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

NCT07587476 | Recruiting DMC

• 1 other identifier: UOL/IREB/25/15/03/14
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy (CP)

Keywords

Constraint-Induced Movement Therapy; Functional Electrical Stimulation (FES); Upper Limb Rehabilitation; Spasticity

Outcome Measures

Primary Outcomes (1)

• Change in Upper Limb Function Using Melbourne Assessment of Unilateral Upper Limb Function (MUUL)

  Upper limb function will be assessed using the Melbourne Assessment of Unilateral Upper Limb Function (MUUL), which evaluates the quality of unilateral upper extremity movement including reach, grasp, release, and object manipulation in children with cerebral palsy. Higher scores indicate better upper limb motor performance and functional ability.

  3 weeks and after 6 weeks of intervention

Study Arms (2)

group A CIMT Combined with FES Group

EXPERIMENTAL

Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) combined with Functional Electrical Stimulation (FES) for the affected upper limb. Therapy will be conducted five sessions per week for six weeks, with each session lasting 60 minutes. CIMT will involve restraining the unaffected upper limb using a mitt or sling to encourage use of the affected limb during task-oriented activities such as reaching, grasping, releasing, drawing, stacking, and object manipulation. Functional Electrical Stimulation will be applied to targeted upper limb muscles including wrist extensors and finger muscles using therapeutic stimulation parameters to facilitate voluntary motor control and neuromuscular re-education.

Procedure: Constraint-Induced Movement Therapy Combined with Functional Electrical Stimulation

group B CIMT Alone Group

ACTIVE COMPARATOR

Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) alone for six weeks, five sessions per week, with each session lasting 60 minutes. The unaffected upper limb will be restrained using a mitt or sling to encourage repetitive use of the affected upper limb during functional and task-specific activities. Activities will include self-care tasks, play-based exercises, grasp and release training, drawing, stacking blocks, and object handling exercises tailored to the child's functional level. No electrical stimulation will be administered in this group.

Procedure: Constraint-Induced Movement Therapy

Interventions

Constraint-Induced Movement Therapy Combined with Functional Electrical Stimulation PROCEDURE

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.

group A CIMT Combined with FES Group

Constraint-Induced Movement Therapy PROCEDURE

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.

group B CIMT Alone Group

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Montiha Azeem: lead

Study Sites (1)

Hira medical center Sukkur

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Muhammad Hafeezullah Tariq, MSPPT

  The University of Lahore, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Hafeezullah Tariq, MSPPT

CONTACT

03140029255; mangihafeezullah7@gmail.com

Montiha Azeem, MSPTN

CONTACT

03479717317; muntahaazeem9@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): June 29, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

PA (1)