Erbs PalsyRESNCT06631664
Electrical Stimulation on Erbs Palsy Infants
A study testing Traditional physical therapy and A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) in people with Erbs Palsy, run by Badr University at 1 site in Saudi Arabia.
Trial summary
This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants. Read more about this study
- Who is it for?
- Ages 2 to 5 months
- Conditions the study is for
- Erbs Palsy
- What is being tested?
- Traditional physical therapy and A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 23 Apr 2023to 24 Mar 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 2 to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with OBPI limited to nerve roots C5, C6, with/without involvement of C7, partial lesion as determined by electrophysiological examinations, age between two to five months, and willingness of the infant's family to take part in the study.
Who cannot join
- Infants with clavicular or humeral fractures, complete transection of nerve roots, other neurological co-morbidities such cerebral palsy, congenital musculoskeletal deformities, or recommendation against electrical stimulation by the attending neuro-pediatrician.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Prince Sattam bin Abdul-Aziz University
Al Kharj, 11952
About this study
Official title: Contribution of Reciprocal Electrical Stimulation Across Elbow Muscles in Motor Recovery of Infants With Erbs Palsy: a Randomized Controlled Trial
This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.
Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of degeneration and motor function reaction were assessed pre-and post-treatment using electromyography and Toronto active motion scale, respectively.
Read the detailed description
This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.
Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of reaction of degeneration and motor function were assessed pre-and post-treatment using electromyography and the Toronto active motion scale respectively.
- Conditions
- Erbs Palsy
- Being tested
- Traditional physical therapy, A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA)
- Keywords
- Brachial plexus birth injury, Neuromuscular electrical stimulation, Active motion, Electroneurography, Motor function
- 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.
Traditional physical therapyOther
Participants received a traditional physical therapy program three times a week, for three successive months. Each session lasted for approximately 30 minutes and composed of the following: 1) Massage (spiral effleurage, longitudinal and transverse thumb effleurage for 5 minutes or until hyperemia), 2) Facilitation of muscle contraction through a variety of tactile and proprioceptive stimulation techniques - this was applied for the shoulder flexors, abductors, and external rotators, elbow flexors, and wrist/finger extensors. In patients whose lesion extend to involve C7, The facilitation techniques were also applied to elbow extensors. 3) Weight-bearing exercise, considering the developmental milestone (prone forearm support, prone full hand support). 4) Range of motion exercises - all joints of the affected side were moved through the full range of motion. 5) Sucking exercise.
A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA)Device
The patient was positioned in supine lying position with the affected arm beside the body and elbow extended, the skin over the anterior and posterior comportment of the upper arm was cleaned using medical cotton sacked in alcohol before the application.
The first two stimulating electrodes for the biceps muscle were placed at the superior and inferior 1/3 of anterior surface of the upper arm with a distance in between the two electrodes at least the size of one of them, while the other two electrodes for the triceps muscle were placed at the superior and inferior 1/3 of the posterior surface of the upper arm.
One millisecond pulse duration and a frequency of 50Hz with a rectangular shaped pulse were utilized and stimulation was applied for 15 minutes. At first a low-intensity current is applied and gradually increased till a gentle contraction of the muscles appears and allow time for the child to become accustomed to the current and maintained sufficient and observable contraction.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Twenty children suffering from Obstetric brachial plexus injury limited to nerve roots C5, C6, with/without involvement of C7 Receives: Other: Traditional physical therapy; Device: A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) |
| Control group | Other | Twenty children suffering from Obstetric brachial plexus injury limited to nerve roots C5, C6, with/without involvement of C7 Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of degeneration
Surface electrodes were used in a computerized electromyographic device (Neuro screen plus four channel-version, TOENNES 97204 Hochberg, Germany) to calculate the percentage of degeneration of the biceps and triceps brachii muscles.
A 1 Hz frequency and 5 ms time basis were used to create a rectangular pulse. The strength of the stimulating current was gradually raised until there was no further rise in the amplitude of the diphasic myogenic compound action potential. A 10% increase in current was given to assure supramaximal stimulation. The level of stimulation ranges from 15 to 40 mA. The Neuro screen plus system's software was used to calculate the peak-to-peak amplitude. The following equation was used to compute the percentages of degeneration:
RD= 100{Amplitude of evoked response(in µv) affected side/Amplitude of evoked response(in µv)normal side x 100}
Measured: 2 months
Toronto active motion scale (TAMS)
The motor recovery was assessed using the Toronto Active Motion Scale (TAMS). For this study, scores for elbow flexion and extension were recorded.
It consists of 15 movements of upper limb joints with an eight-point scale measuring the strength of these movements, first by measuring the range of motion at each joint with gravity eliminated, and then measuring the range of motion against gravity. The scoring of the TAMS is defined as follows:
Observation Gravity elimination Muscle grade
No muscle contraction 0 Contraction, no movement 1 Motion < range 2 Motion > range 3 Full range of movement 4
Against gravity Motion < range 5 Motion > range 6 Full range of movement 7
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start23 Apr 2023
- Primary completion27 Dec 2023
- Study completion24 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erbs 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
- Model description
- A prospective single-blind randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Hend Reda Sakr, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631664
- Sponsor's protocol ID
- Hend 6
- Acronym
- RES
- Status last verified
- Oct 2024
- First submitted
- 29 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Reciprocal Electrical Stimulation Across Elbow Muscles in Motor Recovery of Infants With Erbs Palsy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06631664
- Acronym / sponsor ID
- RES / Hend 6
- Conditions
- Erbs Palsy
- Keywords
- Brachial plexus birth injury, Neuromuscular electrical stimulation, Active motion, Electroneurography, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 24 Mar 2024 (actual)
- First posted
- 8 Oct 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.
This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.
Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of degeneration and motor function reaction were assessed pre-and post-treatment using electromyography and Toronto active motion scale, respectively.
Detailed description
This study examined the effect of reciprocal electrical stimulation (RES) across elbow flexors and extensors on the reaction of degeneration percentage and motor function in Erbs palsy infants.
Forty infants with Erb's palsy aged between 2-5 months were randomly allocated to one of two equal groups: the control group (A) received standard physical therapy, the study group (B) received traditional physical therapy plus a 15-minute RES through elbow flexors and extensors. For three months, interventions were carried out three times each week. The percentage of reaction of degeneration and motor function were assessed pre-and post-treatment using electromyography and the Toronto active motion scale respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- A prospective single-blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Traditional physical therapy, Device: A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA)Twenty children suffering from Obstetric brachial plexus injury limited to nerve roots C5, C6, with/without involvement of C7 |
| Control group | Other | Other: Traditional physical therapyTwenty children suffering from Obstetric brachial plexus injury limited to nerve roots C5, C6, with/without involvement of C7 |
Who may qualify
- Ages
- 2 to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with OBPI limited to nerve roots C5, C6, with/without involvement of C7, partial lesion as determined by electrophysiological examinations, age between two to five months, and willingness of the infant's family to take part in the study.
Key exclusion criteria (1 listed)
- Infants with clavicular or humeral fractures, complete transection of nerve roots, other neurological co-morbidities such cerebral palsy, congenital musculoskeletal deformities, or recommendation against electrical stimulation by the attending neuro-pediatrician.
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 |
|---|---|---|
| Traditional physical therapyParticipants received a traditional physical therapy program three times a week, for three successive months. Each session lasted for approximately 30 minutes and composed of the following: 1) Massage (spiral effleurage, longitudinal and transverse thumb effleurage for 5 minutes or until hyperemia), 2) Facilitation of muscle contraction through a variety of tactile and proprioceptive stimulation techniques - this was applied for the shoulder flexors, abductors, and external rotators, elbow flexors, and wrist/finger extensors. In patients whose lesion extend to involve C7, The facilitation techniques were also applied to elbow extensors. 3) Weight-bearing exercise, considering the developmental milestone (prone forearm support, prone full hand support). 4) Range of motion exercises - all joints of the affected side were moved through the full range of motion. 5) Sucking exercise. | Other | Control group, Study group |
| A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA)The patient was positioned in supine lying position with the affected arm beside the body and elbow extended, the skin over the anterior and posterior comportment of the upper arm was cleaned using medical cotton sacked in alcohol before the application. The first two stimulating electrodes for the biceps muscle were placed at the superior and inferior 1/3 of anterior surface of the upper arm with a distance in between the two electrodes at least the size of one of them, while the other two electrodes for the triceps muscle were placed at the superior and inferior 1/3 of the posterior surface of the upper arm. One millisecond pulse duration and a frequency of 50Hz with a rectangular shaped pulse were utilized and stimulation was applied for 15 minutes. At first a low-intensity current is applied and gradually increased till a gentle contraction of the muscles appears and allow time for the child to become accustomed to the current and maintained sufficient and observable contraction. | Device | Study group |
Primary outcome
Percentage of degeneration
Time frame: 2 months
Surface electrodes were used in a computerized electromyographic device (Neuro screen plus four channel-version, TOENNES 97204 Hochberg, Germany) to calculate the percentage of degeneration of the biceps and triceps brachii muscles. A 1 Hz frequency and 5 ms time basis were used to create a rectangular pulse. The strength of the stimulating current was gradually raised until there was no further rise in the amplitude of the diphasic myogenic compound action potential. A 10% increase in current was given to assure supramaximal stimulation. The level of stimulation ranges from 15 to 40 mA. The Neuro screen plus system's software was used to calculate the peak-to-peak amplitude. The following equation was used to compute the percentages of degeneration: RD= 100{Amplitude of evoked response(in µv) affected side/Amplitude of evoked response(in µv)normal side x 100}
Toronto active motion scale (TAMS)
Time frame: 2 months
The motor recovery was assessed using the Toronto Active Motion Scale (TAMS). For this study, scores for elbow flexion and extension were recorded. It consists of 15 movements of upper limb joints with an eight-point scale measuring the strength of these movements, first by measuring the range of motion at each joint with gravity eliminated, and then measuring the range of motion against gravity. The scoring of the TAMS is defined as follows: Observation Gravity elimination Muscle grade No muscle contraction 0 Contraction, no movement 1 Motion < range 2 Motion > range 3 Full range of movement 4 Against gravity Motion < range 5 Motion > range 6 Full range of movement 7
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 8 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Erbs 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.
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 Traditional physical therapy and A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) in people with Erbs Palsy, run by Badr University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 8 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 Saudi Arabia. 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?
Percentage of degeneration (time frame: 2 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?
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 8 Oct 2024.