Erbs PalsyNCT04979689
Intensive Therapy of Shoulder External Rotators in Erb's Palsy
A study testing Intensive physical therapy and Non intensive physical therapy in people with Erbs Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Erb's palsy is a common neurological injury occurs at the time of birth. It causes injury to the upper trunk nerve root c5-c6, i.e., supply is around shoulder and muscles of forearm and these nerves network from the spine and pass through the cervicoaxillary canal in the neck and the ribs and emerge into the axilla. Read more about this study
- Who is it for?
- Ages 9 to 12 months
- Conditions the study is for
- Erbs Palsy
- What is being tested?
- Intensive physical therapy and Non intensive physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Oct 2020to 30 Jun 2021
- 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 9 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (male and female)
- Ages ranged from 9 months to 12 months
- Unilateral involvement of c5, c6 and c7
- patients did not undergo surgery of the nerves or plexus
Who cannot join
- Musculoskeletal or neuro-muscular abnormalities other than Erb's palsy
- Contractures or fixed limitations in the affected upper extremity
- Hypersensitivity to latex and adhesive tapes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Physical Rehabilitation With and Without Intensive Exercise Therapy of Shoulder External Rotators in Patients With Erb's Palsy
Erb's palsy is a common neurological injury occurs at the time of birth. It causes injury to the upper trunk nerve root c5-c6, i.e., supply is around shoulder and muscles of forearm and these nerves network from the spine and pass through the cervicoaxillary canal in the neck and the ribs and emerge into the axilla. Restoring external rotation in erb's palsy is quite difficult and mostly surgery is recommended but if physiotherapy sessions are given with extended time up to 2 hours and latest techniques are applied to strengthen external rotators then range of external rotation can be improved.
Read the detailed description
Erb's palsy is form of brachial plexus palsy which involves injury to cervical nerve roots c5 c6 causing loss of movements and deformities i.e., internally rotated shoulder, hanging arm and waiter's tip hand deformity. Most common risk factors are shoulder dystocia, maternal obesity, breech presentation and high birth weight of child. Its incidence is 0.42 per 1000 live births in which 25% experience permanent impairment and injury.
Both Conservative and non-conservative treatment protocols are applied in erb's palsy but key interventions are positioning in early infancy, passive range of motions and gentle stretching. Another latest treatment approach is intensive physical therapy in which single session duration is extended to three to four hours with combination of treatments. This study will be randomized control trial, used to check effectiveness of intensive physical therapy to restore shoulder external rotation in erb's palsy. Subjects with erb's palsy meeting the predetermined inclusion and exclusion criteria will be divided into two groups by using lottery method. Pre assessment will be done by using AROM on goniometer as objective measurement. Subject in one group will be treated with intensive physical therapy and the other with conventional treatment. Each subject will receive 5 Treatment sessions per week for 6 months.
Recorded values will be analyzed by using SPSS version 25
- Conditions
- Erbs Palsy
- Being tested
- Intensive physical therapy, Non intensive physical therapy
- Keywords
- external rotation, Intensive session, C5-C6
- 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.
Intensive physical therapyOther
Intensive physical therapy treatment protocol was given for 3 months 3 times a week including 1.5- 2-hour session. Pre and post treatment assessments were taken. It included stretching for 20 min, Proprioception on ball for 20 minutes, quadruped for 10 min, vibration therapy for 20 min, tapping twice a month for 5 days, sensory therapy with beans for 20 min, supine lying with hand below head for 10-15 min, texturing for 15 min and activity of making tower with cups and hitting in outward direction for 15-20 min.
Non intensive physical therapyOther
Non intensive therapy included 45 min session 3 times a week for 3 months. Pre and post treatment assessments were taken. The protocol included stretching for 20 min, cross friction massage for 15 min, Ball catch and throw for 15 min. progression was made from light to heavy weight ball.
| Study group | Role | What they receive |
|---|---|---|
| Intensive physical therapy | Experimental | Intensive session Receives: Other: Intensive physical therapy |
| Non intensive physical therapy | Other | Non intensive session Receives: Other: Non intensive physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified MALLET scale
A scale of 1 to 5 is used to assess shoulder abduction, global external rotation, hand to neck, hand to back and hand to mouth position. An aggregate score is calculated by summing the 5 individual scores with a maximum score of 5.
Measured: 12th weeks
Secondary outcomes (1)
Goniometer
A goniometer is an instrument which measures the available range of motion at a joint.
(Also mention all information which ROM u want to check) One BY one IN 4 and 5th number
Measured: 12th Weeks, 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start30 Oct 2020
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Erbs 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Ikram, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979689
- Sponsor's protocol ID
- REC/Lhr/21/0204 Qurat
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
@article{basit2018erb, Palsy} T, author={Basit, Hajira and Ali, Citra Dewi M and Madhani NB, Year={2018}. Erbs Palsy
Rahat S, Ahmad S, Bushra S. Role of physical therapy in improving the functional outcome of infants with Erb's palsy due to neurapraxia and Axonotmesis. Pakistan J Med Heal Sci. 2019;13(3):815-8.
Afzal F, Afzal A. Effects of Conventional Combination Physical Therapy Treatment To Improve the Gross Motor and Functional Movements in Children With Erb'S Palsy. Int J Ther Rehabil Res. 2017;6(2):70.
Sherief AAA. Electrical Stimulation Versus Arm Splint In Improving Fine More Skills In Erb's Palsy Children. Bull Fac Ph Th Cairo Univ. 2011;16(1):91-6.
Said R, Ahmed S. KINESIO ARM TAPING AS PROPHYLAXIS AGAINST THE DEVELOPMENT OF ERB ' S ENGRAM Thesis Submitted in Partial Fulfillment of the Requirements for a Master Children and Its Surgery. 2004
Malessy MJ, Pondaag W. Obstetric brachial plexus injuries. Neurosurg Clin N Am. 2009 Jan;20(1):1-14, v. doi: 10.1016/j.nec.2008.07.024.
PubMed 19064174Mazhar N, Hashmi M, Bashir S, Khan B, Khan S, Ahmad L. Physiotherapy & Physical Rehabilitation Prevalence of Erb ' s Palsy due to Shoulder Dystocia in Multan. 2019;4(3).
Kc K, Shakya S, Zhang H. Gestational diabetes mellitus and macrosomia: a literature review. Ann Nutr Metab. 2015;66 Suppl 2:14-20. doi: 10.1159/000371628. Epub 2015 Jun 2.
PubMed 26045324Frade F, Gomez-Salgado J, Jacobsohn L, Florindo-Silva F. Rehabilitation of Neonatal Brachial Plexus Palsy: Integrative Literature Review. J Clin Med. 2019 Jul 5;8(7):980. doi: 10.3390/jcm8070980.
PubMed 31284431CK O. A Case of Erb-Duchenne Palsy in a Man, Aged 24. MOJ Anat Physiol. 2017;3(6):184-6.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Physical Rehabilitation With and Without Intensive Exercise Therapy of Shoulder External Rotators in Patients With Erb's Palsy
- ClinicalTrials.gov ID
- NCT04979689
- Acronym / sponsor ID
- REC/Lhr/21/0204 Qurat
- Conditions
- Erbs Palsy
- Keywords
- external rotation, Intensive session, C5-C6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Jul 2021 (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 common neurological injury occurs at the time of birth. It causes injury to the upper trunk nerve root c5-c6, i.e., supply is around shoulder and muscles of forearm and these nerves network from the spine and pass through the cervicoaxillary canal in the neck and the ribs and emerge into the axilla. Restoring external rotation in erb's palsy is quite difficult and mostly surgery is recommended but if physiotherapy sessions are given with extended time up to 2 hours and latest techniques are applied to strengthen external rotators then range of external rotation can be improved.
Detailed description
Erb's palsy is form of brachial plexus palsy which involves injury to cervical nerve roots c5 c6 causing loss of movements and deformities i.e., internally rotated shoulder, hanging arm and waiter's tip hand deformity. Most common risk factors are shoulder dystocia, maternal obesity, breech presentation and high birth weight of child. Its incidence is 0.42 per 1000 live births in which 25% experience permanent impairment and injury.
Both Conservative and non-conservative treatment protocols are applied in erb's palsy but key interventions are positioning in early infancy, passive range of motions and gentle stretching. Another latest treatment approach is intensive physical therapy in which single session duration is extended to three to four hours with combination of treatments. This study will be randomized control trial, used to check effectiveness of intensive physical therapy to restore shoulder external rotation in erb's palsy. Subjects with erb's palsy meeting the predetermined inclusion and exclusion criteria will be divided into two groups by using lottery method. Pre assessment will be done by using AROM on goniometer as objective measurement. Subject in one group will be treated with intensive physical therapy and the other with conventional treatment. Each subject will receive 5 Treatment sessions per week for 6 months.
Recorded values will be analyzed by using SPSS version 25
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive physical therapy | Experimental | Other: Intensive physical therapyIntensive session |
| Non intensive physical therapy | Other | Other: Non intensive physical therapyNon intensive session |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children (male and female)
- Ages ranged from 9 months to 12 months
- Unilateral involvement of c5, c6 and c7
- patients did not undergo surgery of the nerves or plexus
Key exclusion criteria (3 listed)
- Musculoskeletal or neuro-muscular abnormalities other than Erb's palsy
- Contractures or fixed limitations in the affected upper extremity
- Hypersensitivity to latex and adhesive tapes
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 |
|---|---|---|
| Intensive physical therapyIntensive physical therapy treatment protocol was given for 3 months 3 times a week including 1.5- 2-hour session. Pre and post treatment assessments were taken. It included stretching for 20 min, Proprioception on ball for 20 minutes, quadruped for 10 min, vibration therapy for 20 min, tapping twice a month for 5 days, sensory therapy with beans for 20 min, supine lying with hand below head for 10-15 min, texturing for 15 min and activity of making tower with cups and hitting in outward direction for 15-20 min. | Other | Intensive physical therapy |
| Non intensive physical therapyNon intensive therapy included 45 min session 3 times a week for 3 months. Pre and post treatment assessments were taken. The protocol included stretching for 20 min, cross friction massage for 15 min, Ball catch and throw for 15 min. progression was made from light to heavy weight ball. | Other | Non intensive physical therapy |
Primary outcome
Modified MALLET scale
Time frame: 12th weeks
A scale of 1 to 5 is used to assess shoulder abduction, global external rotation, hand to neck, hand to back and hand to mouth position. An aggregate score is calculated by summing the 5 individual scores with a maximum score of 5.
1 secondary outcome
Goniometer
Time frame: 12th Weeks, 5th day
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 28 Jul 2021.
- Background@article{basit2018erb, Palsy} T, author={Basit, Hajira and Ali, Citra Dewi M and Madhani NB, Year={2018}. Erbs Palsy
- BackgroundRahat S, Ahmad S, Bushra S. Role of physical therapy in improving the functional outcome of infants with Erb's palsy due to neurapraxia and Axonotmesis. Pakistan J Med Heal Sci. 2019;13(3):815-8.
- BackgroundAfzal F, Afzal A. Effects of Conventional Combination Physical Therapy Treatment To Improve the Gross Motor and Functional Movements in Children With Erb'S Palsy. Int J Ther Rehabil Res. 2017;6(2):70.
- BackgroundSherief AAA. Electrical Stimulation Versus Arm Splint In Improving Fine More Skills In Erb's Palsy Children. Bull Fac Ph Th Cairo Univ. 2011;16(1):91-6.
- BackgroundSaid R, Ahmed S. KINESIO ARM TAPING AS PROPHYLAXIS AGAINST THE DEVELOPMENT OF ERB ' S ENGRAM Thesis Submitted in Partial Fulfillment of the Requirements for a Master Children and Its Surgery. 2004
- Background: PubMed 19064174Malessy MJ, Pondaag W. Obstetric brachial plexus injuries. Neurosurg Clin N Am. 2009 Jan;20(1):1-14, v. doi: 10.1016/j.nec.2008.07.024.
- BackgroundMazhar N, Hashmi M, Bashir S, Khan B, Khan S, Ahmad L. Physiotherapy & Physical Rehabilitation Prevalence of Erb ' s Palsy due to Shoulder Dystocia in Multan. 2019;4(3).
- Background: PubMed 26045324Kc K, Shakya S, Zhang H. Gestational diabetes mellitus and macrosomia: a literature review. Ann Nutr Metab. 2015;66 Suppl 2:14-20. doi: 10.1159/000371628. Epub 2015 Jun 2.
- Background: PubMed 31284431Frade F, Gomez-Salgado J, Jacobsohn L, Florindo-Silva F. Rehabilitation of Neonatal Brachial Plexus Palsy: Integrative Literature Review. J Clin Med. 2019 Jul 5;8(7):980. doi: 10.3390/jcm8070980.
- BackgroundCK O. A Case of Erb-Duchenne Palsy in a Man, Aged 24. MOJ Anat Physiol. 2017;3(6):184-6.
- 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.
Mehwish Ikram, MS 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 Intensive physical therapy and Non intensive physical therapy in people with Erbs 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 4 inclusion and 3 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 28 Jul 2021. 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?
Modified MALLET scale (time frame: 12th weeks). 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 NCT04979689, which also lists 10 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 28 Jul 2021.