Erbs PalsyNCT06198218
Effects of Scapular Mobilization on Upper Limb Function
A study testing Scapular mobilization and Conventional physical therapy program in people with Erbs Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Erb's Palsy is a physical impairment resulting from an injury to the upper trunk of the brachial plexus and is associated with paralysis of the upper limb. When the neck is stretched up and move away from the wounded shoulder while the shoulder is pressed down, damage to the top nerves that make up the brachial plexus… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Erbs Palsy
- What is being tested?
- Scapular mobilization and Conventional physical therapy program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 15 Feb 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age: between 6-9 years
- Diagnosed as obs. Erb's palsy
- Able to perform exercise
- Unilateral involvement of shoulder joint
- Unilateral active and passive movement of shoulder joint
- Both male and female involved
- Willing to participate
Who cannot join
- No history of surgery (arthroscopy, fixations)
- Any skin condition ( Allergies, infection)
- Local corticosteroids injections into the effected shoulder over last 3 months
- No present Fracture/ contractures
- Neurological disorders with muscle weakness in shoulder joint .
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Activity Based Scapular Mobilization on Upper Limb Function in Children With Erbs Palsy
Erb's Palsy is a physical impairment resulting from an injury to the upper trunk of the brachial plexus and is associated with paralysis of the upper limb. When the neck is stretched up and move away from the wounded shoulder while the shoulder is pressed down, damage to the top nerves that make up the brachial plexus is more likely to damage .These injuries occur due to traumatic activities(vehicle accidents),difficult births(breeched presentation ,prolonged labor and high birth weight).This study proposes to analyze the effects of activity based scapular mobilization on upper limb functions in children who have been diagnosed with Erb's Palsy.
This will be a randomized control trial study. Data will be collected from 30 patients who will be randomly assigned to two groups of equal numbers experimental and control group each with 15. The participants of the experimental group will be treated with scapular mobilization ,activity based scapular mobilization(codman pendulum exercises,scapular pushups, band wall apart,wall ball circles and advance study wall pushups) along with conventional physical therapy program. Participants of control group is treated with activity based scapular mobilization and conventional physical therapy program. Patient evaluation will be made at the beginning and end of the treatment. Data will be analyzed through SPSS 25.
Read the detailed description
Data will be collected from M.Islam teaching hospital Gujranwala and district health quarter Gujranwala .30 patients will be randomly assigned into two groups of equal numbers experimental and control group each with 15. Control group will receive conventional physical therapy program including ( heating to improve circulation and release muscle tension ,EMS ,stretching for stiff muscle, weight bearing, strengthening exercises and graduated active exercises)for 20 minutes along with activity based scapular mobilization( Codman pendulum exercises, ban wall apart, wall ball circles, scapular pushups and advance study wall pushups)for 20 minutes with 5 minute resting interval. Experimental group will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula. Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 minutes.
- Conditions
- Erbs Palsy
- Being tested
- Scapular mobilization, Conventional physical therapy program
- Keywords
- Erbs palsy, scapular mobilization, mallet score, codman exercises
- 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.
Scapular mobilizationOther
Also called Standard
Group A: will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula.Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 min
Conventional physical therapy programOther
Group B:will receive conventional physical therapy program including (heating to improve circulation and release muscle tension,EMS,stretching for stiff muscle,weight bearing, strengthening exercises \& graduated active exercises)for 20 min along with activity based scapular mobilization (Codman pendulum exercises,band wall apart,wall ball circles, scapular pushups and advance study wall pushups)for 20 min with 5 min resting interval.
| Study group | Role | What they receive |
|---|---|---|
| Scapular mobilization | Experimental | This Experimental group will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula. Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 minutes Receives: Other: Scapular mobilization |
| Conventional physical therapy program | Active comparator | This group will receive conventional physical therapy program including ( heating to improve circulation and release muscle tension ,EMS ,stretching for stiff muscle, weight bearing, strengthening exercises and graduated active exercises)for 20 minutes along with activity based scapular mobilization( Codman pendulum exercises, ban wall apart, wall ball circles, scapular pushups and advance study wall pushups)for 20 minutes with 5 minute resting interval. Receives: Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
A goniometer is a tool used to measure angles. It is an important tool for those studying anatomy, helping to measure the range of motion in joints. Goniometers are also used in physical therapy, engineering, and other fields.
Measured: 8 weeks
functional capacity
Box-and-block tests are a type of physical evaluation used to measure an individuals lateral rotation. Angles are measured from video stills for abduction, hand to mouth and apparent supination and estimated for lateral rotation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Dec 2023
- Primary completion31 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amina Bibi, MS*, Principal investigator, Riphah International Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198218
- Sponsor's protocol ID
- REC/RCR&AHS/23/0756
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ho ES, Curtis CG, Clarke HM. The brachial plexus outcome measure: development, internal consistency, and construct validity. J Hand Ther. 2012 Oct-Dec;25(4):406-16; quiz 417. doi: 10.1016/j.jht.2012.05.002. Epub 2012 Jul 20.
PubMed 22818900
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Activity Based Scapular Mobilization on Upper Limb Function in Children With Erbs Palsy
- ClinicalTrials.gov ID
- NCT06198218
- Acronym / sponsor ID
- REC/RCR&AHS/23/0756
- Conditions
- Erbs Palsy
- Keywords
- Erbs palsy, scapular mobilization, mallet score, codman exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 10 Jan 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.
Erb's Palsy is a physical impairment resulting from an injury to the upper trunk of the brachial plexus and is associated with paralysis of the upper limb. When the neck is stretched up and move away from the wounded shoulder while the shoulder is pressed down, damage to the top nerves that make up the brachial plexus is more likely to damage .These injuries occur due to traumatic activities(vehicle accidents),difficult births(breeched presentation ,prolonged labor and high birth weight).This study proposes to analyze the effects of activity based scapular mobilization on upper limb functions in children who have been diagnosed with Erb's Palsy.
This will be a randomized control trial study. Data will be collected from 30 patients who will be randomly assigned to two groups of equal numbers experimental and control group each with 15. The participants of the experimental group will be treated with scapular mobilization ,activity based scapular mobilization(codman pendulum exercises,scapular pushups, band wall apart,wall ball circles and advance study wall pushups) along with conventional physical therapy program. Participants of control group is treated with activity based scapular mobilization and conventional physical therapy program. Patient evaluation will be made at the beginning and end of the treatment. Data will be analyzed through SPSS 25.
Detailed description
Data will be collected from M.Islam teaching hospital Gujranwala and district health quarter Gujranwala .30 patients will be randomly assigned into two groups of equal numbers experimental and control group each with 15. Control group will receive conventional physical therapy program including ( heating to improve circulation and release muscle tension ,EMS ,stretching for stiff muscle, weight bearing, strengthening exercises and graduated active exercises)for 20 minutes along with activity based scapular mobilization( Codman pendulum exercises, ban wall apart, wall ball circles, scapular pushups and advance study wall pushups)for 20 minutes with 5 minute resting interval. Experimental group will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula. Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scapular mobilization | Experimental | Other: Scapular mobilizationThis Experimental group will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula. Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 minutes |
| Conventional physical therapy program | Active comparator | Other: Conventional physical therapy programThis group will receive conventional physical therapy program including ( heating to improve circulation and release muscle tension ,EMS ,stretching for stiff muscle, weight bearing, strengthening exercises and graduated active exercises)for 20 minutes along with activity based scapular mobilization( Codman pendulum exercises, ban wall apart, wall ball circles, scapular pushups and advance study wall pushups)for 20 minutes with 5 minute resting interval. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Age: between 6-9 years
- Diagnosed as obs. Erb's palsy
- Able to perform exercise
- Unilateral involvement of shoulder joint
- Unilateral active and passive movement of shoulder joint
Key exclusion criteria (5 listed)
- No history of surgery (arthroscopy, fixations)
- Any skin condition ( Allergies, infection)
- Local corticosteroids injections into the effected shoulder over last 3 months
- No present Fracture/ contractures
- Neurological disorders with muscle weakness in shoulder joint .
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 |
|---|---|---|
| Scapular mobilizationAlso: StandardGroup A: will be treated with manual scapular mobilization in upward rotation and downward rotation, adduction and abduction of scapula.Sets of 10 repetitions were applied with a rest interval of 30 seconds between set for 20 minutes, activity based scapular mobilization(Codman pendulum exercises, scapular pushups, band wall apart ,wall ball circles and advance study wall pushups) along with conventional physical therapy program(heating,EMS,stretching for tight muscles , strengthening exercises and graduated active exercises) for 25 min | Other | Scapular mobilization |
| Conventional physical therapy programGroup B:will receive conventional physical therapy program including (heating to improve circulation and release muscle tension,EMS,stretching for stiff muscle,weight bearing, strengthening exercises \& graduated active exercises)for 20 min along with activity based scapular mobilization (Codman pendulum exercises,band wall apart,wall ball circles, scapular pushups and advance study wall pushups)for 20 min with 5 min resting interval. | Other | Conventional physical therapy program |
Primary outcome
range of motion
Time frame: 8 weeks
A goniometer is a tool used to measure angles. It is an important tool for those studying anatomy, helping to measure the range of motion in joints. Goniometers are also used in physical therapy, engineering, and other fields.
functional capacity
Time frame: 8 weeks
Box-and-block tests are a type of physical evaluation used to measure an individuals lateral rotation. Angles are measured from video stills for abduction, hand to mouth and apparent supination and estimated for lateral rotation.
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 13 Jun 2024.
- Background: PubMed 22818900Ho ES, Curtis CG, Clarke HM. The brachial plexus outcome measure: development, internal consistency, and construct validity. J Hand Ther. 2012 Oct-Dec;25(4):406-16; quiz 417. doi: 10.1016/j.jht.2012.05.002. Epub 2012 Jul 20.
- Individual participant dataSharing planned: No
Related trials for Erbs 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.
Amina Bibi, MS* principal investigator
Riphah International Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular mobilization and Conventional physical therapy program 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 7 inclusion and 5 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 13 Jun 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 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?
range of motion (time frame: 8 weeks). 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 NCT06198218, which also lists 1 linked publication.
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 13 Jun 2024; AzTrials last refreshed its copy on 27 Oct 2026.