Weight Bearing Exercises With NMES on Balance and Functional Abilities In Children With Hemiplegia

NCT ID: NCT07069946

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-12-15

Brief Summary

This study will be conducted to investigate the combining effect of weight-bearing exercises program with neuromuscular electrical stimulation on balance and functional abilities in children with hemiplegic cerebral palsy.

Detailed Description

Hemiplegic cerebral palsy (HCP) is characterized by unilateral motor impairment, with the upper extremities typically exhibiting greater functional limitations compared to the lower limbs. This subtype constitutes approximately 20-30% of cerebral palsy cases and arises from unilateral injury to the developing brain, resulting in asymmetrical muscle tone abnormalities, joint deformities, and restricted range of motion. Individuals with HCP often display irregular, uncoordinated movements on the affected side, significantly impacting motor performance. Children with spastic hemiplegia experience decreased balance ability and abnormal gait because of decreased weight-bearing in the paretic leg. Diminished motor ability in the paretic leg causes weakening of the quadriceps, ankle plantar flexors, and ankle dorsiflexors.

The rehabilitation of balance and walking ability is crucial for children diagnosed with cerebral palsy. Weight-bearing exercises are defined as physical activities in which the feet and legs support the body's weight while moving against gravity. These exercises are essential for stimulating bone growth, improving bone density, and enhancing musculoskeletal health. Examples of weight-bearing exercises include walking, running, jumping, dancing, climbing stairs, playing sports such as soccer or basketball, and engaging in recreational activities like hiking or skating. Regular participation in weight-bearing exercises is particularly important for children and adolescents, as it helps maximize peak bone mass during growth and reduces the risk of osteoporosis later in life.

Exercise programs for cerebral palsy exhibit significant variation in terms of their types, such as gait training, body-weight-supported treadmill training, balance training, or multi-component approaches, and the efficacy of different exercises has not been established in improving the functional abilities of children with cerebral palsy. Studies suggest that integrating neuromuscular electrical stimulation (NMES) with conventional rehabilitation approaches enhances therapeutic outcomes compared to using NMES in isolation .

Conditions

Hemiplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

This group will include 15 children with hemiplegic cerebral palsy and will receive a split 60 minutes, 30 minutes of traditional physical therapy and 30 minutes of weight-bearing exercise , 3 sessions/ week for 8 weeks.

Group Type: ACTIVE_COMPARATOR

traditional physical therapy and weight-bearing exercise

Intervention Type: OTHER

They will receive 60 minute session, 3 times/ week for 8 weeks as following:

• 30 minutes of traditional physical therapy program : Includes: Strengthening, Stretching, Balance, Postural Control, Functional Mobility and Gait Training.
• 30 minutes of seven different weight-bearing exercises program of exercises with three of those being repeated on the left and right sides to make a total of ten exercises, each held for 3 minutes, the exercises include: hamstring stretch, calf stretch, half kneeling balance, static squat, bridge, four point kneeling and four point kneeling with leg extension the exercises include: : Hamstring stretch,Calf stretch , Half kneeling balance , Static Squat, Bridge, Four point kneeling with leg extension, and Four point kneeling.

Study group

This group will include 15 children with hemiplegic cerebral palsy and will receive the same 60 minutes session of the control group in addition to neuromuscular electrical stimulation during the 30 minutes weight-bearing program , 3 sessions/ week for 8 weeks.

Group Type: EXPERIMENTAL

neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise

Intervention Type: OTHER

They will receive 60 minute session, 3 times/ week for 8 weeks as following:

• 30 minutes of the same traditional physical therapy as the control group.
• 30 minutes of the same weight-bearing exercises program as the control group adding to it the neuromuscular electrical stimulation on: Tibialis anterior, Quadriceps, Paraspinal muscles.
• NMES Parameters :

• Device: Everyway-EV-906.
• Frequency: 30-35 Hz (to optimize muscle endurance and motor unit recruitment).
• Pulse Width: 250-300 µs.
• Intensity: Adjusted to elicit visible muscle contraction without discomfort (submaximal, (25-30 mA).
• Electrode Placement:

• Lower Limb: Tibialis anterior (for dorsiflexion) and quadriceps (for knee stability) during weight-bearing (El-Shamy and El Kafy, 2021).
• Trunk: Paraspinal muscles (for postural control) during static squats and bridging

Interventions

traditional physical therapy and weight-bearing exercise

They will receive 60 minute session, 3 times/ week for 8 weeks as following:

• 30 minutes of traditional physical therapy program : Includes: Strengthening, Stretching, Balance, Postural Control, Functional Mobility and Gait Training.
• 30 minutes of seven different weight-bearing exercises program of exercises with three of those being repeated on the left and right sides to make a total of ten exercises, each held for 3 minutes, the exercises include: hamstring stretch, calf stretch, half kneeling balance, static squat, bridge, four point kneeling and four point kneeling with leg extension the exercises include: : Hamstring stretch,Calf stretch , Half kneeling balance , Static Squat, Bridge, Four point kneeling with leg extension, and Four point kneeling.

Intervention Type: OTHER

neuromuscular electrical stimulation , traditional physical therapy and weight-bearing exercise

They will receive 60 minute session, 3 times/ week for 8 weeks as following:

• 30 minutes of the same traditional physical therapy as the control group.
• 30 minutes of the same weight-bearing exercises program as the control group adding to it the neuromuscular electrical stimulation on: Tibialis anterior, Quadriceps, Paraspinal muscles.
• NMES Parameters :

• Device: Everyway-EV-906.
• Frequency: 30-35 Hz (to optimize muscle endurance and motor unit recruitment).
• Pulse Width: 250-300 µs.
• Intensity: Adjusted to elicit visible muscle contraction without discomfort (submaximal, (25-30 mA).
• Electrode Placement:

• Lower Limb: Tibialis anterior (for dorsiflexion) and quadriceps (for knee stability) during weight-bearing (El-Shamy and El Kafy, 2021).
• Trunk: Paraspinal muscles (for postural control) during static squats and bridging

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children diagnosed with hemiplegic cerebral palsy.
• Their age will range from 6-10 years.
• Both sexes will be included.
• All participants will be able to follow simple commands.
• They will be graded as mild spasticity of the lower limbs according to MAS grade 1 to 1+ .
• They will be at levels I and II based on the GMFCS

Exclusion Criteria

• Children with any neurological conditions other than hemiplegic cerebral palsy will be excluded from the study.
• Musculoskeletal problems or congenital deformity.
• Children with fixed contracture.
• Lower limb surgery in the last one year.
• Rhizotomy, or injection of botulinum toxin into the lower limb muscles during the previous 6 months.
• Receive any medications that affect the arousal and alertness status.
• Children having epilepsy.
• Visual or auditory defects.
• Skin sensitivity.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Abdulrahman Ahmad Mohamad Mostafa

Abdulrahman Ahmad Mohamad Mostafa

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abdulrahman Mostafa, MSc.

Role: PRINCIPAL_INVESTIGATOR

Master degree

Central Contacts

Abdulrahman Mostafa, Master

Role: CONTACT

ar.ahmad93pt@gmail.com

0 11 01012521

Abdulrahman Mostafa

Role: CONTACT

Other Identifiers

No:P.T.REC/012/005783

Identifier Type: -

Identifier Source: org_study_id