Balance Training With TENS for Spastic Diplegic Cerebral Palsy

NCT ID: NCT06424990

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-20
• Study Completion Date: 2024-07-30

Brief Summary

Children with spastic diplegic Cerebral Palsy (CP) often show motor impairment due to a number of deficits; including poor muscle control, weakness, spasticity and reduced range of motion in the extremities. All these factors affect the ability of children with CP to maintain balance and walk which are the primary rehabilitation concerns of parents and clinicians. The Balance Trainer provides a safe balance environment and assists with muscle activation of ankle and hip joints, and it is hypothesized that to promote spasticity inhibition, the use of TENS may decrease hyper-excitability, modulate reciprocal inhibition, and increase presynaptic inhibition. To the best of the authors' knowledge, the current study is the first research to investigate the effect of using Biodex balance training with TENS in improving children with spastic diplegia.

Conditions

Diplegic Cerebral Palsy

Study Design

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

Study Groups

study group

Group Type: EXPERIMENTAL

balance training with TENS

Intervention Type: OTHER

children will receive Biodex balance training with TENS for 30 minutes a day, 5 days per week for 4 weeks

control group

Group Type: PLACEBO_COMPARATOR

Balance training with placebo TENS

Intervention Type: OTHER

children will receive Biodex balance training with placebo TENS for the same period.

Interventions

balance training with TENS

children will receive Biodex balance training with TENS for 30 minutes a day, 5 days per week for 4 weeks

Intervention Type: OTHER

Balance training with placebo TENS

children will receive Biodex balance training with placebo TENS for the same period.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A diagnosis of spastic diplegia cerebral palsy.
• Age from 10 to 12 years.
• Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
• Level II motor function according to the Growth Motor Function Classification System.
• Able to understand and follow instructions.
• Their heights are more than 100 cm and weights are more than 20 Kg which are the lower limits of height and weight needed by the Biodex stability system.

Exclusion Criteria

• Epilepsy.
• Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
• Structural or fixed soft tissue deformities of the lower extremities.
• Neurological or orthopedic surgery in the past 12 months.
• Botox injection in the lower extremities in the past 6 months.
• Fracture, sprain, or strain injury of the lower extremities in the past 6 months.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Marwa Shafiek Mustafa Saleh

assistance professor doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

Other Identifiers

balancing with TENS for CP

Identifier Type: -

Identifier Source: org_study_id