Effects of Scapular Mobilization on Upper Limb Function

June 11, 2024 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Scapular mobilization
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
Other: Scapular mobilization
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
Other Names:
  • Standard
Active Comparator: Conventional physical therapy program
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.
Other: Conventional physical therapy program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks
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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
box and block test
Time Frame: 8 weeks
Box-and-block tests are a type of physical evaluation used to measure an individual's strength, range of motion and coordination. Scoring: Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amina Bibi, MS*, Riphah International Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/23/0756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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