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Balance Training With TENS for Spastic Diplegic Cerebral Palsy

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Diplegic Cerebral Palsy

Treatments

Other: balance training with TENS
Other: Balance training with placebo TENS

Study type

Interventional

Funder types

Other

Identifiers

NCT06424990
balancing with TENS for CP

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

10 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

study group
Experimental group
Treatment:
Other: balance training with TENS
control group
Placebo Comparator group
Treatment:
Other: Balance training with placebo TENS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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