced Movement Therapy Combined with Functional Electrical Stimulation

This intervention combines Constraint-Induced Movement Therapy (CIMT) with Functional Electrical Stimulation (FES) for rehabilitation of the affected upper limb in children with cerebral palsy. The unaffected upper limb will be restrained using a mitt or sling to encourage active use of the affected limb during repetitive, task-oriented activities such as reaching, grasping, stacking, drawing, and object manipulation. Functional Electrical Stimulation will be applied to selected upper limb muscles including wrist extensors and finger muscles using therapeutic electrical stimulation parameters (pulse width 200-300 microseconds, frequency 35-50 Hz, and on-off cycle of 10 seconds on and 20 seconds off). The intervention will be delivered for 60 minutes per session, five sessions per week, for six weeks under physiotherapist supervision.

PROCEDUREConstraint-Induced Movement Therapy

Constraint-Induced Movement Therapy (CIMT) will be provided to improve upper limb function in children with cerebral palsy by encouraging repetitive use of the affected extremity. The unaffected upper limb will be restrained using a mitt or sling while children perform structured, task-specific activities including grasping, reaching, releasing, drawing, feeding-related activities, stacking blocks, and play-based functional tasks. Therapy sessions will last 60 minutes each, five times per week for six weeks, with progression in task difficulty according to the child's functional abilities. No electrical stimulation will be applied in this intervention.


Locations(1)

Hira medical center Sukkur

Lahore, Punjab Province, Pakistan

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NCT07587476


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