Cerebral PalsyNCT05799703
Reciprocal Electrical Stimulation Versus Kinesio Taping
A study testing electrical stimulation device and kinesio taping in people with Cerebral Palsy, run by Basma Elsaid Mahmoud Bakr at 1 site in Egypt.
Trial summary
This study will be conducted to: 1. evaluate the effect of kinesio taping on hand functions in hemiplegic cerebral palsy children 2. compare between the effects of reciprocal electrical stimulation and kinesio taping on hand functions in hemiplegic cerebral palsy children. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- electrical stimulation device and kinesio taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2023to 30 Oct 2023
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A medical diagnosis of spastic hemiplegic CP made by paediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 1+ according to MAS.
- Their age range from 4 to 6 years.
- Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques
Who cannot join
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- Children with intelligence quotient less than 70.
- Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand.
- A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
- Children who are absent in two taping change sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Reciprocal Electrical Stimulation Versus Kinesio Taping On Hand Functions In Hemiparetic Cerebral Palsy Children
This study will be conducted to:
- evaluate the effect of kinesio taping on hand functions in hemiplegic cerebral palsy children
- compare between the effects of reciprocal electrical stimulation and kinesio taping on hand functions in hemiplegic cerebral palsy children.
Read the detailed description
- Patients preparation All the children demographic and outcome measures data will be collected in specially well-designed sheets1. Evaluation of fine motor skills using PDMS-2 Evaluation of hand function using Besta scale
. The traditional exercise program (given to both groups):
- Treatment protocol in Group A, Reciprocal electrical stimulation protocol
- The device has two channels that can stimulate two opposing groups of muscles alternatively (reciprocate).
- During ES, the child sits in a chair with his treated forearm resting on a pillow placed on the bed in front of him.
- The electrodes will be placed as follows:
- Channel 1 (stimulates wrist and hand extensors) electrodes placed over the dorsum of the forearm as follows: the active electrode is placed over the common extensor origin, while in different over the motor point of extensor pollicis longus, abductor pollicis longus, and extensor indices.
- Channel 2 (stimulates wrist and hand flexors) electrodes placed on the palmar side of the forearm are as follows: the negative electrode is placed between the finger flexors and wrist flexors. The positive electrode is placed over the tendonportion of the forearm,
- The treatment duration will be 20 minutes.
- The treatment protocol will be repeated 3 times per week for 12 weeks.
- Treatment protocol in Group B, Kinesio taping protocol:
- Kinesio taping will be applied on both sides of the upper limb.
- The applied area will be from the proximal one-third of the forearm to the wrist and then will be split into 5 straps into the distal interphalangeal joint of fingers.
- On the dorsal side, KT will be applied on the forearm, wrist, and fingers extensors for improvement of wrist and fingers extension.
- On the plantar side, KT will be applied on the forearm, wrist, and fingers flexors for inhibition of wrist and fingers flexion.
- Taping will be applied for 6 days, 24 h a day, on the affected upper limb, and it will be removed for only one day per week.
- Conditions
- Cerebral Palsy
- Being tested
- electrical stimulation device, kinesio taping
- Keywords
- kinesio taping, reciprocal electrical stimulation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulation deviceDevice
the device has 2 channels ,4 electrodes with multiple ems programs
kinesio tapingOther
kinesio tape a therapeutic tape that's applied strategically to the body to provide support, lessen pain, reduce swelling, and improve performance
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | will receive RES in addition to the traditional exercise program. Receives: Device: electrical stimulation device |
| Group (B) | Active comparator | will receive KT in addition to the traditional exercise program. Receives: Other: kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fine motor skills
we will use Peabody developmental motor scale-2 to assess fine motor skills
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start15 Feb 2023
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basma Elsaid Mahmoud Bakr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basma Elsaid Mahmoud Bakr, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799703
- Sponsor's protocol ID
- EG, KFS lab Research 6
- Status last verified
- Mar 2024
- First submitted
- 3 Mar 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Reciprocal Electrical Stimulation Versus Kinesio Taping On Hand Functions In Hemiparetic Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT05799703
- Acronym / sponsor ID
- EG, KFS lab Research 6
- Conditions
- Cerebral Palsy
- Keywords
- kinesio taping, reciprocal electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Basma Elsaid Mahmoud BakrUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 5 Apr 2023 (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.
This study will be conducted to:
- evaluate the effect of kinesio taping on hand functions in hemiplegic cerebral palsy children
- compare between the effects of reciprocal electrical stimulation and kinesio taping on hand functions in hemiplegic cerebral palsy children.
Detailed description
- Patients preparation All the children demographic and outcome measures data will be collected in specially well-designed sheets1. Evaluation of fine motor skills using PDMS-2 Evaluation of hand function using Besta scale
. The traditional exercise program (given to both groups):
- Treatment protocol in Group A, Reciprocal electrical stimulation protocol
- The device has two channels that can stimulate two opposing groups of muscles alternatively (reciprocate).
- During ES, the child sits in a chair with his treated forearm resting on a pillow placed on the bed in front of him.
- The electrodes will be placed as follows:
- Channel 1 (stimulates wrist and hand extensors) electrodes placed over the dorsum of the forearm as follows: the active electrode is placed over the common extensor origin, while in different over the motor point of extensor pollicis longus, abductor pollicis longus, and extensor indices.
- Channel 2 (stimulates wrist and hand flexors) electrodes placed on the palmar side of the forearm are as follows: the negative electrode is placed between the finger flexors and wrist flexors. The positive electrode is placed over the tendonportion of the forearm,
- The treatment duration will be 20 minutes.
- The treatment protocol will be repeated 3 times per week for 12 weeks.
- Treatment protocol in Group B, Kinesio taping protocol:
- Kinesio taping will be applied on both sides of the upper limb.
- The applied area will be from the proximal one-third of the forearm to the wrist and then will be split into 5 straps into the distal interphalangeal joint of fingers.
- On the dorsal side, KT will be applied on the forearm, wrist, and fingers extensors for improvement of wrist and fingers extension.
- On the plantar side, KT will be applied on the forearm, wrist, and fingers flexors for inhibition of wrist and fingers flexion.
- Taping will be applied for 6 days, 24 h a day, on the affected upper limb, and it will be removed for only one day per week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Device: electrical stimulation devicewill receive RES in addition to the traditional exercise program. |
| Group (B) | Active comparator | Other: kinesio tapingwill receive KT in addition to the traditional exercise program. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A medical diagnosis of spastic hemiplegic CP made by paediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 1+ according to MAS.
- Their age range from 4 to 6 years.
- Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques
Key exclusion criteria (6 listed)
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- Children with intelligence quotient less than 70.
- Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand.
- A history of epileptic seizure and any diagnosed cardiac or orthopaedic disability that may prevent the use of assessment methods.
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 |
|---|---|---|
| electrical stimulation devicethe device has 2 channels ,4 electrodes with multiple ems programs | Device | Group (A) |
| kinesio tapingkinesio tape a therapeutic tape that's applied strategically to the body to provide support, lessen pain, reduce swelling, and improve performance | Other | Group (B) |
Primary outcome
Fine motor skills
Time frame: 3 months
we will use Peabody developmental motor scale-2 to assess fine motor skills
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 12 Mar 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 electrical stimulation device and kinesio taping in people with Cerebral Palsy, run by Basma Elsaid Mahmoud Bakr 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 4 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 12 Mar 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. 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?
Fine motor skills (time frame: 3 months). 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 12 Mar 2024.