Diplegic Cerebral PalsyNCT06424990
Balance Training With TENS for Spastic Diplegic Cerebral Palsy
A study testing balance training with TENS in people with Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- balance training with TENS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- balance training with TENS, Balance training with placebo TENS
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance training with TENSOther
children will receive Biodex balance training with TENS for 30 minutes a day, 5 days per week for 4 weeks
Balance training with placebo TENSOther
children will receive Biodex balance training with placebo TENS for the same period.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Not described Receives: Other: balance training with TENS |
| control group | Placebo comparator | Not described Receives: Other: Balance training with placebo TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: change from base line at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start20 May 2024
- Primary completion20 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Shafiek Mustafa Saleh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424990
- Sponsor's protocol ID
- balancing with TENS for CP
- Status last verified
- Sep 2024
- First submitted
- 11 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodex Balance Training With Transcutaneous Electrical Nerve Stimulation for Children With Spastic Diplegia: A Double-blinded, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06424990
- Acronym / sponsor ID
- balancing with TENS for CP
- Conditions
- Diplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: balance training with TENS |
| control group | Placebo comparator | Other: Balance training with placebo TENS |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balance training with TENSchildren will receive Biodex balance training with TENS for 30 minutes a day, 5 days per week for 4 weeks | Other | study group |
| Balance training with placebo TENSchildren will receive Biodex balance training with placebo TENS for the same period. | Other | control group |
Primary outcome
hip adductor spasticity
Time frame: change from base line at 4 weeks.
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.
spatio-temporal gait parameters
Time frame: change from base line at 4 weeks.
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.
balance assessment
Time frame: change from base line at 4 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance training with TENS in people with Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hip adductor spasticity (time frame: change from base line at 4 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.