Balance Training With TENS for Spastic Diplegic Cerebral Palsy

Biodex Balance Training With Transcutaneous Electrical Nerve Stimulation for Children With Spastic Diplegia: A Double-blinded, Randomized, Placebo-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Diplegic Cerebral Palsy
• Intervention / Treatment: Other: balance training with TENS; Other: Balance training with placebo TENS

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group	Other: Balance training with placebo TENS; children will receive Biodex balance training with placebo TENS for the same period.
Experimental: study group	Other: balance training with TENS; children will receive Biodex balance training with TENS for 30 minutes a day, 5 days per week for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hip adductor spasticity	spasticity of hip adductors will be measured by the Modified Ashworth Scale. Modified ashworth scale grades of spasticity are as follows: 0 = normal muscle tone; 1= slight increase in muscle tone, manifested by catch and release or by minimal resistance at the end; 1+ = slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout; 2= more marked increase in muscle tone, but limb easily flexed; 3= considerable increase in muscle tone, passive movement difficult; and 4 = limb rigid in flexion or extension.	change from base line at 4 weeks.
spatio-temporal gait parameters	Spatiotemporal gait parameters (Walking Speed (WS) (m/s), Step Length (SL) (cm) and the Stance Time (ST) (%) on each limb) using GAITRite system which has excellent reliability for measuring most spatio-temporal gait parameters. The GAITRite is a 700 cm × 90 cm electronic walkway with an active sensor area of 610 cm long and 60 cm wide. The active area contains 23,040 embedded pressure-activated sensors with a spatial resolution of 1.27 cm and a sampling rate of 120 Hz. All data was processed and stored by an IBM compatible computer using GAITRite® gold, Version 3.2b software.	change from base line at 4 weeks.
balance assessment	anteroposterior stability index, mediolateral stability index, and overall stability index will be measured using Biodex balance system. Biodex Stability System has an intertester intraclass correlation coefficients (ICCs) equals 0.70 and an intratester ICCs equals 0.82. Biodex Stability System formed of a dynamic platform that allows movements to occur around the anterior-posterior (AP) and mediallateral (ML) axes simultaneously. Biodex Stability System has a screen displaying the child's position on it and a support handle that can be adjusted according to each child's height. The screen gives visual feedback about the degree of tilting that helps the child to maintain the cursor in the center of the screen to obtain a good score of balance. The higher the scores, the poorer the balance of the child	change from base line at 4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): July 20, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: May 11, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: balancing with TENS for CP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No