Balance Training With TENS for Spastic Diplegic Cerebral Palsy

NCT06424990 | Completed

• 1 other identifier: balancing with TENS for CP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

study group

EXPERIMENTAL

Other: balance training with TENS

control group

PLACEBO COMPARATOR

Other: Balance training with placebo TENS

Interventions

balance training with TENS OTHER

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

study group

Balance training with placebo TENS OTHER

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

control group

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistance professor doctor

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: May 22, 2024
• Study Start: May 20, 2024
• Primary Completion: July 20, 2024
• Study Completion: July 30, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

EG (1)