Erb's PalsyNCT05334511
Functional Electrical Stimulation On Functional Rehabilitation In Children With Erb's Palsy
A study testing Functional Electrical Stimulation in people with Erb's Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Erb's palsy is a type of brachial plexus injury occurs in infants due to injury of nerves during childbirth. Injury causes weakness or paralysis of different muscles. Different type of approaches are made for the treatment of erb;s palsy such passive range of motion, stretching ,splinting ,electrotherapy etc. Read more about this study
- Who is it for?
- Ages 15 months to 3 years
- Conditions the study is for
- Erb's Palsy
- What is being tested?
- Functional Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Nov 2021to 31 Jul 2022
- 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 15 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with Erb's Palsy
- Children of age 15 months to 3 years
Who cannot join
- hemiplegic cerebral palsy
- children with upper limb fractures
- obstetrical brachial plexus injury
- upper limb contracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Functional Electrical Stimulation On Functional Rehabilitation In Children With Erb's Palsy
Erb's palsy is a type of brachial plexus injury occurs in infants due to injury of nerves during childbirth. Injury causes weakness or paralysis of different muscles. Different type of approaches are made for the treatment of erb;s palsy such passive range of motion, stretching ,splinting ,electrotherapy etc. In erb's palsy the most affected ranges are shoulder abduction and shoulder external rotation. Quasi experimental study will be done on the patient with erb's palsy intervention applied will be functional electrical stimulation (a low frequency current) applied 5 day a weeks for 2 weeks than on alternate days for the rest of the treatment. Setting for functional electrical stimulation will be Frequency 20 pps with Pulse width of 300 msec. 18 patient will be recruited . "Assumed population standard deviation"4.24" "Confidence level""0.95" "Acceptable error""2". Pre-intervention reading will be taken on modified mallet scale and universal goniometer and post intervention measurement will be taken after 02, 04 ,06 months.
- Conditions
- Erb's Palsy
- Being tested
- Functional Electrical Stimulation
- Medical subject headings
- Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationOther
functional electrical stimulation with Frequency 20 pps with Pulse width of 300 msec.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation | Experimental | functional electrical stimulation with Frequency 20 pps with Pulse width of 300 msec. Receives: Other: Functional Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified mallet scale Score
Modified Mallet scale evaluation of function and arm appearance. In addition to assessing the classical shoulder functions of the classical Modified Mallet system, supination and the resting position are evaluated. In the resting position, medial rotation at the shoulder is scored on a scale of 1 to 5. 1 is the lowest score and 5 is the highest score
Measured: Baseline, 2nd, 4th and 6th Months
Change in range of motion
A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry.
To measure the range of motion physical therapists most commonly use a goniometer.
Measured: Baseline, 2nd, 4th and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start30 Nov 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Erb's PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareeha Kausar, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334511
- Sponsor's protocol ID
- REC/RCR &AHS/21/0701
- Status last verified
- Feb 2023
- First submitted
- 2 Apr 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okafor UA, Akinbo SR, Sokunbi OG, Okanlawon AO, Noronha CC. Comparison of electrical stimulation and conventional physiotherapy in functional rehabilitation in Erb's palsy. Nig Q J Hosp Med. 2008 Oct-Dec;18(4):202-5. doi: 10.4314/nqjhm.v18i4.45029.
PubMed 19391320Nath RK, Somasundaram C. Significant improvement in nerve conduction, arm length, and upper extremity function after intraoperative electrical stimulation, neurolysis, and biceps tendon lengthening in obstetric brachial plexus patients. J Orthop Surg Res. 2015 Apr 19;10:51. doi: 10.1186/s13018-015-0191-y.
PubMed 25895832Huang X, Jiang Z, Sun H, Xie B, Lu F, Huang W, Wang T, Xiong H. The effect of a high-quality nursing model employing low-frequency pulse electrical stimulation combined with early systemic functional exercises on the function of the affected limb in brachial plexus injury patients. Am J Transl Res. 2021 May 15;13(5):4939-4948. eCollection 2021.
PubMed 34150078Elnaggar RK. Shoulder Function and Bone Mineralization in Children with Obstetric Brachial Plexus Injury After Neuromuscular Electrical Stimulation During Weight-Bearing Exercises. Am J Phys Med Rehabil. 2016 Apr;95(4):239-47. doi: 10.1097/PHM.0000000000000449.
PubMed 26829088
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Functional Electrical Stimulation On Functional Rehabilitation In Children With Erb's Palsy
- ClinicalTrials.gov ID
- NCT05334511
- Acronym / sponsor ID
- REC/RCR &AHS/21/0701
- Conditions
- Erb's Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 19 Apr 2022 (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.
Erb's palsy is a type of brachial plexus injury occurs in infants due to injury of nerves during childbirth. Injury causes weakness or paralysis of different muscles. Different type of approaches are made for the treatment of erb;s palsy such passive range of motion, stretching ,splinting ,electrotherapy etc. In erb's palsy the most affected ranges are shoulder abduction and shoulder external rotation. Quasi experimental study will be done on the patient with erb's palsy intervention applied will be functional electrical stimulation (a low frequency current) applied 5 day a weeks for 2 weeks than on alternate days for the rest of the treatment. Setting for functional electrical stimulation will be Frequency 20 pps with Pulse width of 300 msec. 18 patient will be recruited . "Assumed population standard deviation"4.24" "Confidence level""0.95" "Acceptable error""2". Pre-intervention reading will be taken on modified mallet scale and universal goniometer and post intervention measurement will be taken after 02, 04 ,06 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation | Experimental | Other: Functional Electrical Stimulationfunctional electrical stimulation with Frequency 20 pps with Pulse width of 300 msec. |
Who may qualify
- Ages
- 15 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with Erb's Palsy
- Children of age 15 months to 3 years
Key exclusion criteria (4 listed)
- hemiplegic cerebral palsy
- children with upper limb fractures
- obstetrical brachial plexus injury
- upper limb contracture
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 |
|---|---|---|
| Functional Electrical Stimulationfunctional electrical stimulation with Frequency 20 pps with Pulse width of 300 msec. | Other | Functional Electrical Stimulation |
Primary outcome
Change in Modified mallet scale Score
Time frame: Baseline, 2nd, 4th and 6th Months
Modified Mallet scale evaluation of function and arm appearance. In addition to assessing the classical shoulder functions of the classical Modified Mallet system, supination and the resting position are evaluated. In the resting position, medial rotation at the shoulder is scored on a scale of 1 to 5. 1 is the lowest score and 5 is the highest score
Change in range of motion
Time frame: Baseline, 2nd, 4th and 6th months
A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry. To measure the range of motion physical therapists most commonly use a goniometer.
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 21 Feb 2023.
- Background: PubMed 19391320Okafor UA, Akinbo SR, Sokunbi OG, Okanlawon AO, Noronha CC. Comparison of electrical stimulation and conventional physiotherapy in functional rehabilitation in Erb's palsy. Nig Q J Hosp Med. 2008 Oct-Dec;18(4):202-5. doi: 10.4314/nqjhm.v18i4.45029.
- Background: PubMed 25895832Nath RK, Somasundaram C. Significant improvement in nerve conduction, arm length, and upper extremity function after intraoperative electrical stimulation, neurolysis, and biceps tendon lengthening in obstetric brachial plexus patients. J Orthop Surg Res. 2015 Apr 19;10:51. doi: 10.1186/s13018-015-0191-y.
- Background: PubMed 34150078Huang X, Jiang Z, Sun H, Xie B, Lu F, Huang W, Wang T, Xiong H. The effect of a high-quality nursing model employing low-frequency pulse electrical stimulation combined with early systemic functional exercises on the function of the affected limb in brachial plexus injury patients. Am J Transl Res. 2021 May 15;13(5):4939-4948. eCollection 2021.
- Background: PubMed 26829088Elnaggar RK. Shoulder Function and Bone Mineralization in Children with Obstetric Brachial Plexus Injury After Neuromuscular Electrical Stimulation During Weight-Bearing Exercises. Am J Phys Med Rehabil. 2016 Apr;95(4):239-47. doi: 10.1097/PHM.0000000000000449.
- Individual participant dataSharing planned: No
Related trials for Erb's Palsy
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Recruiting
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
Brachial Plexus Birth Palsy, Erbs Palsy
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.
Fareeha Kausar, PP-DPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation in people with Erb's Palsy, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 4 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 21 Feb 2023. 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 Pakistan. 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?
Change in Modified mallet scale Score (time frame: Baseline, 2nd, 4th and 6th Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334511, which also lists 4 linked publications.
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 21 Feb 2023.